The first phase of clinical trials of the vaccine was conducted in 108 healthy adults, aged 18 to 60 years, and shows “promising results” after 28 days.
The results of the first phase of clinical trials of a candidate to vaccine in China demonstrate that it is safe, well tolerated and capable of generating an immune response against coronavirus COVID-19 in humans.
The person responsible for this clinical trial -the vaccine has to pass three phases- is the Institute of Biotechnology of Beijing, in China, and their results are published in the scientific journal The Lancet.
The study was done in 108 healthy adults between 18 and 60 years and shows “promising results” after 28 days, according to the authors, who nevertheless point out that more tests are needed to know if the immune response it causes effectively protects against infection. SARS-CoV-2.
“These results represent an important milestone,” says Wei Chen of the Beijing Biotechnology Institute, for whom this trial demonstrates that a single dose of the new vaccine, which uses an adenovirus type 5 vector (Ad5-nCoV), produces in 14 days antibodies specific against viruses and T cells, a type of white blood cell that plays a key role in the immune response.
This makes it “a potential candidate for further investigation, ”says Chen, who nonetheless points out that the results should be interpreted with caution.
And it is that, according to The Lancet, the ability to trigger immune responses It does not necessarily indicate that the vaccine will protect humans from the disease.
Study of 108 adults finds vaccine produced neutralizing antibodies and T-cell response against SARS-CoV-2, but further research is needed to confirm whether the vaccine protects against # SARSCoV2 infection (3/3) pic.twitter.com/Bwh0jZfnYb
– The Lancet (@TheLancet) May 22, 2020
“This result shows a promising vision for the vaccine development, but we are still a long way from making it available to everyone, “emphasizes Chen.
As the magazine explains, the vaccine candidate evaluated in this test It is the first one that has been human tested.
The vaccine, which has the participation of the company Canino, was well tolerated at all doses, with no serious adverse events reported within 28 days after vaccination; in any case, most were mild or moderate.
The most common adverse reactions were mild pain, fever, fatigue, headache and Muscle pain.
Within two weeks of vaccination, all vaccine dose levels triggered some level of immune response in the form of binding antibodies (which can bind to the coronavirus but do not necessarily attack it); some of the participants had detectable neutralizing antibodies against SARS-CoV-2.
This also occurred after 28 days, where the majority quadrupled the binding antibodies; half of the participants who received low and medium vaccination doses, and three-quarters of those in the high-dose group showed neutralizing antibodies against SARS-CoV-2.
The vaccine also stimulated a rapid response from T cells in most of the volunteers, which was higher in those who received the high and medium doses of the vaccine.
The authors note that the main limitations of the trial are the small sample size, the relatively short duration and the lack of a control group randomized, limiting the ability to detect more rare adverse reactions to the vaccine or to provide strong evidence of its ability to generate a immune reaction.
In the city of Wuhan Phase 2 of the trial began to determine if the results can be replicated and if there are any adverse events for up to six months after vaccination.
500 healthy adults participate, 250 volunteers those who were given a medium dose, 125 who were given a low dose and 125 who were given a placebo as a control.
For the first time, participants over 60 years, an important population that is the target of the vaccine.
Earlier this week, the American pharmacist Modern He reported the “positive” results of his vaccine also in a first phase of experimentation, which demonstrated “potential to avoid COVID-19 disease” in humans.
With information from EFE