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An Investigator Initiated, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

NCT05679466 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2023-01-11

No results posted yet for this study

Summary

Study Objective(s) To evaluate the safety, immunogenicity and protective efficacy of 1 dose of ReCOV in participants who have received 2 or 3 doses of inactivated SARS-CoV-2 vaccination in Chinese adults aged 18 years and older.

Primary objective To demonstrate the safety within 30 days after booster dose. Secondary objective(s) To evaluate the immunogenicity after booster dose. To demonstrate the safety within 6 months after booster dose. To evaluate the protective efficacy of RT-PCR-confirmed SARS-CoV-2 infection and COVID-19 after booster dose.

Indications：Prevention of COVID-19 caused by SARS-CoV-2 Population：Participants aged 18 years and older who completed 2 or 3 doses vaccination of inactivated COVID-19 vaccines and whose last dose was given 6-18 months, of which the elderly aged 60 years and older account for about 10% to 15%.

Sample Size：Approximately 3,300 participants

Conditions

  • Prevention of COVID-19 Caused by SARS-CoV-2

Interventions

BIOLOGICAL

randomized, double-blinded, placebo-controlled

Approximately 3300 participants will be enrolled, including an immunogenic subgroup of approximately 240. Approximately 10% to 15% of all subjects will be 60 years of age and older. Enrolled subjects will be stratified by age (18-59 years, 60 years and older), number of previous doses of COVID-19 vaccine (2 or 3 doses), and interval from the last previous dose (180-365 days, 366-540 days). Participants will be randomized in a 1:1 ratio to receive 1 dose of the ReCOV or placebo on Day 0.

Sponsors & Collaborators

  • Yu Qin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-27
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT05679466 on ClinicalTrials.gov