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Phase 1 and 2 Trial Methods for the BBIBP-CorV Vaccine

This study was a randomized, double-blinded, placebo-controlled, phase 11 and phase 22 trial conducted in Shangqiu City, China.

  • In phase 11 of the trial, healthy individuals who tested negative for antibodies against SARS-CoV-2 were placed into two age categories: one group for 1818 to 5959 year olds and another group for 6060 years and older. Each individual was then randomly administered a placebo or the vaccine (BBIBP-CorV). The placebo and vaccine were administered through a two-dose schedule on days 00 and 2828 of the trial in doses of either 22 μg, 44 μg, or 88 μg.

  • In phase 22 of the trial, healthy individuals ranging from 1818 to 5959 years of age were randomly administered either the vaccine or placebo. The placebo and vaccine were administered through a single-dose schedule on day 00 with 88 μg, or through a two-dose schedule on either days 00 and 1414, days 00 and 2121, or days 00 and 2828 in doses of 44 μg.

  • The primary outcomes for the trial were tolerability and safety. The secondary outcome was established as immunogenicity against SARS-CoV-2.

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Updated 2026-05-07

Tags

SARS-CoV-2 (COVID-19)

Biomedical Sciences