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

NCT05396573 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-05-31

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

RQ3013

A single dose of 30 μg/0.15 mL, a single dose of 60 μg/0.3 mL

BIOLOGICAL

Comirnaty

A single dose of 30 μg/0.3 mL

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2022-08-31
Completion
2023-07-31

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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 NCT05396573 on ClinicalTrials.gov