CanSino coronavirus vaccine appears safe in first human trial

Pair of studies showed vaccine prevented coronavirus infection in monkeys; produced antibodies

Dr Daniel Barouch, director of vaccine research at Beth Israel Deaconess Medical Center in Boston, who was not involved in the work, acknowledged that "this is a promising data" but added that it is "early data". The antibody response to the vaccine in the high dose group was slightly greater than that in the middle dose and low dose groups, CanSino said. Researchers saw a stronger ramp-up of other immune compounds, called T-cells, that might also help fight the infection off.

The vaccine candidate was well tolerated at all doses with no serious adverse events reported within 28 days of vaccination.

Since January, when we began to see the COVID-19 epidemic grow in Wuhan, the scientific and pharmaceutical community has been on a quest to develop a vaccine that will end the pandemic, avert further outbreaks and prevent deaths.

It's not yet clear whether the shot - if it proves effective - will be available in the U.S., and the Department of Health and Human Services had not responded to request for comment at the time of publication. "The trial demonstrates that a single dose of the new adenovirus type 5 vectored Covid-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days", said study co-author Wei Chen from the Beijing Institute of Biotechnology.

Furthermore, after 28 days, the majority of recipients showed either a positive T cell response or had detectable neutralizing antibodies against SARS-CoV-2 (low-dose group 28/36, 78%; medium-dose group 33/36, 92%; high-dose group 36/36, 100%).

Levels of neutralizing antibodies - a type of immune cell that binds to a virus and may be able to completely block infection - were closely monitored too.

By the second week after vaccination, everyone had moderate increase in these important immune cells. Mean titer for neutralising antibody in the high-dose group was noted to be 34.0, while it stood at 16.2 in the middle and 14.5 in the low-dose group.

Levels of these antibodies were more than twice as high among the participants who got the high dose shot, compared to those given the low dose.

Although three different doses were used, all the monkeys' viral loads peaked on day two at around the same levels and declined thereafter to become undetectable between days 21-28.

An ideal vaccine is expected to generate both antibody and T cells that defend the body from the virus. "Rigorous clinical studies will be required to determine whether SARS-CoV-2 infection effectively protects against SARS-CoV-2 re-exposure in humans", they said.

The most common side effects were mild pain at the injection site, mild fever, fatigue, headache and muscle pain, the study said.

- Proteins - such as the spike protein - or virus-like particles that allow the body to learn to identify the virus without being exposed to it (because it would be exposed to the outermost part of the virus, not the genetic material it uses to reproduce).

Many of them said they were concerned the vaccine would be riskier than the disease itself because development is moving so fast.

So far, the U.S. government is supporting the development of 14 candidate vaccinations through its Operation Speed initiative. However this is not the final trials and the overall results would be evaluated in six months.

"These results support further development of ShaCoVacc as a candidate vaccine for Covid-19", the researchers wrote in the study, which has not yet been peer reviewed.

This article has been adapted from its original source.



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