By Fineline Cube China-based CanSino Biologics (HKG: 6185) has provided data updates from three clinical studies for its adenovirus type-5 vector-based COVID-19 vaccines. The studies assess the safety and immunogenicity of CanSino’s vaccines in various age groups and vaccination scenarios.
Study 1: Bivalent Inhaled Vaccine for Adults
The first study focused on CanSino’s bivalent inhaled recombinant novel coronavirus vaccine (adenovirus type-5 vector) targeting Omicron strains and variants in adults aged 18 and above. Initiated in September 2022 in Chongqing, the study enrolled 450 participants with long-term follow-up ongoing. The overall safety results indicated that CanSino’s inhaled recombinant vaccine used as a booster was safe, with no significant differences between groups receiving the vaccine. Neutralizing antibody levels were measured 28 days post-vaccination, showing GMTs of 245, 288, and 104 for the bivalent, original strain monovalent, and Omicron strain monovalent vaccine groups, respectively.
Study 2: Safety and Immunogenicity in Children and Adolescents
The second study assessed the safety and immunogenicity of Convidecia (recombinant novel coronavirus vaccine, adenovirus type 5 vector) and the inhaled recombinant novel coronavirus vaccine in children and adolescents aged 6 to 17 years. Launched in April 2022 in Beijing and Hunan, the trial enrolled 360 participants. The inhaled vaccine group showed a lower incidence of adverse reactions (15.91%) within 28 days post-immunization compared to the control group. Antibody levels in the inhaled vaccine group reached 4,967BAU/ml on day 28, significantly higher than both the intramuscular injection group (3,528BAU/ml) and the inactivated vaccine group (411BAU/ml).
Study 3: Booster Vaccination in Adults
The third study was a randomized, open, parallel-controlled trial assessing the immunogenicity and safety of the inhaled and intramuscular injection recombinant novel coronavirus vaccine (adenovirus type 5 vector) as a booster in adults aged 18 who had received three doses of inactivated vaccines. Conducted in Jiangsu, the study enrolled 360 participants. The inhaled vaccine group showed a lower incidence of adverse reactions (9.40%) within 28 days post-immunization, with no grade 3 adverse reactions or serious adverse events (SAEs) reported within 6 months. The inhaled vaccine group’s neutralizing antibody levels reached 672 on day 28 post-booster, higher than the intramuscular injection group (583) and significantly higher than the inactivated vaccine group (59).
Future Prospects and Strategic Implications
These clinical studies highlight CanSino Biologics’ commitment to developing safe and effective COVID-19 vaccines. The data from these trials support the potential use of CanSino’s inhaled vaccine as a booster, demonstrating strong immune responses and favorable safety profiles. This positions CanSino to contribute to global efforts in combating COVID-19 and its variants.-Fineline Info & Tech