A vaccine targeting COVID-19 out of China called BBIBP-CorV, an inactivated SARS-CoV-2 vaccine, is safe and well-tolerated at all tested doses in two age groups, as reported recently in The Lancet Infectious Diseases. Involving participants between 18 and 80, this study revealed that the antibody responses were induced in all recipients of the BBIBP-CorV vaccine candidate.
Associated with the news, study author Xiaoming Yang with the Beijing Institute of Biological Products Company Limited China reported, “Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease.”
The results were derived from an early stage Phase 1/2 study investigating the safety, efficacy, and immunogenicity in 540 healthy Chinese volunteers, including 96 elderly participants. The sponsor reported all participants seroconverted, and any reported adverse events or side effects were “mild.”
Current COVID-19 Vaccine Situation
There are currently 42 vaccines for COVID-19 in clinical trials, as reported by the authors recently. These vary in type and include DNA plasmid vaccines, inactivated virus vaccines, adenovirus-vectored vaccines, RNA vaccines, protein subunit vaccines, and virus-like particle vaccines. Some of these have already been shown to be safe and elicit immune responses in early phase clinical trials. For a current update on the World Health Organization (WHO) “Draft Landscape of COVID-19 Candidate Vaccines,” see the link.
Who is Beijing Institute of Biological Products Company Limited China?
As TrialSite has reported, this group is part of a holding company called China National Biotech Group Company Limited.
Clinical Trial Sponsors & Funders
This study was carried out by researchers from the Henan Provincial Center for Disease Control and Prevention (China), The Beijing Institute of Biological Products (China), the Chinese Center for Disease Control and Prevention (China), The National Institute for Food and Drug Control (China), Tsinghua University (China), and Beijing Zhongsheng Hengyi Pharmaceutical Technology (China). It was funded by the National Program on Key Research Project of China, National Mega Projects of China for Major Infectious Diseases, National Mega Projects of China for New Drug Creation, and the Beijing Science and Technology Plan.
The Vaccine Candidate
The BBIBP-CorV vaccine used in the study reported here is based on a sample of the virus that was isolated from a patient in China. Stocks of the virus were grown in the lab using cell lines and then inactivated using a chemical called beta-proprionolactone. BBIBP-CorV includes the killed virus mixed with another component, aluminum hydroxide, which is called an adjuvant because it is known to boost immune responses.
The authors reported that the study did include limitations: such as the short duration of follow-up at only 42 days. The study precluded children and adolescents under 18.
Third-Party Comment from Russia
Professor Larisa Rudenko, with the Institute of Experimental Medicine, Saint Petersburg, reported in a linked Comment article that there are additional studies necessary to better understand if inactivated SARS-CoV-2 investigational vaccines can induce and maintain virus-specific T -cell responses; as she emphasizes optimal antibody responses need CD4-positive T-cell help, in addition to cytotoxic CD8-positive T-cell activation and of course are all vital for viral clearance should “ neutralizing antibody-mediated protection is incomplete.”