drugset / Trial / NCT05132855

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

NCT05132855

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2021-11-30
Primary completion
2023-04
Completion
2023-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT162b2 Messenger RNA (mRNA) 30 ug
Subject Elasomeran Messenger RNA (mRNA) 50 ug
Subject Elasomeran Messenger RNA (mRNA) 100 ug
Subject MVC-COV1901 Vaccine 15 ug

Indications