NCT05939596

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021)

Randomized, Blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) in Participants Aged 18 Years and Older Who Have Received SARS-CoV-2 Vaccine

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AIM Vaccine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial is a phase I clinical trial of a SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial used a randomized, blinded, placebo-controlled design to evaluate the safety, tolerability, and preliminary immunogenicity of the trial vaccine in participants Aged 18 Years and Older who had received SARS-CoV-2 Vaccine.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Bivalent mRNA Vaccine	100 μg /1.0 mL/dose, slightly milky white and clear liquid, intramuscular injection into the lateral deltoid muscle of the upper arm.
OTHER	Saline	100 μg /1.0 mL/dose, intramuscular injection into the lateral deltoid muscle of the upper arm.

Timeline

• Start date: 2023-08-10
• Primary completion: 2023-09-28
• Completion: 2024-08-25
• First posted: 2023-07-11
• Last updated: 2023-11-22

Locations

1 site across 1 country: China