They presented preliminary findings from a phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose administered on day 28.
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https://www.sciencedirect.com/science/article/pii/S1473309921000700 |
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8 March 2021, The Lancet Infectious Disease |
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Vaccine Safety |
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Double-blind, randomised control trial (RCT) |
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India |
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LEVEL I: RCT |
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They presented preliminary findings from a phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose administered on day 28. |
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At nine hospitals in India, the researchers conducted a double-blind, randomised, multicentre, phase 2 clinical trial to assess the immunogenicity and safety of BBV152 in healthy adults and adolescents (aged 12–65 years).
They present preliminary results of immunogenicity and safety studies on BBV152 in 380 vaccinated adults and adolescents. BBV152 stimulated immune responses and induced Th1-biased T-cell responses. |
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The 3-month post-second-dose GMTs (MNT50) in the phase 1 trial were 39.9 (95% CI 32·0–49·9) in the 3g with Algel-IMDG group, 69.5 in the 6 g with Algel group, 53.3 in the 6 g with Algel group, and 20.7 in the Algel alone group. |
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BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 g or 6 g) formulated with an alum-adsorbed toll-like receptor 7/8 agonist molecule (IMDG) (Algel).
BBV152 induced high neutralising antibody responses in the phase 1 trial, which remained elevated 3 months after the second vaccination in all participants. In comparison to the phase 1 trial, BBV152 demonstrated improved reactogenicity and safety outcomes, as well as enhanced humoral and cell-mediated immune responses in the phase 2 trial. The 6 g formulation with Algel-IMDG has been chosen for the phase 3 efficacy trial. Overall participant retention rates in the 3 g with Algel-IMDG group were 97%, and in the 6 g with Algel-IMDG group were 93 %. |