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Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

NCT05930730 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2023-10-18

No results posted yet for this study

Summary

This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.

Conditions

  • Safety of a Single Dose of COMVIGEN Vaccine
  • Reactogenicity of a Single Dose of COMVIGEN Vaccine
  • Immunogenicity of a Single Dose of COMVIGEN Vaccine
  • Safety of a Single Dose of BIVALENT Pfizer/BNT Vaccine
  • Reactogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine
  • Immunogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine

Interventions

BIOLOGICAL

Comvigen (Bivalent, ChulaCov19 BNA159.2)

single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine

BIOLOGICAL

BIVALENT Pfizer/BNT vaccine

single dose of BIVALENT of Pfizer/BNT Bivalent vaccine at 30 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine

Sponsors & Collaborators

  • Chula Clinical Research Center (Chula CRC), Faculty of Medicine Chulalongkorn University, Bangkok, Thailand

    collaborator UNKNOWN

  • HIV-NAT, Thai Red Cross - AIDS Research Centre

    collaborator UNKNOWN

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Watsamon Jantarabenjakul, MD · Department of Pediatric, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  • Sivaporn Gatechompol, MD · HIVNAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Thailand

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 NCT05930730 on ClinicalTrials.gov