A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults

Summary

The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin, the immunogenicity against the VoCs, the antigen specific cellular immune response, as well as the potential efficacy of study intervention in preventing COVID-19.

Timeline

Start

2021-09-30

Primary completion

2021-10-08

Completion

2023-01-10

Outcome

Missed primary endpoint

paper The neutralizing antibodies on Day 15 and the anti-SARS-CoV-2 IgG titers on Day 15 and 29 of homologous mRNA-1273 were significantly higher than those of heterologous mRNA-1273/MVC-COV1901. PMID 37321955 ↗

paper Our results show that heterologous boost with MVC-COV1901 yielded an inferior immunogenicity but significantly fewer adverse events, compared with homologous boost with mRNA-1273. PMID 37321955 ↗

Publications

• Huang ST, Huang YS, Liu WD, Pan SC, Sun HY, Lien CE, Chen C, Hsieh SM. Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. J Formos Med Assoc. 2023 Nov;122(11):1165-1173. doi: 10.1016/j.jfma.2023.05.030. Epub 2023 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MVC-COV1901	Vaccine	—	—
Subject	mRNA-1273	Messenger RNA (mRNA)	—	—

Indications

No indication recorded.