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

NCT05323435 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Recombinant two-component COVID-19 vaccine (CHO cell)

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

BIOLOGICAL

COVID-19 Vaccine (Vero Cell), Inactivated

Milky-white suspension.Stratified precipitate may form which can be dispersed by shaking

Sponsors & Collaborators

  • Jiangsu Rec-Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Suad Al Hannawi, Dr. · AI Kuwait Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2022-07-05
Completion
2023-01-16

Countries

  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases

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 NCT05323435 on ClinicalTrials.gov