Johnson & Johnson's One-Dose COVID Vaccine Promising in Early Trial - Consumer Health News

Johnson & Johnson’s One-Dose COVID Vaccine Promising in Early Trial – Consumer Health News

  • January 13, 2021

WEDNESDAY, Jan. 13, 2021 — A single-shot COVID-19 vaccine from Johnson & Johnson has shown very strong results in early clinical trials, potentially providing a significant boost to U.S. vaccination efforts.

The vaccine produced an immune response of all 805 clinical trial participants within two months of inoculation, according to results published Jan. 13 in the New England Journal of Medicine.

The data “are encouraging in that they show robust generation of neutralizing antibody after a single dose in a younger population and in a population older than 65 years old, and because these responses persisted for at least 71 days,” said Dr. Andrew Badley, director of the Mayo Clinic’s HIV Immunology Laboratory in Rochester, Minn.

Efforts to distribute the two currently approved vaccines from Pfizer and Moderna have run into logjams, partially because the vaccines require extreme refrigeration and people have to receive two doses to achieve immunity.

“It certainly would be very helpful, having one dose instead of two,” said Dr. Aaron Glatt, chair of the department of medicine and a hospital epidemiologist at Mount Sinai South Nassau Hospital in Oceanside, N.Y. “A lot of the logistical problems is getting that second dose, plus it takes a dose away from someone else. If you only have to give one dose, that would be great.”

The Johnson & Johnson vaccine also would be hardier than either of the already approved vaccines because it relies on DNA technology rather than messenger RNA to prompt an immune system response.

The new vaccine is made up of a deactivated cold virus into which scientists cut-and-paste a genetic version of the “spike” protein used by the coronavirus to infect cells. The immune system recognizes the incomplete and harmless coronavirus protein as an invader and mounts a response, learning how to ward off any future infections from the actual coronavirus.

The Pfizer and Moderna vaccines rely on mRNA technology that works in much the same way, but delivers the genetic coding in an oily bubble that requires freezing temperatures and delicate handling.

The new vaccine remains stable for a time in the refrigerator. “Longer-term, this can be stored in just a regular freezer like you have in your kitchen, at that temperature,” Dr. Thaddeus Stappenbeck, chair of the Department of Inflammation and Immunity at the Cleveland Clinic’s Lerner Research Institute, said of the experimental vaccine. “But it’s actually fine for several days, for extended periods of time, refrigerated.”

The latest results from phase 1-2a trials of the Johnson & Johnson vaccine involved 805 participants in two groups, one featuring folks aged 18 to 55 and the other 65 and older.

More than 90% of participants mounted an immune response within a month, and all had levels of neutralizing antibodies by day 57.

A second dose of the vaccine more than doubled the amounts of neutralizing antibodies, the results showed.

It will be results from phase 3 clinical trials involving 45,000 participants that determine whether a single dose or two doses actually create lasting immune protection against COVID-19.

“It’s very possible that the single dose will work, but it’s not uncommon for vaccinations to require a booster,” Stappenbeck said. “If this is slightly better with a booster, it would be worth getting the second shot.”

Early results from the phase 3 trials are expected by the end of January, Johnson & Johnson has said.

“It will be essential to confirm these findings in phase 3 clinical trials, where efficacy of the vaccine against the virus can be determined,” said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore.

Stappenbeck expects if the phase 3 results “are as strong as the data they saw with the mRNA vaccines, then the goal would be to wrap it up quickly and apply for emergency use authorization. It could happen by the end of January. That’s what I’ve heard.”

The phase 1-2a results also showed a similar safety profile to the existing vaccines, researchers reported. Fever was the most frequent adverse response, as well as fatigue, headache and body aches.

“The safety looks great. It’s very much in line with what’s been seen with the mRNA vaccine,” Stappenbeck said.

Johnson & Johnson briefly paused its vaccine trial in October after a volunteer developed an unexplained neurological illness. A safety investigation determined that the illness was not related to the vaccine.

A similar COVID vaccine developed by AstraZeneca and Oxford University that relies on coronavirus DNA delivered through an inactivated cold virus also suffered delays based on safety concerns. Britain and India have authorized the vaccine for use, according to The New York Times.

Although the Johnson & Johnson vaccine would provide a needed third option, it’s not yet clear how quickly the company will be able to get doses into arms.

The pharmaceutical giant pledged in its $1 billion contract with the U.S. federal government to have 12 million doses of its vaccine ready by the end of February and ramp up to a total 100 million doses by the end of June, the Times reported Wednesday.

However, federal officials have been told the company is as far as two months behind its original production schedule, the Times added. It’s not expected to catch up until the end of April, by when it was to have delivered more than 60 million doses.

More information

The U.S. Centers for Disease Control and Prevention has more about viral vector COVID-19 vaccines.

SOURCES: Andrew Badley, MD, director, Mayo Clinic’s HIV Immunology Laboratory, Rochester, Minn.; Aaron Glatt, MD, chair, department of medicine, and hospital epidemiologist, Mount Sinai South Nassau, Oceanside, N.Y.; Thaddeus Stappenbeck, MD, PhD, chair, Department of Inflammation and Immunity, Cleveland Clinic’s Lerner Research Institute, Ohio; Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore; New England Journal of Medicine, Jan. 13, 2021; New York Times

Volunteers share Sanofi Pasteur/GSK COVID-19 vaccine trial experiences

Volunteers share Sanofi Pasteur/GSK COVID-19 vaccine trial experiences

  • December 30, 2020

Peninsula Research Associates, based in Rolling Hills Estates, California, began operating in September as one of 10 testing sites nationwide to partake in a vaccine trial developed in partnership between pharmaceutical companies Sanofi Pasteur and GlaxoSmithKline.

This study’s vaccine includes adjuvants, which are ingredients that help vaccines work better at boosting the immune system to develop antibodies against COVID-19.

Phase one included a total of 441 volunteers, 73 of whom were located at the California clinic. All trial participants received one vaccination on the first day and a booster shot on day 22 if they were a part of the group receiving two doses. The ratio was an eight-to-two randomization of active to placebo, dependent on participants age.

“There’s numerous different reasons why people want to participate in our trial,” said Jordan Wertheimer, vice president of clinical operations at Peninsula Research Associates. “There’s a lot of patients who had family members test positive for COVID-19, some who passed away. A lot of people also just want to help humanity.”

Early data shows there is a clear differentiation between the two groups of trial participants; two doses are far more effective than one dose, according to Wertheimer.

Right now, Peninsula Research Associates and the other testing sites are awaiting protocols to begin Phase 2B in February 2021. The amount of patients for this phase remains unclear.

In December, a data readout revealed Sanofi Pasteur/GSK had halted the next phase of the study in order to fix the antigen concentration of their vaccine so that a higher rate of antibodies would develop. If the vaccine meets all clinical requirements and is approved by authorities, it could possibly be expected in circulation toward the end of 2021, the companies said in a press release.

“With due time, we’re hopefully going to have multiple vaccines for the physicians, the health departments and the counties all to be able to use,” said Dr. Lawrence Sher, allergist and immunologist at Peninsula Research Associates. “It’s important that we have it all out there and not consider it a race, rather, consider it production of more and more excellent vaccines. We are doing something for the greater good, which is a good feeling.”

“We’re very excited for the opportunity to work on this kind of study,” Wertheimer said. “We just want to do our part to help progress medicine forward. We’re really apt on participating in the next studies and just coming out with a vaccine to help eradicate this.”

Two volunteers involved in Peninsula Research Associates’ trial spoke with ABC News about what motivated them to join the vaccine study. Here are their stories.

The loss of a loved one

Pat Brewster, 84, lost her husband, Bob, due to the effects of COVID-19.

Prior to his coronavirus diagnosis, Bob was living in a hospice facility to receive care for Parkinson’s disease, Brewster said. On April 4, she noticed an abnormal tremor in both of her husband’s hands, which prompted her to call for a caregiver to examine him.

A low-grade fever, among other symptoms, left Bob’s doctor presuming he had a gastrointestinal virus, not COVID-19. But Brewster decided to have paramedics transport her husband to a hospital for further examination. The 88-year-old tested positive for COVID-19 on April 10 and died at the hospital three days later.

Brewster twice tested negative for COVID-19. When she received word by mailing list about a vaccine study happening locally near her Rancho Palos Verdes home in California, she jumped on the opportunity to raise awareness.

“This seemed about the only thing I could do to fight this illness,” she said. “This disease is real. A lot of people don’t think it is, or it won’t affect them. To see people not taking the precautions, I just feel like screaming, you know? It’s not just the people who die, it affects the families, too.”

Brewster joined the Sanofi Pasteur/GSK study in September, which she recalls involved a lot of forms and paperwork. During the first visit, Brewster received a urine test, blood test, nasal swab and one vaccine injection. She said she did not experience any side effects.

“I was given a chart and had to take my temperature every day for the next week or so,” she explained. “I think I went back in after two weeks and did another urine and blood test. I had a telephone conference in November, and now I don’t go back in until January.”

Due to her age, Brewster may be eligible to receive a vaccine that is currently in circulation, from Pfizer or Moderna. If the opportunity arises, the study she’s participating in will reveal whether she received the placebo or the vaccine in order to ensure she receives the best form of protection against COVID-19.

“This year has been a year of heartbreak and deprivation,” Brewster concluded. “We are still in a very dangerous stage of this pandemic. But as we head into the new year, we are armed now with hope, with more knowledge of the virus than we had originally and with the promise of highly effective vaccines. We all have a responsibility to protect ourselves and others, to do whatever we can to fight this vicious and stealthy virus.”

Giving back to the community

Debbie Hays, 59, is no stranger to helping her community for the greater good. But COVID-19 also hits too close to home. Her 79-year-old mother, who lives in an assisted living facility and has dementia, is currently battling the illness.

So when her friend reached out asking to spread the word for volunteers in the Sanofi Pasteur/GSK study, Hays jumped into action and put her own name in the hat.

“I’m one who always gives back to the community but more on the level of neighborhood cleanup or getting groceries for those who need them,” Hays said. “I never thought I’d be a part of a biomedical research study. But then I decided, ‘Hey, why not?’ It’s just nice to be able to give back to humanity in this way.”

“I’m in perfect health, so that’s another reason why I decided I could take one for the team,” she added.

According to the Torrance, California, resident, her experience in the trial thus far has been “very painless and easy.”

Intake involved a blood draw, a urine sample, temperatures taken, a health questionnaire and a vaccine, she said. Hays monitored her temperature and any changes in health on a chart at home for eight days. She then went back to the clinic to be evaluated and receive a second shot, as she was part of the trial group who received a booster vaccine.

“Some patients are on a one-shot program,” she said. “I happened to be on the two shot program. They’re trying to determine if the vaccine is strong enough to be taken care of in one or two doses.”

Hays then repeated the charting process for another eight days. She said she has not experienced any side effects to date.

“The team is really fantastic,” she said. “They explain everything so there are no surprises. They’re appreciative of us participating, and their follow-through is excellent.”

Bharat Biotech is conducting a phase 3 study with 26,000 participants.pti (MINT_PRINT)

Covaxin found to be safe, effective in phase 2 trial

  • December 24, 2020

Bharat Biotech’s indigenous vaccine Covaxin induced immunity against covid-19 through antibodies as well as T-cells and was found to be safe with no serious adverse events during its first two stages of trial, a pre-print of the phase 2 study showed.

“It is hypothesised that the humoral and cell-mediated responses reported in this study may persist until at least 6-12 months after the second vaccination dose,” showed the trial report, which is yet to be peer-reviewed.

Also Read | Inside the farmer disquiet at Delhi’s doorstep

Humoral immune responses are caused by antibodies, while cell-mediated responses are caused by T-cells, which are major components of the adaptive immune system whose roles include killing infected host cells, activating other immune cells, producing cytokines and regulating the immune response. They are the second level of the body’s immune system after antibodies that are meant to attach to the pathogen and stop it from infecting cells.

“BBV152 induced binding (to both spike- and nucleocapsid protein epitopes) and neutralizing antibody responses that were similar to those induced by other SARS-CoV-2 inactivated vaccine candidates,” the study showed, adding that a sizeable memory T-cell population was also observed three months after the second and final dose was given.

The vaccine was tested in 380 healthy children and adults as part of the phase 2 immunogencity study, with half of them getting a 3 microgram of antigen, along with adjuvant, and the rest getting twice that dose of antigen and the adjuvant.

The primary objective of the study was to determine seroconversion—how many of the participants showed antibodies in their immune system—while the secondary outcome was to determine the safety and side-effects.

Covaxin was shown to induce T-cell memory responses and showed the ability to make the body secrete spike-specific IgG antibodies. An inactivated vaccine is basically a dead coronavirus, with the company also using an adjuvant to boost the immune response.

A pre-print of the company safety data in phase 1 trials was also released last week. It showed that one of the nearly 300 participants who were part of the vaccine arms of the Covaxin phase 1 trial showed serious side-effect during the trial. The side-effect was deemed as not related to the vaccine, showing that the shots were safe to use.

The company said that the study had several strengths, including the fact that it enrolled participants with a wide range of ages and found no differences in immune responses across age groups.

Davinder Gill, a vaccine expert in the US, said in the phase 2 trial, Bharat Biotech seemed to want to fix the dose for its phase 3 trial and later, and found that the 6 microgram dose with the adjuvant was more effective at inducing the production of neutralizing antibodies.

“Compared to the data that I have seen in other phase 2 studies from AstraZeneca, Pfizer and Moderna, Bharat Biotech for sure put out a lot more data. They have looked at various ways of measuring antibodies and various ways to look at neutralizing antibodies. But on the flipside, instead of more data, I would have liked to see a phase 2 maybe in 1,000-1,200 subjects, particularly because they were expanding the age group from 18-55 to 12-65 years,” Gill said.

Bharat Biotech is currently conducting a phase 3 study of 26,000 participants to determine the efficacy of the vaccine.

Subscribe to Mint Newsletters

* Enter a valid email

* Thank you for subscribing to our newsletter.

Clinical trial explores nutritional support to improve immune response to COVID-19

Clinical trial explores nutritional support to improve immune response to COVID-19

  • December 11, 2020

MIAMI – A clinical trial is underway at sites in Miami and around the country to examine whether nutritional support can benefit patients exposed to or infected with COVID-19.

The outpatient study was designed to asses the effects of restoring and maintaining a healthy digestive system.

Researchers are testing an investigational powdered food product to see if it can improve the balance of microbes in the gut.

“By boosting the balance of the digestive system, you can not only get a boost in the balance, but the theory is that you will get a boost as well in the immune system, and the beauty about this is it might not only help COVID-19 patients, which is the primary focus of our study right now, but you can also get that information and try to use it in other infections overall,” said Dr. Jose Pinero, who is the lead investigator.

Patients can participate at home in one of four locations throughout South Florida by clicking here.

In other health news, while there were initial concerns about the mental health impact of COVID-19 on the elderly, recent data shows older Americans are very resilient.

A group of researchers at institutions around the country looked at early data from several global studies on the relationship between older adults and mental health during the pandemic and found they were less negatively affected than younger adults.

One report from the Centers for Disease Control and Prevention found that older adults were less likely to start or increase substance abuse and less likely to think about suicide.

Copyright 2020 by WPLG Local10.com – All rights reserved.

Coronavirus: UK to trial vaccine combos in bid to boost immunity against Covid

Coronavirus: UK to trial vaccine combos in bid to boost immunity against Covid

  • December 8, 2020

Known as a heterologous prime-boost, the treatment can only be administered with licensed jabs and involves using a dose each from two different vaccines.

Kate Bingham, outgoing chair of the UK’s vaccine taskforce, said the government was intending to launch a “mix and match” trial next month.

Participants in the study will receive one shot of the PfizerBioNTech vaccine, which was last week licensed for use by the UK’s drug regulator, and one dose of the Oxford-AstraZeneca jab — assuming it is approved in time.

The vaccine developed by Moderna will also be included if it is given the green light by the Medicines and Healthcare Products Regulatory Agency.

Sir Patrick Vallance, the government’s chief scientific adviser, said the treatment was a “pretty standard way of boosting the immune system”.

“What it means is that you give one vaccine to get the immune system triggered up and another one to then boost it further with a different vaccine — that’s an established way of getting the immune system geed up,” he told Sky News on Tuesday.

“But that needs to be looked at — you can’t assume that it will work. It needs to be tested properly, and that’s one of the things about all of these vaccines and all of the clinical trials of medicines is you need to do the trials properly, you need to make sure you test these things.”

The vaccines manufactured by Pfizer and Moderna have each been shown to be 95 per cent effective in preventing Covid-19 disease. They make use of new mRNA technology, which appears to generate a bigger antibody response than other vaccine platforms.

Questions remain over the precise efficaciousness of the Oxford/AstraZeneca jab, which is 62 per cent effective when administered as two full doses. This figure rises to 90 per cent if applied as a half dose followed by a full dose.

Under a heterologous prime-boost, doses from the different vaccines would be combined, in different orders, to help enhance the body’s immune response to Sars-CoV-2 – the virus responsible for Covid-19.

“No one’s ever done it live and since we’ll have safe vaccines available we should do that study, because then we have the ability to actually produce better immune responses,” Clive Dix, deputy chair of the UK’s vaccine taskforce, said during a scientific briefing.

“There is a slight benefit to it, too, in that if prime and boosting either way around work, it may help with the deployment, because it might just be simpler to deploy that way round, but the main reason is to get a stronger immune response.”

The UK government has ordered 100m doses of the Oxford jab, 40m doses of the Pfizer candidate and 7m Moderna shots, with the vast majority of supplies set to be delivered in the new year.

Ms Bingham said the January trials were not about making limited stocks of the vaccines go further.

“It’s not being done because of supplies,” she said. “It’s to do with trying to trigger the immune response and the durability and nothing to do with what vaccines we’ve got.”

When asked if the UK could purchase more doses, Ms Bingham said: “It depends by contract. So some we have options to extend and others we’ve got fixed numbers of doses.”

Health secretary Matt Hancock has meanwhile said the government is hopeful that approval for the Oxford-AstraZeneca vaccine will be granted in the coming weeks.

“We very much hope that that will get approval,” he said on Tuesday. “We hope that to come through in the next couple of weeks.

“It has to be a decision for the independent MHRA, who will only approve it if it is safe to use and effective. So that works underway. And I wouldn’t expect anything for the next couple of weeks.”

Ms Bingham said she was also optimistic that the vaccine will be licensed for emergency use.

The comments come as the vaccine taskforce released a report looking at its work and achievements six months after it was set-up to help in the fight against Covid-19.

According to the report, the taskforce has worked decisively and at great pace in the face of the pandemic.

Prime minister Boris Johnson said: “The approval of the Pfizer/BioNTech vaccine for use in the UK marks a momentous step in our fight against Covid-19.

CEL-SCI Announces Update on Phase 3 Cancer Trial Results

CEL-SCI Announces Update on Phase 3 Cancer Trial Results

  • December 7, 2020

VIENNA, Va.–()–CEL-SCI Corporation (NYSE American: CVM) announced today that the Phase 3 study is in the final stage of review which involves statistical analysis of all study data. Data lock has already been completed.

Since the required number of events to allow statistical analysis of CEL-SCI’s Phase 3 study in head and neck cancer was reached earlier this year, the Clinical Research Organizations (CROs) managing CEL-SCI’s Phase 3 study, Ergomed and ICON, had been performing data base lock of the study results. Data base lock is a very important and time intensive process that needs to be completed to ensure any study’s data are accurate and as complete as possible before the results of the study can be statistically evaluated and reliable conclusions drawn regarding the study’s outcome(s). This process was particularly complicated for CEL-SCI’s Phase 3 study because the study was conducted in over 20 countries on three continents, and many of these countries had, and still have, severe shutdowns due to the COVID-19 pandemic.

The statistical analysis of our Phase 3 study data is being performed according to a statistical analysis plan that was approved in advance of data lock. The analysis is being conducted by independent unbiased contractors. CEL-SCI is not involved in this process. Once the analysis has been completed, CEL-SCI will become privy to the study results. At that time, shareholders will be advised of the results through a public announcement. CEL-SCI also plans to publish the results in peer reviewed scientific journals.

“Our goal has been to create a cancer drug that is both non-toxic and works with the body’s immune system to increase the ‘intent to cure’ success rate of the first-line cancer treatment. We believe that immunotherapy should be administered before, not after, surgery, radiation and chemotherapy have damaged the immune system. We further believe that success in head and neck cancer should lead to many new ways of helping cancer patients.” said Geert Kersten, CEO of CEL-SCI Corporation. “We are grateful to our shareholders for believing in us and supporting us during the very long Phase 3 study.”

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen right after diagnosis and prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system “see” the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the statistical analysis phase.

The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment for COVID-19 infection. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. When used in this press release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical trials or nonclinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K/A for the year ended September 30, 2019. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

Early trial results show Sinovac vaccine triggers immune response | China

Early trial results show Sinovac vaccine triggers immune response | China

  • November 18, 2020

Sinovac Biotech’s experimental COVID-19 vaccine CoronaVac triggered a quick immune response but the level of antibodies produced was lower than in people who had recovered from the disease, early trial results showed on Wednesday.

While the early to mid-stage trials were not designed to assess the efficacy of CoronaVac, researchers said it could provide sufficient protection, based on their experience with other vaccines and data from preclinical studies with macaques.

The study follows encouraging announcements this month from US drugmakers Pfizer and Moderna, as well as Russia’s Sputnik V, that their experimental vaccines were more than 90 percent effective based on interim data from large, late-stage trials.

CoronaVac and four other experimental vaccines developed in China are currently undergoing late-stage trials to determine their effectiveness in preventing COVID-19.

The Sinovac findings, published in a peer-reviewed paper in the medical journal The Lancet Infectious Diseases, came from results in Phase I and Phase II clinical trials in China involving more than 700 participants.

“Our findings show that CoronaVac is capable of inducing a quick antibody response within four weeks of immunisation by giving two doses of the vaccine at a 14-day interval,” said Zhu Fengcai of the Jiangsu Provincial Center for Disease Control and Prevention in Nanjing and one of the authors of the paper.

CoronaVac is one of three experimental COVID-19 vaccines China has been using to inoculate hundreds of thousands of people under its emergency use programme [File: Thomas Peter/Reuters]

“We believe that this makes the vaccine suitable for emergency use during the pandemic,” Zhu said in a statement published alongside the paper.

Among the Phase II trials limitations, the researchers noted that only healthy adults were involved and that the study did not include individuals from groups known to be more susceptible to COVID-19 including people of 60 years of age or more, or with other underlying diseases.

It also did not assess T-cell responses, which they said would form part of the Phase III trials in Brazil. Phase III trials are also under way in Indonesia and Brazil, which has reported the most coronavirus cases in the world after the United States and India.

Findings from those large, late-stage studies would be crucial to determine if the immune response generated by CoronaVac was sufficient to protect people from the coronavirus infection, the scientists said.

Naor Bar-Zeev from Johns Hopkins University, who was not involved in the study, said the results must be interpreted with caution until Phase III results are published.

“But even then, after Phase III trial completion and after licensure, we should prudently remain cautious,” he said.

 

 

‘Attractive option’

CoronaVac is one of three experimental COVID-19 vaccines China has been using to inoculate hundreds of thousands of people under its emergency use programme.

The two other vaccines in China’s emergency programme, both developed by institutes linked to Sinopharm, and another vaccine from CanSino Biologics, were also shown to be safe and triggered immune responses in early and mid-stage trials, according to peer-reviewed papers.

Gang Zeng, a Sinovac researcher involved in the CoronaVac study, said the vaccine could be an attractive option because it can be stored at normal fridge temperatures of between 2 and 8 degrees Celsius (36°- 46°F) and may remain stable for up to three years.

“(It) would offer some advantages for distribution to regions where access to refrigeration is challenging,” Gang said.

Sinovac is running late stage, large-scale trials of its experimental vaccines in Brazil, Indonesia and Turkey [File: Diego Vara/Reuters]

By contrast, vaccines developed by Pfizer/BioNTech and Moderna use a new technology called synthetic messenger RNA (mRNA) to activate the immune system against the virus and require far colder storage.

Pfizer’s vaccine must be stored and transported at -70C though it can be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box. Moderna’s candidate is expected to be stable at normal fridge temperatures for 30 days but for storage of up to six months it needs to be kept at -20C.

CoronaVac is also being considered by Brazil and Indonesia for inoculations in the coming months.

Indonesia has sought emergency authorisation to start a mass vaccination campaign by the end of the year and vaccines produced by Sinovac and China’s Sinopharm are slated to be used in the early stages of the campaign.

Brazil’s Sao Paulo is set to begin importing the first of 46 million doses of China’s Sinovac vaccine against COVID-19 this week and plans to roll out CoronaVac as early as January.

Bonn Group launches ''immunity-boosting'' herb and seeds bread

Chinese COVID-19 vaccine candidate shows promise in human trial: Study

  • October 16, 2020
Beijing, Oct 16 (PTI) One of China”s leading COVID-19 vaccine candidates, called BBIBP-CorV, was shown to be safe and elicited immune response in a small early-phase human trial, researchers said on Friday.

A previous clinical trial reported similar results for a different vaccine that is also based on inactivated whole SARS-CoV-2 virus, but in that study the vaccine was only tested in people aged under 60 years.

The latest study, published in The Lancet Infectious Diseases journal, included participants aged between 18 and 80 years, and found that antibody responses were induced in all recipients.

Participants aged 60 and over were slower to respond, taking 42 days before antibodies were detected in all recipients compared with 28 days for participants aged 18-59, the researchers said.

Antibody levels were also lower in those aged 60-80 years compared with those aged 18-59, they said.

The BBIBP-CorV vaccine used in the study is based on a sample of the virus that was isolated from a patient in China.

Stocks of the virus were grown in the lab using cell lines and then inactivated using a chemical called beta-proprionolactone.

BBIBP-CorV includes the killed virus mixed with another component, aluminium hydroxide, which is called an adjuvant because it is known to boost immune responses.

The trial was not designed to assess efficacy of the vaccine, so it is not possible to say whether the antibody responses induced by the vaccine, called BBIBP-CorV, are sufficient to protect from SARS-CoV-2 infection, according to the researchers.

“Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease,” said Professor Xiaoming Yang, one of the authors of the study, from the Beijing Institute of Biological Products Company Limited.

“However, vaccines are sometimes less effective in this group because the immune system weakens with age. It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation,” said Yang.

There are currently 42 vaccines for COVID-19 in clinical trials, the researchers noted.

These vary in type and include DNA plasmid vaccines, inactivated virus vaccines, adenovirus-vectored vaccines, RNA vaccines, protein subunit vaccines and virus-like particle vaccines, they said.

Some of these have already been shown to be safe and to elicit immune responses in early phase clinical trials.

The first phase of the study involved 96 healthy volunteers aged between 18 and 59 years and a second group of 96 participants aged between 60 years and 80 years.

Within each group, the vaccine was tested at three different dose levels, with two vaccinations administered on day 0 and 28.

A fourth group within each age group were given two doses of a placebo vaccine.

In the second phase of the study, 448 participants aged between 18 and 59 years were randomly assigned to receive either one 8 microgramme shot of vaccine or placebo, or two shots of 4 microgramme vaccine or placebo.

No serious adverse events were reported within 28 days of the final vaccination, and the most common side effect was pain at the injection site, the researchers said.

There were no instances of clinically significant changes in organ functions detected in laboratory tests in any of the groups, they said.

The greatest antibody responses were elicited by two 4 microgramme doses of the vaccine at either days 0 and 21 or 0 and 28, according to the resaerchers.

“Our findings indicate that a booster shot is necessary to achieve the greatest antibody responses against SARS-CoV-2 and could be important for protection. This provides useful information for a phase 3 trial,” Yang said.

The researchers noted some limitations with the study, including the short duration of follow up at just 42 days.

They also highlighted that the study did not include children and adolescents aged under 18.

” More studies are needed to establish whether the inactivated SARS-CoV-2 vaccines are capable of inducing and maintaining virus-specific T-cell responses,” said Professor Larisa Rudenko from the Institute of Experimental Medicine, Russia, who was not involved in the study.

This is because CD4-positive T-cell help is important for optimal antibody responses, as well as for cytotoxic CD8-positive T-cell activation, which, in turn, are crucial for viral clearance if neutralising antibody-mediated protection is incomplete, Rudenko said. PTI SAR
SAR



Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI


More from Outlook Magazine

New COVID-19 Antibody Trial Underway at University of Minnesota

New COVID-19 Antibody Trial Underway at University of Minnesota

  • October 15, 2020

(TNS) – The University of Minnesota is leading recruitment for a federally funded COVID-19 trial to find out if purified virus-fighting antibodies from as many as 10 donors can effectively treat one severe case of the infectious disease.

 

The trial is an extension of the plasma therapies that have received federal emergency use authorization to treat COVID-19 but with uneven results because antibody levels vary in the plasma donated by people who have recovered from the disease.

 

“If you’re a lucky person to get enough of the antibodies in the plasma infusion you receive, it may work,” said James Neaton, who directs the U’s INSIGHT network that will enroll patients worldwide for the new trial. “But a very high percentage of the plasma infusions that were done had levels that did not seem to achieve the benefit that you would like.”

 

The study treatment is called anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG, and is being developed for the trial through a partnership of four pharmaceutical companies.

 

The National Institute of Allergy and Infectious Diseases (NAIAD) formally launched the trial last week, seeking 500 patients through the U’s recruitment. Half will receive hIVIG and the remainder will receive a placebo saline solution for comparison. All patients must be hospitalized and also receive remdesivir, an approved antiviral drug for COVID-19.

 

NAIAD’s director, Dr. Anthony Fauci, said in a statement that the treatment will hopefully “give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.”

 

Better oxygen management and two proven drugs have reduced COVID-19 mortality and the average length of hospital stays, but there is still pressure to come up with improved treatments in the absence of a vaccine and amid a new wave of infections.

 

The Minnesota Department of Health on Wednesday reported a total of more than 115,000 infections with the novel coronavirus that causes COVID-19 and 2,180 deaths. The total included 29 deaths newly reported Wednesday, the highest single-day total since June 4.

 

The 487 Minnesotans admitted to hospitals for COVID-19 in the seven-day period ending Oct. 11 was the highest total since the first peak of the pandemic in May.

 

“There’s a lot of pressure to find treatments particularly for hospitalized patients,” Neaton said. “We feel that pressure. It’s taken longer to get this trial going actually because of the difficulty of getting enough plasma and enough treatments to begin the study.”

 

Antibody therapies have been hot topics of late, spurred by President Donald Trump’s claim last week that an experimental antibody cocktail made by Regeneron was a “cure” for his recent COVID-19 illness.

 

A synthetic antibody therapy made by Eli Lilly is part of a federally funded COVID-19 trial that paused its recruiting on Tuesday because of unspecified safety concerns found by the data safety and monitoring board that is overseeing it.

 

The U’s INSIGHT also was leading recruiting of hospitalized patients for that trial based on its track record of success in enrolling patients for studies of drugs to fight other infections such as influenza and HIV.

 

Pauses in trials are common as enrollees’ health issues are evaluated to determine if they are due to the experimental therapies they received.

 

“It could be that everything will be just fine and things will resume in two weeks,” Neaton said. “If not, then we’ll be able to see some data that currently we’re not privy to see” to explain what went wrong.

 

Intravenous immunoglobulin infusions are already used to treat infections such as cytomegalovirus, but nonetheless present risks for COVID-19 patients, Neaton said.

 

The goal is to use a purified and measurable dosage of antibodies from multiple donors and to give it to patients early enough to stop the virus from wreaking havoc in the lungs and other organs. However, many COVID-19 deaths are not due to the virus, but rather the overreaction by the human immune system to infection.

 

Neaton said the study will assess whether the hIVIG avoids or exacerbates that immune system response.

 

“That is a potential risk of therapies like this,” he said.

 

Four enrollees have already joined the study, which will recruit at more than 50 sites worldwide — including at HCMC and the Minneapolis VA Medical Center.

 

Minnesota has been antibody central when it comes to the study of COVID-19 diagnostics and therapies. The U and Mayo Clinic were among the first in the nation to develop and deploy highly accurate tests for COVID-19 antibodies — proteins produced in response to infection with the coronavirus.

 

Mayo coordinated a national expanded access program in which donor plasma from recovered COVID-19 patients was administered to newly infected patients. Enrollment halted in August after the program gained more than 105,000 participants and provided enough evidence to the U.S. Food and Drug Administration to grant emergency use authorization for the therapy.

 

Mayo researchers are now conducting a methodical review of the recipients and their outcomes over time to assess the effectiveness of the single-donor plasma therapies, said Dr. R. Scott Wright, who coordinated the national program. Initial data to the FDA had suggested plasma reduced COVID-19 mortality, but conclusions were hampered by the lack of a control group who received standard care for comparison.

 

“We are honored to have been a part of this and humbled by the response from so many patients and hospitals,” Wright said.

 

Neaton said the U-led network hopes to have recruited enough hospitalized COVID-19 patients in December. Analysis after that will determine if antibodies refined from multiple plasma donors were more effective than from single donors.

 

Neaton noted that the U had led a prior study of intravenous immunoglobulin against seasonal influenza, but it failed to show a benefit. There had been some evidence it worked against illnesses caused by B strains of influenza, and the U was preparing a follow-up study earlier this year when the COVID-19 pandemic emerged and the research agenda changed.

 

Jeremy Olson • 612-673-7744

 

———

 

©2020 the Star Tribune (Minneapolis)

 

Visit the Star Tribune (Minneapolis) at www.startribune.com

 

Distributed by Tribune Content Agency, LLC.

 

University of Minnesota leads recruitment to new COVID-19 antibody trial

University of Minnesota leads recruitment to new COVID-19 antibody trial

  • October 14, 2020

The University of Minnesota is leading recruitment for a federally funded COVID-19 trial to find out if purified virus-fighting antibodies from as many as 10 donors can effectively treat one severe case of the infectious disease.

The trial is an extension of the plasma therapies that have received federal emergency use authorization to treat COVID-19 but with uneven results because antibody levels vary in the plasma donated by people who have recovered from the disease.

“If you’re a lucky person to get enough of the antibodies in the plasma infusion you receive, it may work,” said James Neaton, who directs the U’s INSIGHT network that will enroll patients worldwide for the new trial. “But a very high percentage of the plasma infusions that were done had levels that did not seem to achieve the benefit that you would like.”

The study treatment is called anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG, and is being developed for the trial through a partnership of four pharmaceutical companies.

The National Institute of Allergy and Infectious Diseases (NAIAD) formally launched the trial last week, seeking 500 patients through the U’s recruitment. Half will receive hIVIG and the remainder will receive a placebo saline solution for comparison. All patients must be hospitalized and also receive remdesivir, an approved antiviral drug for COVID-19.

NAIAD’s director, Dr. Anthony Fauci, said in a statement that the treatment will hopefully “give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.”

Better oxygen management and two proven drugs have reduced COVID-19 mortality and the average length of hospital stays, but there is still pressure to come up with improved treatments in the absence of a vaccine and amid a new wave of infections.

The Minnesota Department of Health on Wednesday reported a total of more than 115,000 infections with the novel coronavirus that causes COVID-19 and 2,180 deaths. The total included 29 deaths newly reported Wednesday, the highest single-day total since June 4.

The 487 Minnesotans admitted to hospitals for COVID-19 in the seven-day period ending Oct. 11 was the highest total since the first peak of the pandemic in May.

“There’s a lot of pressure to find treatments particularly for hospitalized patients,” Neaton said. “We feel that pressure. It’s taken longer to get this trial going actually because of the difficulty of getting enough plasma and enough treatments to begin the study.”

Antibody therapies have been hot topics of late, spurred by President Donald Trump’s claim last week that an experimental antibody cocktail made by Regeneron was a “cure” for his recent COVID-19 illness.

A synthetic antibody therapy made by Eli Lilly is part of a federally funded COVID-19 trial that paused its recruiting on Tuesday because of unspecified safety concerns found by the data safety and monitoring board that is overseeing it.

The U’s INSIGHT also was leading recruiting of hospitalized patients for that trial based on its track record of success in enrolling patients for studies of drugs to fight other infections such as influenza and HIV.

Pauses in trials are common as enrollees’ health issues are evaluated to determine if they are due to the experimental therapies they received.

“It could be that everything will be just fine and things will resume in two weeks,” Neaton said. “If not, then we’ll be able to see some data that currently we’re not privy to see” to explain what went wrong.

Intravenous immunoglobulin infusions are already used to treat infections such as cytomegalovirus, but nonetheless present risks for COVID-19 patients, Neaton said.

The goal is to use a purified and measurable dosage of antibodies from multiple donors and to give it to patients early enough to stop the virus from wreaking havoc in the lungs and other organs. However, many COVID-19 deaths are not due to the virus, but rather the overreaction by the human immune system to infection.

Neaton said the study will assess whether the hIVIG avoids or exacerbates that immune system response.

“That is a potential risk of therapies like this,” he said.

Four enrollees have already joined the study, which will recruit at more than 50 sites worldwide — including at HCMC and the Minneapolis VA Medical Center.

Minnesota has been antibody central when it comes to the study of COVID-19 diagnostics and therapies. The U and Mayo Clinic were among the first in the nation to develop and deploy highly accurate tests for COVID-19 antibodies — proteins produced in response to infection with the coronavirus.

Mayo coordinated a national expanded access program in which donor plasma from recovered COVID-19 patients was administered to newly infected patients. Enrollment halted in August after the program gained more than 105,000 participants and provided enough evidence to the U.S. Food and Drug Administration to grant emergency use authorization for the therapy.

Mayo researchers are now conducting a methodical review of the recipients and their outcomes over time to assess the effectiveness of the single-donor plasma therapies, said Dr. R. Scott Wright, who coordinated the national program. Initial data to the FDA had suggested plasma reduced COVID-19 mortality, but conclusions were hampered by the lack of a control group who received standard care for comparison.

“We are honored to have been a part of this and humbled by the response from so many patients and hospitals,” Wright said.

Neaton said the U-led network hopes to have recruited enough hospitalized COVID-19 patients in December. Analysis after that will determine if antibodies refined from multiple plasma donors were more effective than from single donors.

Neaton noted that the U had led a prior study of intravenous immunoglobulin against seasonal influenza, but it failed to show a benefit. There had been some evidence it worked against illnesses caused by B strains of influenza, and the U was preparing a follow-up study earlier this year when the COVID-19 pandemic emerged and the research agenda changed.

 

 

rn{% endblock %}"},"start":"https://users.startribune.com/placement/1/environment/3/limit-signup-optimizely/start"},{"id":"limit-signup","count":12,"action":"ignore","mute":true,"action_config":{"template":"{% extends "grid" %}rnrn{% block heading_text %}Youu2019ve read your 10 free articles for this 30 day period. Sign up now for local coverage you wonu2019t find anywhere else, special sections and your favorite columnists. StarTribune puts Minnesota and the world right at your fingertips. {% endblock %}rnrn{% block last %}rn{{ parent() }}rn{# limit Krux pixel from https://www.squishlist.com/strib/customshop/328/ #}rnrnrn{% endblock %}"},"start":"https://users.startribune.com/placement/1/environment/3/limit-signup/start"},{"id":"meter-desktop-331","count":10,"action":"ignore","mute":false,"action_config":false,"start":"https://users.startribune.com/placement/1/environment/3/meter-desktop-331/start"},{"id":"PDA991499opt","count":9,"action":"ignore","mute":true,"action_config":false,"start":"https://users.startribune.com/placement/1/environment/3/PDA991499opt/start"},{"id":"limit","count":8,"action":"inject","mute":false,"action_config":{"template":"

rnrnrnrn

rn

rn

rn rn

rn t

rn SUBSCRIBErn Already a subscriber? Log in.rn

rn

All Star Tribune readers without a Digital Access subscription are given a limited number of complimentary articles every 30 days. Once the article limit is reached we ask readers to purchase a subscription including Digital Access to continue reading. Digital Access is included in all multi-day paper home delivery, Sunday + Digital, and Premium Digital Access subscriptions. After the 1 month Premium Digital Access introductory period you will be charged at a rate of $14.99 per month. You can see all subscription options or login to an existing subscription herern

rn rn

rn

rn

rn

rn

rn"},"start":"https://users.startribune.com/placement/1/environment/3/limit/start"},{"id":"nag","count":7,"action":"lightbox","mute":true,"action_config":{"height":null,"width":"630px","redirect_on_close":null,"template":"{% extends "shell" %}rnrn{% block substyles %}rn

rn{% endblock %}rnrn{% block page %}rn{#rnrn{{ limit - count - 1 }}rnrn{{ form.flow_form_open({nextAction: 'firstSlide'}, null, null, '_top') }}rn {{ form.btn('Save Now') }}rn{{ form.flow_form_close() }}rnrn

rnrnrnu2022 rnrnrnrn#}rn

rn

rn

You have {{ limit - count - 1 }} articles left

rn

rn rn u00a0u00a0u2022u00a0u00a0rn rn

rn

rn

rn

rn Save More Todayrn

Over 70% off!

rn

rn

rn

rn

99u00a2 for first 4 weeks

rn {{ form.flow_form_open({nextAction: 'firstSlide'}, null, null, '_top') }}rn {{ form.button('Save Now', 'btn nag-btn') }}rn {{ form.flow_form_close() }}rn

rn

rn{% endblock %}rnrn{% block last %}rn{{ parent() }}rnrn{% endblock %}"},"start":"https://users.startribune.com/placement/1/environment/3/nag/start"},{"id":"x","count":4,"action":"ignore","mute":true,"action_config":false,"start":"https://users.startribune.com/placement/1/environment/3/x/start"},{"id":"multi-start","count":3,"action":"fly_in","mute":true,"action_config":{"location":"bottom_left","slide_direction":"bottom","group_id":null,"display_delay":"0","collapse_delay":"10","template":"

rn

rn

rn

rn u00d7rn

rn

rn

From just

rn

$3.79 99u00a2 a week

rn Save nowrn

rn

rn

"},"start":"https://users.startribune.com/placement/1/environment/3/multi-start/start"}]};

Do NOT follow this link or you will be banned from the site!