NCT05394012

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

Randomized, Blinded, Positive Control Phase 1a Trial to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Chimera Vaccine (RQ3013) in Healthy Adults Aged 18-59 Years

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Walvax Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a phase Ⅰa, randomized, double-blind, positive control trial in healthy adults, intended to evaluate the safety and immunogenicity profile of RQ3013. The study vaccine is administered IM at upper arm deltoid as a two-dose primary series on day 0, 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	RQ3013	Two doses of 30 μg/0.15 mL at an interval of 28 days, or two doses of 60 μg/0.3 mL at an interval of 28 days
BIOLOGICAL	Comirnaty	Two doses of 30 μg/0.3 mL at an interval of 28 days

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-02-01
• Completion: 2023-06-01
• First posted: 2022-05-27
• Last updated: 2022-11-18