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One of China’s leading COVID-19 vaccine candidates, called BBIBP-CorV, was proven 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’s 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 most recent 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, carrying 42 days before antibodies were detected in all recipients in comparison to 28 days for participants aged 18-59, the researchers said.
The BBIBP-CorV vaccine used in the analysis is based on a sample of the virus that was isolated from a patient in China.
Stocks of the virus have been grown in the laboratory using cell lines and then inactivated with a compound called beta-proprionolactone.
BBIBP-CorV comprises the killed virus mixed with another element, aluminium hydroxide, which can be known as an adjuvant because it is proven to boost immune responses.
The trial wasn’t designed to assess efficacy of the vaccine, so it’s impossible to say whether the antibody responses induced by the vaccine, known as BBIBP-CorV, are enough to protect from SARS-CoV-2 infection, according to the researchers.
“Protecting older people is a key purpose of a successful COVID-19 vaccine as this age group is at higher risk of severe illness from the disease,” said Professor Xiaoming Yang, one of the authors of this 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 form 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 stage 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 has been 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 stage 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 severe adverse events have been reported within 28 days of the end 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 those groups, they said.
The best antibody responses were elicited by 2 4 microgramme doses of the vaccine at either days 0 and 21 or 0 and 28, according to the resaerchers.
“Our findings suggest that a booster shot is necessary to achieve the greatest antibody responses against SARS-CoV-2 and might be important for security. This provides useful information for a phase 3 trial,” Yang said.
The researchers noted some limitations with the study, for instance, brief duration of follow up at only 42 days.
They also emphasized that the analysis 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 answers,” 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 essential 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 faulty, Rudenko said.
