Alliance for Pandemic Preparedness

July 24, 2020

Safety and Immunogenicity of the ChAdOx1 NCoV-19 Vaccine against SARS-CoV-2: A Preliminary Report of a Phase 1/2, Single-Blind, Randomised Controlled Trial

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  • Folegatti present preliminary results of a phase 1/2 single-blind, randomized multi-center (5 UK sites) trial of chimpanzee adenovirus-vectored vaccine expressing the SARS-CoV-2 spike protein (n=543 treatment and n=534). Controls received a meningococcal conjugate vaccine. Adverse effects were more common in the treatment arm and included included pain, fever, chills, muscle ache, and malaise. No serious adverse events were reported. Cell-mediated immunity peaked on day 14, and humoral (antibody) response rose by day 28 and was boosted by following a second dose in 10 participants assigned (non-randomly) to an unblinded boost group. Neutralizing antibody response was detected in all participants and was strongly associated with antibody levels.  

Folegatti et al. (July 2020). Safety and Immunogenicity of the ChAdOx1 NCoV-19 Vaccine against SARS-CoV-2: A Preliminary Report of a Phase 1/2, Single-Blind, Randomised Controlled Trial. The Lancet. https://doi.org/10.1016/S0140-6736(20)31604-4