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


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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.

 

 

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Large Trial Will Test Whether BCG Vaccine Protects Against COVID-19 in Healthcare Staff

Large Trial Will Test Whether BCG Vaccine Protects Against COVID-19 in Healthcare Staff

  • October 12, 2020

A largescale global trial designed to test the theory that the widely-used BCG vaccine could help protect against COVID-19 will soon recruit healthcare staff and care home workers in the UK.

The University of Exeter is leading the UK arm of the trial, called the ‘BCG vaccination to Reduce the impact of COVID-19 in healthcare workers’ (BRACE) Trial.

The BRACE trial is coordinated by the Murdoch Children’s Research Institute (MCRI) in Melbourne, Australia. The trial has received more than $10M from the Bill and Melinda Gates Foundation to allow its global expansion. The Peter Sowerby Foundation has contributed funding to support the Exeter trial site.

The UK joins study centres in Australia, the Netherlands, Spain, and Brazil in the largest trial of its kind. Together, the trial will recruit more than 10,000 healthcare staff. Participants will be given either the BCG vaccine (currently given to more than 100 million babies worldwide each year to protect against tuberculosis (TB)) or a placebo injection. In the UK, routine BCG vaccination was stopped in 2005 because of low rates of TB in the general population.

Professor John Campbell, of the University of Exeter Medical School, is the UK lead on the BRACE study. He said: “COVID-19 has killed more than a million people globally, with well over 33 million people acquiring the disease, sometimes in its severest forms. BCG has been shown to boost immunity in a generalised way, which may offer some protection against COVID-19. We’re excited to be contributing to the large-scale, international BRACE study where we are seeking to establish whether the BCG vaccine could help protect people who are at risk of COVID-19. If it does, we could save lives by administering or topping up this readily available and cost-effective vaccination.”

Previous studies suggest that the Bacillus Calmette-Guerin (BCG) vaccine could reduce susceptibility to a range of infections caused by viruses including those similar to the novel coronavirus causing COVID-19. Examining the mechanism by which this may work is part of the trial being conducted by BRACE researchers.

The BCG vaccine boosts immunity by ‘training’ the immune system to respond to other subsequent infections with greater intensity.

Researchers hope this improved ‘innate immunity’ will buy crucial time to develop an effective and safe vaccine against COVID-19.

The BRACE trial is initially recruiting care and healthcare workers in the South West of England, who can attend clinics in Exeter. The trial is targeting these professionals because they work in fields with high exposure to COVID-19. The trial is specifically looking at whether the BCG vaccine reduces coronavirus infection or COVID-19 symptom severity.

Professor Campbell added: “People on the COVID-19 front line, including healthcare workers and care home workers, are particularly vulnerable to coronavirus infection. Up until now, care home workers have been overlooked by most research. The BRACE trial provides us with a great opportunity to offer potential help to this important group of individuals who are providing healthcare to some of our most vulnerable citizens in important community settings. I’d really encourage care-home staff to join us, to help us find out if the BCG vaccine might provide a safe, widely available and cost-effective way to reduce the risk of COVID-19.”

In the UK, the trial will be conducted by the Exeter Clinical Trials Unit and supported by the local National Institute for Health Research funded Clinical Research Facility. Lynne Quinn, Operations Director of Exeter CTU, said the trial is initially seeking to recruit 1,000 participants who work in care homes and other community healthcare settings. She said: “The first wave of recruitment will take place in and around Exeter, and we have exciting plans to expand to other sites across the UK, so we hope to be expanding our recruitment numbers at a later stage.”

Professor Nigel Curtis, global lead of the BRACE trial at MCRI, said: “We are delighted that the UK is joining this international trial to help determine if we can repurpose an existing safe vaccine to reduce the impact of COVID-19 in healthcare workers, including those working in care homes who are at particular risk.”

Participants will be asked to complete a daily symptom diary via an app, be tested for COVID-19 whenever they have symptoms, complete regular questionnaires and provide blood samples. These samples will allow scientists to understand how blood cells respond differently to exposure to COVID-19 and other viruses, with and without the BCG vaccine.

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.


Coronavirus: UK launches clinical trial of BCG vaccine | Coronavirus outbreak

  • October 10, 2020

Doctors in the UK have launched a clinical trial to see whether the cheap and widely available BCG vaccine can boost the immune system enough to prevent healthcare workers from catching coronavirus.

The Bacillus Calmette–Guérin (BCG) vaccine is given to protect people from tuberculosis, but studies suggest that it stimulates broader immune responses that help the body keep other infections at bay.

Researchers at Exeter University are enrolling up to 2,000 community healthcare workers, particularly from care homes and GP surgeries, including nurses, caterers and admin staff, for the UK arm of the international Brace trial, which is recruiting 10,000 volunteers worldwide.

Prof John Campbell, at the University of Exeter Medical School, said the vaccine would be a “global game-changer” if it helped prevent people from falling ill with the virus and passing it on to others.

Volunteers for the trial will receive a shot of BCG or a placebo and be monitored for a year to see whether the vaccinated group pick up fewer Covid-19 infections and have less severe illness. The trial could release preliminary results in six to nine months.

While BCG raises a specific immune response against TB, a bacterial disease, studies have found that the vaccine can also protect against viral infections.

Last month, an international team of scientists published trial results in the journal Cell showing that elderly people had substantially fewer respiratory infections after having the vaccine. In the trial, 42.3% of the placebo group caught viral infections, compared with only a quarter of those who had the jab.

“If we see anything close to that sort of protection for coronavirus, this could be a global game changer,” Campbell said.

The primary goal of a vaccine is to stimulate what is called the adaptive immune system. This is the body’s highly targeted second line of defence that unleashes antibodies and T cells to wipe out invading pathogens. The BCG vaccine is designed to do this for TB, but it also boosts the “innate” immune system, the faster but less targeted frontline defence that tries to see off any kind of infection before it takes hold.

Since the pandemic began, scientists have found evidence that BCG vaccination may help to reduce Covid-19 deaths, but the results are mixed and contested. If the trial proves that BCG works against coronavirus, Campbell said it could buy the world crucial time to develop the more effective and targeted vaccines needed to bring the pandemic under control. It could also be rolled out in future pandemics if found to protect against viral infections generally.

Mihia Netea, a researcher at Radboud University in the Netherlands, said BCG appears to train the body’s first line of defence and make it more active against future infections. “We think that in a non-vaccinated person, the virus comes in and starts to multiply, but the host defences are slow, so the virus has a chance to multiply a lot,” he said. “With BCG we want to strengthen that initial response, to make the immune system fight hard and fight early, so the virus does not have a chance to multiply.”

“If we can show this is true now, in this pandemic, then BCG can be used in any future pandemic, because there will be more. It could be used immediately,” he said.

Can a plasma-based treatment boost Gilead's remdesivir? NIH starts phase 3 trial to find out

Can a plasma-based treatment boost Gilead’s remdesivir? NIH starts phase 3 trial to find out

  • October 9, 2020

When the first placebo-controlled data for Gilead’s remdesivir came out, analysts agreed it was no “silver bullet” for COVID-19. But it didn’t have to be, said Gilead CEO Daniel O’Day, who saw it as a stepping stone to other treatments and one that could even be combined to work better. Now, the National Institutes of Health will test that theory as it kicks off a global study pairing the antiviral drug with plasma-based treatments.

The phase 3 trial will pit the combination against remdesivir plus placebo in 500 adult patients who have been hospitalized with COVID-19. It will take place in 18 countries across the globe and will assess patients’ health status after seven days of treatment. The patients will have had symptoms for 12 days or fewer, and not suffer from life-threatening organ dysfunction or organ failure. If all goes to plan, investigators will follow patients for 28 days.

Several companies will provide the plasma-based treatments: Emergent BioSolutions and Grifols will supply one, while a Takeda and CSL-Behring led group, dubbed the CoVIg-19 Plasma Alliance, will provide the other treatment, called CoVIg-19.

Webinar

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RELATED: Takeda, CSL-led alliance and NIH to test COVID-19 plasma treatment this summer

Known as hyperimmune globulins, the treatments are made by purifying antibodies from plasma donated by people who have recovered from COVID-19. Because it is purified and concentrated, the plasma carries much higher levels of neutralizing antibodies than patients who have survived infection do. The investigators figure that giving patients the treatment when symptoms first appear, but before the body has had a chance to make its own antibodies, could boost patients’ immune response to SARS-CoV-2, the virus that causes COVID-19.

“Finding safe and effective treatments for COVID-19 is absolutely critical,” Anthony Fauci, M.D., director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a statement. “The ITAC trial will examine whether adding anti-coronavirus hIVIG to a remdesivir regimen can give the immune system a needed boost to suppress SARS-CoV-2 early in the course of illness, nipping the infection in the bud.” 

RELATED: Takeda, CSL-led plasma players band together on COVID-19

Before forming the alliance, Takeda started working on its own hyperimmune globulin against the coronavirus, but it quickly realized that joining forces with other plasma players would be the fastest way to a treatment. The group includes companies from Australia, the U.K., Switzerland, Germany and France.

RELATED: COVID-19 close-up: Takeda’s Morabito on the science behind plasma-based treatments

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” Julie Kim, president of Takeda’s plasma-derived therapies unit and co-leader of the CoVIg-19 Alliance, said in a statement.

“This study will help us understand how CoVIg-19 could potentially become an important therapeutic option,” Kim added. “To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”

The CoVIg-19 Alliance hopes to see the study read out by the end of the year, Bill Mezzanotte, M.D., the group’s other co-leader and CSL Behring’s chief medical officer and R&D chief, said in the statement.

Drug used to treat President Trump involved in Fort Pierce clinical trial

Drug used to treat President Trump involved in Fort Pierce clinical trial

  • October 5, 2020

FORT PIERCE, Fla. — One part of President Donald Trump’s care for COVID-19 has been the use of a new antibody drug cocktail. That drug is now available in a local clinical trial.

In recent weeks, Dr. Moti Ramgopal has seen his COVID-19 patient load drop from more than 100 to about 20.

“Wearing masks is such an important part in preventing the spread of COVID,” said Dr. Ramgopal with the Midway Immunology and Research Center.

Now, the Fort Pierce infectious disease doctor is engaging in another potential game changer in the coronavirus fight.

His office taking part in a clinical trial involving an experimental antibody cocktail by Regeneron, the same one President Donald Trump was given.

“These are antibodies that are injected into our system that boost our immune system to fight the virus or to activity against the virus,” Dr. Ramgopal said.

Dr. Ramgopal said it can be used not just with hospitalized patients, but also for those who may have been exposed at home.

At nearby Lawnwood Regional Medical Center, the hospital was one of the first in Florida to use remdesivir as a treatment option.

The drug saving the life of a St. Lucie West Centennial High School student.

“And we’ve come a long way from there. You remember early on, we had no options it was just supportive treatment for patients who came in with a viral syndrome,” said Dr. Michael Bakerman, the chief of medicine at Lawnwood Regional Medical Center.

Dr. Bakerman said the president’s care has generally followed what they would do.

“We’d really like to be aggressive early on rather than coming in at the back end, so his treatment is generally following those principles,” Dr. Bakerman said.

With flu season approaching and COVID still here, Dr. Bakerman is advising people to a flu shot, wear a mask, social distance, and wash your hands.

If you want to enroll in the clinical trial in Fort Pierce, call 772-595-9830.

Covid vaccine: Trial of new coronavirus vaccine starts in UK

Covid vaccine: Trial of new coronavirus vaccine starts in UK

  • September 25, 2020

Person being jabbed

Image copyright
Novavax

A trial of a new vaccine that appears to train the immune system to fight coronavirus has begun in the UK.

Early tests showed the jab, developed by US biotechnology company Novavax, leads to high levels of virus-fighting antibodies being produced.

The trial on 10,000 people will now see if the vaccine can prevent people getting ill.

The UK government has already ordered 60 million doses in case it proves successful.

A vaccine that can protect people from Covid-19 is still widely seen as the main exit strategy from the restrictions on all our lives.

The Novavax jab is only the second to enter large scale trials in the UK; the other has been developed by the University of Oxford.

Some of the vaccines being developed for Covid-19 use either completely new or barely proven technologies.

Novavax are using traditional methods – proteins from the coronavirus that cannot replicate in the body and a chemical, called an adjuvant, to boost the immune response.

“It’s a technology that we are more familiar with,” Prof Paul Heath, who is leading the trial at St George’s University Hospitals NHS Foundation Trust, told the BBC.

He added: “This is an open field and we don’t know what will work, that is the truthful answer here,. And that’s the reason there are so many different vaccine candidates.”

Early trial data on 83 people, published in the New England Journal of Medicine, showed the vaccine appeared safe.

Blood samples from those injected showed the volunteers were producing antibodies that could neutralise the coronavirus and another part of the immune system, called T-cells, were also trained to fight the virus.

While this is a promising sign, it is not enough to prove the vaccine can either stop infection or prevent someone developing the severest form of the disease.

Ten thousand people will take part in the trial and at least a quarter of them will be over 65, the age-group most at risk of severe Covid-19.

The volunteers will be picked from those who have signed up to take part in clinical trials run by the NHS.

Half will be given two doses of the vaccine, three weeks apart, and the rest will be given a dummy jab called a placebo.

However, it will take months – probably early 2021 – before we know if the vaccine is successful.

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Novavax

Image caption

The vaccine has been tested in animals and small numbers of people already

“This is a really exciting moment, this is only the second phase three efficacy trial in the UK,” Prof Heath told the BBC.

“This vaccine looks like an excellent candidate to be protective against Covid-19, but we need now to prove that.”

The vaccine will be manufactured in Stockton-on-Tees.

Kate Bingham, chairwoman of the government’s Vaccines Taskforce, said: “Finding a safe and effective vaccine that works for the majority of the UK population is the best way to tackle this devastating disease.

“Whilst social distancing, testing and other measures can help reduce the impact of coronavirus, the only long-term solution to beating it will be finding a vaccine.”

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Coronavirus: Monoclonal antibodies to begin UK trial

Coronavirus: Monoclonal antibodies to begin UK trial

  • September 14, 2020

Illustration of antibodies attacking the coronavirus

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Science Photo Library

Image caption

Illustration of antibodies attacking the coronavirus

A new antibody treatment is to be trialled on Covid-19 patients in UK hospitals.

Monoclonal antibodies, which are potent, laboratory-made antibodies, will be given to about 2,000 people to see if they are effective against coronavirus.

It forms part of the UK Recovery Trial, which found that a cheap steroid called dexamethasone could save lives.

The first patients will be given the new drugs in the coming weeks.

Prof Martin Landray from the University of Oxford, who is co-leading the Recovery Trial, said: “This is the first type of treatment that’s targeted for this specific virus.

“There are lots of good reasons for thinking it might well be effective – stopping the virus from reproducing, stopping the virus from causing damage, improving survival for patients.

“We need to know, and the way to know is to do the trials that will tell us whether that hope turns into reality.”

What are monoclonal antibodies?

Antibodies could be described as the “warriors” of the immune system.

When coronavirus infects your body, antibodies attach to the spikes of the virus, blocking it from entering your cells.

But we produce many different types of antibodies – the most potent are called neutralising antibodies.

So scientists “sieve” through them to find the one that’s best at sticking to the spike.

The chosen antibody is multiplied in the lab, and produced in huge quantities.

This is then given to patients, immediately boosting their immune response.

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Media captionThe BBC’s Rebecca Morelle explains how the monoclonal antibodies work

Which monoclonal antibodies are being used in the trial?

The trial will test a mixture of two monoclonal antibodies made by the US biotech company Regeneron.

Both attach to the spike of the virus at slightly different places. So if the virus mutates, and the structure changes, at least one should still work.

Regeneron has already produced monoclonal antibodies that can treat Ebola.

Leah Lipsich, vice president of the company, said: “We’re hoping that we can springboard from that very effective result against Ebola to something that’s just as effective with Covid-19.”

How will the trial work?

The UK Recovery Trial was set up at the start of the pandemic to identify treatments that could help people admitted to hospital with Covid-19.

It has already showed the steroid dexamethasone cuts the risk of death by a third for patients on ventilators, and by a fifth for those on oxygen.

Patients will start being given monoclonal antibodies in the next few weeks, and the results will be compared with other patients who have not been given the antibodies.

Prof Landray expects that about 2,000 people in each group will be needed to answer key questions.

He said: “We need to understand not only if these treatments work. We also need to understand in whom do they work, and in whom do they work best.

“Do they work in people who are older or younger? Do they work in people with more severe or milder disease? Do they work in people only when they’re on ventilators or, possibly more likely, before they ever need ventilators?”

The results will also be compared with people receiving convalescent plasma, another treatment currently undergoing trials by the Recovery team. This is where plasma, the yellowish, liquid part of blood, is taken from people who’ve recovered from coronavirus and given to patients.

The Recovery Trial is also looking at azithromycin, a commonly used antibiotic, and tocilizumab, an anti-inflammatory treatment.

Which other diseases are monoclonal antibodies used for?

Monoclonal antibodies have been used clinically since the 1980s, and are used to treat many diseases including some forms of cancer.

But because they are a relatively new technology, they can be expensive.

The price for the Covid treatment has not yet been set.

But Prof Landray says if it works, fair access to all patients, internationally, is an issue that needs to be considered.

Do we still need treatments if we have a vaccine?

Some vaccines are entering the final phase of trials, but none are near being ready to roll out.

And with Covid cases rising, people are still being hospitalised and some are dying.

Apart from dexamethasone and another cheap steroid, hydrocortisone, there are no other clinically proven treatments for Covid-19, so finding new ways to help patients is vital.

But even once we do have a vaccine, treatments will continue to play a role.

Leah Lipsich, from Regeneron, said: “There will be populations – the immunocompromised, the elderly – who may not mount a sufficient immune response to a vaccine and will require treatment.

“And we feel very strongly that these highly potent neutralising antibodies really will help boost the immune response, and will always be needed even even when a vaccine is available.”

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Israeli revolutionary Alzheimer’s treatment to launch Phase 1 trial

Israeli revolutionary Alzheimer’s treatment to launch Phase 1 trial

  • September 10, 2020
A novel treatment for Alzheimer’s developed by one of Israel’s top scientists is preparing to launch a Phase 1 clinical trial and, if successful, it could change the course of Alzheimer’s disease and arrest its progression.The therapy, developed by ImmunoBrain Checkpoint and based on 20 years of work by Prof. Michal Schwartz of the Weizmann Institute of Science demonstrating that the immune system is needed for the maintenance of healthy brain function and repair, would contribute to the understanding of the biology of Alzheimer’s disease. The Phase I trial will specifically test ImmunoBrain Checkpoint’s proprietary antibody, IBC-Ab002, which is targeted to enhance the immune system and induce brain repair processes in individuals with Alzheimer’s disease. Earlier this month, the company won a $1 million grant from the Alzheimer’s Association to help get them closer to the trial. Schwartz, who is now the company’s chief scientist, is considered one of Israel’s most renowned scientists. A recipient of the EMET Prize, she made revolutionary contributions to brain research, showing the role of the immune system in maintaining the brain’s health, and helping mitigate its dysfunction. Her studies led to her current approach of developing immunotherapies for Alzheimer’s disease and dementia, never even considered before. “The brain is isolated from the blood by barriers that are collectively called the blood brain barrier,” Schwartz explained. “Although the brain is the highest tissue in terms of consumption of oxygen and it is dependent on robust blood supply, there is no direct contact between the blood vessels and the brain’s tissue. Accordingly, the brain has long been considered to be isolated from the immune system.”Since the middle of the last century, the dogma has been that immune cells are not allowed to enter the brain under any circumstances, and if they do enter, it is a sign of pathology. But Schwartz’s team challenged this dogma and broke it by discovering that there are beneficial and necessary relationships between the brain and the immune system in health and disease.“My journey started more than 20 years ago,” she told The Jerusalem Post. “I was challenging the issue under the initial assumption that it does not make sense that the brain, the most precious and indispensable organ in our body, could not benefit from the immune system for support and repair.”Ultimately, Schwartz discovered that cognitive performance of the brain is impaired if the immune system is compromised. Moreover, she found that in Alzheimer’s disease and dementia the function of the immune system affects the timing of disease onset and the way it progresses, and that boosting the immune system can modify the disease.“Through step-by-step understanding of the underlying mechanisms, we were able to propose and develop an immunotherapy that will empower the immune system to help the brain to combat Alzheimer’s disease, dementia and other diseases,” she said. ImmunoBrain Checkpoint reached out to Schwartz and licensed her technology, moving it from the laboratory to the company.  Schwartz said that although this is only a Phase 1 study, it should prove both safety and proof of mechanism. Currently, there are no approved therapies for Alzheimer’s disease that can modify the disease course, despite the illness plaguing so many people. According to Schwartz, as the population ages, Alzheimer’s is expected to be among the most prevalent diseases. “There are no cures and the number of cases is going up,” she said, “and since it is not life-threatening like cancer – people live for several years not knowing their identity – it is terrible. It does not kill you, but it kills your personality and it is a burden on society.”She recalled how when the late actor Robin Williams began developing the dementia he said that if he could not reboot his brain he would commit suicide, which is ultimately what he did. “It is a devastating and insulting disease,” Schwartz said. The Phase 1 trial will cost $16 million and Shchwartz said that so far they have raised $4 million. The company is actively fundraising. “It is not the best time for fundraising because of coronavirus – we have to do everything via Zoom,” she said. But she is not deterred. She said the company is submitting all of the paperwork to the Food and Drug Administration this month and they hope to be ready to start the trial in nine months. She assumes the Phase 1 trial itself will take another 10 months to a year to complete.How long until it hits the market, if successful?“It should not be very long, but we will know more after the Phase 1 trial,” she said.

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