Concept

Study design and participants: Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial

508 healthy participants between the ages of 18 and 60 years old were chosen via online recruitment with written formal consent and various other criteria for a randomized, double blind, placebo controlled clinical trial. Participants were eligible for the study based on age, having tested HIV negative, and having negative serum antibodies for COVID-19. Candidates were excluded based off of various factors like allergies, history of seizures, poorly controlled chronic illness, pregnancy, heart disease, a history of SARS infection and other factors. The participants were divided into 3 groups. 253 were assigned to the high dose group of 1e11 vp/mL, 129 to the low dose group of 5e10 vp/mL, and 126 to the placebo group. These groups were organized based on randomization number assigned to each participant and vaccines, such that each participant was given the vaccine matching their assigned numbers, and a chosen ratio of 2:1:1.

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Updated 2020-12-22

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SARS-CoV-2 (COVID-19)

Biomedical Sciences