Researchers in China conducted a Phase 1/2 study demonstrating the safety, tolerability, and immunogenicity of a candidate vaccine for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This is the current Coronavirus Disease 2019 (COVID-19) pandemic.
In a randomized, double-blind, placebo-controlled trial, the inactivated SARS-CoV-2 vaccine, BBIBP-CorV, was tested in two age groups (18-59 and 60 years) in healthy individuals at all doses. It has been shown to be safe and tolerable. More than a year).
As reported in Lancet infectionA strong humoral immune response was observed in all vaccine recipients.
The trial, conducted by Xiaoming Yang (Beijing Institute of Bioproducts) and colleagues from various other institutions in China, was conducted at the Centers for Disease Control and Prevention in Liangyuan District, Shangqiu, Henan Province.
Yang et al. Reported that only mild side effects were observed and no serious side effects were reported in either age group.
“This is the first report of an inactivated SARS-CoV-2 vaccine tested in human participants,” the researchers say. “We may further investigate this inactivated vaccine for the control and prevention of COVID-19.”
Accelerated efforts to test vaccine candidates
Since the first case of SARS-CoV-2 was first identified in Wuhan, China at the end of last year, the virus has now infected more than 39.8 million people and killed more than 1.1 million people.
People over the age of 60, and those with underlying health conditions, are at a very high risk of serious illness and death after infection.
In the absence of a licensed vaccine to protect against SARS-CoV-2, an ongoing COVID-19 pandemic guarantees accelerated efforts to test vaccine candidates, Yang and colleagues say.
Testing of inactivated SARS-CoV-2 vaccine candidate BBIBP-CorV
The team conducted a dose-escalation, randomization, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and immunogenicity of the inactivated SARS-CoV-2 vaccine candidate BBIBP-CorV. Was carried out.
Eligible participants were healthy individuals aged 18-80 years who were negative for IgG antibodies to serum-specific immunoglobulin M (IgM) and SARS-CoV-2 prior to enrollment.
In Phase 1 of the study, 192 participants (mean age 53.7 years) should be divided into two age groups (18-59 years and 60 years and older) before receiving two doses of the BBIBP-CorV vaccine or placebo. Randomly assigned. Scheduled at 2 μg, 4 μg, or 8 μg on days 0 and 28 by intramuscular injection into the arm.
In Phase 2, participants aged 18-59 years (mean age 41.7 years) were randomly assigned to receive an intramuscular injection of vaccine or placebo on day 0 on a single or double dose schedule of 8 μg. I did. 4 μg on days 0 and 14, 0 and 21 or days 0 and 28.
The team reports that the BBIBP-CorV vaccine given as a two-dose vaccination is safe and tolerated in all three doses across both age groups. A strong humoral immune response was observed in all vaccine recipients.
Phase 1 findings
In Phase 1, at least one side effect occurred within the first 7 days among 42 of 144 vaccinated individuals. The most common systemic adverse reaction was fever.
Among patients aged 18 to 59 years, fever was observed in 1 from the 2 μg group, 1 from the 4 μg group, and 2 from the 8 μg group.
Of those over the age of 60, one in the 8 μg group had fever.
All side effects were mild or moderately severe and no serious adverse events were reported within 28 days after vaccination.
Neutralizing antibody titers were higher in vaccine recipients on day 42 than in placebo recipients across both age groups.
Phase 2 findings
In Phase 2, at least one side effect occurred within the first 7 days among 76 of the 336 vaccinated people.
At least one side effect occurred in 33 patients who received 8 μg on day 0. Eighteen patients who received 4 μg on days 0 and 14. Fifteen patients who received 4 μg on days 0 and 21. 10 patients who received 4 μg on days 0 and 28.
One placebo recipient who received 4 μg on days 0 and 21 reported grade 3 fever, which was self-limiting and participants recovered.
All other side effects were mild or moderately severe. The most common systemic reaction was fever, which occurred in one person receiving 8 μg on day 0. Persons who received 4 μg on days 0 and 14. Three patients who received 4 μg on days 0 and 21 and two patients who received 4 μg on days 0 and 28.
The vaccine-induced neutralizing antibody titer on day 28 was 8 μg once on day 0 between those who received 4 μg on day 0 and those who received it again on day 14, 21, or 28. It was significantly larger than those who received only.
Possibility of this vaccine
Yan et al. Show that the BBIBP-CorV vaccine is safe, tolerated, and immunogenic among healthy adults, whether under the age of 60 or over the age of 60. It says that it was.
“Immune with BBIBP-CorV will lead to rapid induction of the immune response to SARS-CoV-2 and will help prevent or limit the COVID-19 pandemic,” they write.
“Further clinical research is needed to assess the potential of this vaccine in clinical applications,” the team concludes.