COVID-19 Clinical Trial
Official title:
A Randomized, Blinded, Two-part, Phase II Trial to Evaluate the Safety and Immunogenicity of the Recombinant Two-component COVID-19 Vaccine (CHO Cell) in Adults 18 Years and Older
Part 1: Primary Vaccination in Adults Part 1 will evaluate the safety and immunogenicity of the recombinant two component COVID-19 vaccine (CHO cell) (ReCOV for short) in adults aged 18 years and older, when administered as 2 intramuscular doses, 21 days apart. Part 2: Booster Vaccination in Adults Part 2 will evaluate the immunogenicity and safety and of one booster dose of ReCOV in adult participants who have received primary vaccination with 2 doses of an inactivated COVID-19 vaccine (CoronaVac®). COMIRNATY®, an mRNA COVID-19 vaccine will be used as the active control.
Part 1: Primary Vaccination in Adults Around 340 participants aged 18 years and older who do not have known COVID-19 or COVID-19 vaccination history will be randomized into ReCOV group (40 μg) or placebo group in a ratio of 2:1. Accordingly, around 227 participants will receive 40 μg ReCOV and 113 participants will receive matching placebo, respectively. Participants will be stratified by age (18~59 years, ≥60 years) and status of SARS-CoV-2 antibody at baseline. After randomization, participants will enter into a double-blinded period (until all participants complete V6) and an open-label long-term follow-up period (after all participants complete V6 until end of the study). After all participants complete the visit at 7 days after the 2nd vaccination, the safety and reactogenicity data will be summarized by an independent statistic group, while the sponsor, investigators and all study participants will be kept blinded. The safety summary will be submitted to DSMB for review and recommendation on the initiation of Part 2. The primary analysis of Part 1 is planned after all participants complete the Visit 6 (V3 + 28 days, +7 days) and are unblinded, to evaluate the safety and immunogenicity during the double-blinded period. The final analysis of Part 1 will be conducted after all participants of the ReCOV group complete the follow-up visit at 6 months after the 2nd vaccination, to evaluate the safety and immunogenicity during this study stage. Part 2: Booster Vaccination in Adults This study part will enroll participants who have received primary vaccination by an inactivated COVID-19 vaccine (CoronaVac®) within 3 to 12 months (90~365 days). The mRNA COVID-19 vaccine, COMIRNATY ®, will be used as the active control. The immunogenicity induced by the booster vaccination of ReCOV (commercial batch, Lot# TC202205002) will be compared with that of COMIRNATY®. In addition, the immunogenicity of one dose booster of commercial batch ReCOV (Lot# TC202205002) will be compared with that of pilot batch ReCOV (Lot# HA202107009). About 600 participants will be enrolled into the study. Eligible participants will be 1:1:1 randomized to receive 20 μg ReCOV (Lot# HA202107009), 20 μg ReCOV (Lot# TC202205002), or 30 μg COMIRNATY®, stratified by age (18~59 years, ≥60 years) and the duration since the last primary vaccination (90~180 days, 181~365 days). All participants will be followed up for safety and reactogenicity. Participants will be observed for 30 minutes at study site after the vaccination. Before leaving the study site, participants will be given participant diaries to record solicited AEs within 7 days after dosing, and unsolicited AEs within 28 days after dosing. The occurrence of SAEs and AESIs will also be monitored till 6 months after the study vaccination. The interim analysis is planned after all participants complete the Visit 5 at 28 days after the dosing, to evaluate the immunogenicity and safety within this period. The final analysis will be conducted after all participants complete the follow-up visit at 6 months post the booster vaccination, to evaluate the immunogenicity and safety. ;
| 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 |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
| Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
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 |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
| Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
| Active, not recruiting |
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 | |
| 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 | |
| Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
| 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
|