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The Immune Response of Heterologous Boost Third Dose of mRNA and Protein COVID-19 Vaccine

NCT05132855 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2022-07-25

No results posted yet for this study

Summary

The severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific antibody and neutralizing antibody level induced by adenovirus vector vaccines were lower than mRNA vaccines. Vaccine efficacy of ChAdOx1 nCoV-19 was lower than BNT162b2 and mRNA 1273 in clinical trials. The emergence of highly transmissible and mutant variants of SARS-COV-2 has raised the concern of COVID-19 vaccine effectiveness. The complete vaccination rate is still low in Taiwan. Strict border control measures are imposed by Central Epidemic Command Center. However, the measure of quarantine for flight crew is considered one of the breach of COVID-19 infection control. Despite most of the flight crew has fully vaccinated, several episodes of breakthrough infection occurred among flight crew resulting in domestic infection recently. Low neutralizing antibody was found in a proportion of fully vaccinated flight crew and healthcare workers. A 3rd booster COVID-19 dose is considered for flight crew and healthcare workers. This study is to determine the safety, reactogenicity, and immunogenicity of heterologous 3rd booster of mRNA and protein COVID-19 vaccines.

Conditions

Interventions

BIOLOGICAL

BNT162b2

BNT162b2 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA.

BIOLOGICAL

mRNA-1273

mRNA-1273 is an mRNA vaccine to prevent COVID-19 infection and is approved by the emergency use of authorization (EUA) by the Taiwan FDA.

BIOLOGICAL

MVC-COV1901

MCV COVID-19 vaccine is a protein subunit vaccine containing S2P S-protein which passes the EUA by Taiwan FDA.

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    collaborator INDUSTRY

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Cheng-Hsun Chiu, MD, PhD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT05132855 on ClinicalTrials.gov