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

NCT05939596 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • AIM Vaccine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • fan zhang · AIM Vaccine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2023-09-28
Completion
2024-08-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939596 on ClinicalTrials.gov