The Lancet Publishes Data of Phase I/II Clinical Trial for CNBG Beijing Institute’s COVID-19 Vaccine
The international medical journal The Lancet published an article titled “Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBIBP-CorV: a Randomised, Double-blind, Placebo-controlled, Phase 1/2 Trial,” revealing the results of the phase-I/II clinical trials of the inactivated coronavirus vaccine jointly developed by Beijing Institute of Biological Products Co., Ltd. under China National Biotec Group (CNBG) affiliated to Sinopharm and the Chinese Center for Disease Control and Prevention (China CDC). This marked another publication of data on inactivated coronavirus vaccine clinical trials by CNBG since its Wuhan Institute of Biological Products Co., Ltd. became the first in the world to publish data on relevant clinical trials in The Journal of the American Medical Association.
The research project, co-headed by Yang Xiaoming, chief scientist of the 863 Program under the Ministry of Science and Technology and chairman of CNBG, and Xia Shengli, chief physician at Henan Provincial Center for Disease Control and Prevention (Henan CDC), is jointly completed by several institutions including the Beijing institute of CNBG, Henan CDC, National Institutes for Food and Drug Control, and China CDC. Yang Xiaoming and Professor Guo Wanshen are both the correspondent authors of the paper, and Xia
Shengli and Dr. Zhang Yuntao and researcher Wang Hui are its first authors.
▲A screen shot of the research results published on the website of The Lancet.
This paper is based on a randomized, double-blind, and placebo-controlled experiment. In phase 1, 192 participants were randomly assigned to receive vaccine in low, mild and high volumes for both age groups (18-59 years and ≥60 years). Participants within each cohort were randomly allocated (3:1) to receive vaccine or placebo. In phase 2, 448 healthy adults (aged 18-59 years) were randomly assigned (1:1:1:1) to receive vaccine or placebo on a single-dose schedule of 8μg on day 0 or on a two-dose schedule of 4μg on days 0 and 14, 0 and 21, or 0 and 28. The primary outcomes were safety and tolerability. The secondary outcome was immunogenicity, assessed as the neutralizing antibody responses against infectious SARS-CoV-2.
Satisfying Immunogenicity by Effectively Inducing Neutralizing Antibodies
Research on candidate vaccines shows that in phase 1, the seroconversion rate of healthy adults who received low and mild doses reached 100% on day 14, while that of those receiving high doses reached 96%. For the age group ≥60 years, the seroconversion rate reached 100% on day 28. The neutralizing antibodies in all vaccine recipients evidently grew since day 7, and peaked on day 42. The valence of neutralizing antibodies in those receiving high doses of vaccines was obviously higher than that of those receiving low doses, but there were no evident differences from that of those receiving mild doses. In addition, the neutralizing antibodies induced by the vaccine can neutralize various kinds of strains, including natural variants with spike mutant (D614G). The phase II clinical trial indicated that neutralizing antibodies began to increase from day 14 to day 28 after the second vaccination in both D0/D14 and D0/D21 procedures. However, the titer of neutralizing antibodies induced by D0/D21 vaccination was evidently higher than the valence of neutralizing antibodies induced by D0/D14 vaccination.
This showed that the vaccine can effectively induce neutralizing antibodies in people of all age groups, at a level comparable to that of other similar vaccines under development, indicating its good immunogenicity
Within the first seven days after two-dose inoculation, adverse reactions were reported in 42 people (30% of all vaccine recipients). The most common adverse reaction was pain and then fever, but all were mild and self-limited, without the need of any medical treatment. No serious adverse event was reported in the clinical trials. Pain was reported in 34 (24%) of the vaccine recipients, and fever reported in five people (5%).
In terms of adverse reaction incidence, there was no significant difference between vaccine recipients and placebo recipients. Moreover, the adverse reaction incidence of the vaccine is lower than the average level of similar vaccines under clinical trials, testifying to the high safety of this inactivated vaccine.
Phase-III Clinical Trial Well Underway
On April 27, 2020, the inactivated coronavirus vaccine developed by Beijing Institute of Biological Products Co., Ltd. was approved by the National Medical Products Administration of China for phase-I/II clinical trials.
At present, the two inactivated vaccines for COVID-19 developed by CNBG’s Beijing and Wuhan institute have been under phase-III clinical trials in countries including the UAE, Bahrain, Egypt, Morocco, Peru and Argentina. The clinical trials are now well underway, with the inoculated sample population covering 125 countries. Currently, the results of the trials lead the world in all aspects.