drugset / Trial / NCT05396573

A Phase 1b Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine Against COVID-19

NCT05396573

RandomizedParallel-groupDouble-blindPrevention

Summary

This is a phase 1b, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013 in healthy adults primed with a two-dose inactivated vaccine 6-9 months earlier. The study vaccine is administered IM in the upper arm deltoid as single booster shot on day 0.

Timeline

Start
2022-07
Primary completion
2022-08
Completion
2023-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator BNT162b2 Messenger RNA (mRNA) 30 ug
Subject RQ3013 Messenger RNA (mRNA) 30 ug Intramuscular
Subject RQ3013 Messenger RNA (mRNA) 60 ug Intramuscular

Indications