Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05323435

Immunogenicity and Safety Study of Recombinant Two-Component COVID-19 Vaccine (CHO Cell)(ReCOV)

COVID-19 Clinical Trial

Official title:
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Phase II Study to Evaluate the Immunogenicity and Safety of One Dose Booster by Recombinant Two-Component COVID-19 Vaccine (CHO Cell) in Adults Aged 18 Years and Older

Clinical Trial Summary

This is a multicenter, randomized, observer-blinded, active-controlled Phase II study to evaluate the immunogenicity, safety and reactogenicity of the low dose (20μg) and high dose (40μg) of ReCOV, when administered as a booster to healthy adults aged 18 to 65 years who have completed two or three doses vaccination (prioritized two doses). Estimate 300 participants.

Clinical Trial Description

The study is a multicenter, randomized, observer-blinded, active-controlled trial. About 300 eligible participants will be randomized equally (1:1:1) into 20 μg ReCOV group, 40 μg ReCOV group, and the control vaccine [COVID-19 Vaccine (Vero Cell), Inactivated] group, respectively, stratified by age (18 to < 50 years, ≥ 50 to ≤ 65 years) and the duration since the last dose of primary vaccination (90~180 days, 181~365 days). All Participants will be observed for 30 minutes after study vaccination at study site if Participants will be asked to record solicited AEs within 7 days and unsolicited AEs within28 days. After 28 days post the study vaccination，all participants will have 2 on-site safety follow-up Visits on Day 90 (±15days) and on Day 180 (±15days) after the study vaccination to collect serious adverse evens (SAEs), adverse events of special interest (AESIs). During the study period, they can spontaneously report any adverse events (AEs) they experienced at any time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05323435
Study type Interventional
Source Jiangsu Rec-Biotechnology Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date May 30, 2022
Completion date January 16, 2023
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure