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
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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