Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial.

ABSTRACT: This randomized, double-blind, placebo-controlled phase 1/2 trial aimed at evaluating the safety and immunogenicity of Ad5-nCoV via aerosolized or intramuscular or intramuscular-aerosolized routes in SARS-CoV-2-negative adults aged over 18 years. In the phase 1 trial, participants were sequentially enrolled into one of five regimen cohorts: Low-Dose (two doses of aerosolized Ad5-nCoV with 0.5 × 10¹⁰ viral particles [vps] per dose), Middle-Dose (two doses of aerosolized Ad5-nCoV with 1.0 × 10¹⁰ vps per dose), High-Dose (two doses of aerosolized Ad5-nCoV with 2.0 × 10¹⁰ vps per dose), Mixed (intramuscular Ad5-nCoV with 5.0 × 10¹⁰ vps [first dose] and aerosolized Ad5-nCoV with 2.0 × 10¹⁰ vps [second dose]), and Single-Dose (one dose of ae

SUBMITTER: Zhu Y 

PROVIDER: S-EPMC10975308 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature