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Safety, and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)

NCT05084989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2024-02-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Part1:Recombinant two-component COVID-19 vaccine (CHO cell)

2 doses. Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administration: Intramuscular (IM) injection

BIOLOGICAL

Part1: Placebo

2 doses. Before reconstitution: Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: Not Applicable; Does Volume: 0.5ml/dose; Routine of administration: IM injection;

BIOLOGICAL

Part2: Recombinant two-component COVID-19 vaccine (CHO cell)

1 dose.Before reconstitution:Lyophilized powder for reconstitution in single-use vials; After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter; Unite Does Strengths: 40ug/vial; Does Volume: 0.5ml/dose Routine of administrati

BIOLOGICAL

Part2: COVID-19 Vaccine, mRNA

1 dose. Intramuscular injection, 30 μg/0.3 mL.

Sponsors & Collaborators

  • Jiangsu Rec-Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • fanyue Meng · cdc jiangsu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-08-18
Completion
2023-02-09

Countries

  • Philippines

Study Locations

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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 NCT05084989 on ClinicalTrials.gov