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

NCT05394012 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-11-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Shanghai RNACure Biopharma Co., Ltd.

    collaborator UNKNOWN

  • Walvax Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lin Yuan · Walvax Biotechnology Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-02-28
Completion
2023-06-30

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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 NCT05394012 on ClinicalTrials.gov