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

NCT05079633 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-03-22

No results posted yet for this study

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.

Conditions

  • Covid19 Vaccine

Interventions

BIOLOGICAL

Homologous boost schedule

1st dose mRNA 1273 , 2nd dose mRNA 1273

BIOLOGICAL

Heterologous boost schedule

1st dose mRNA 1273 , 2nd dose MVC COV1901

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Szu-Min Hsieh, MD.Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2021-10-08
Completion
2023-01-10

Countries

  • Taiwan

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 NCT05079633 on ClinicalTrials.gov