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A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19

NCT05097053 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-12-23

No results posted yet for this study

Summary

This primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants in order to demonstrate the immunogenicity and safety of heterologous third-boost with MVC-COV1901, in terms of the neutralizing antibody GMTs at 28 days after the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin as well as the potential efficacy of study intervention in preventing COVID-19. This study is aimed to recruit participants at single study site in Northern Taiwan.

Conditions

  • COVID-19 Vaccine

Interventions

BIOLOGICAL

MVC-COV1901(3 Months)

MVC-COV1901 vaccine after a 3-month Interval

BIOLOGICAL

MVC-COV1901(6 Months)

MVC-COV1901 vaccine after a 6-month Interval

Sponsors & Collaborators

  • Medigen Vaccine Biologics Corp.

    collaborator INDUSTRY

  • Taoyuan General Hospital

    lead OTHER_GOV

Principal Investigators

  • Chieh-Yu Cheng, MD.PhD. · Taoyuan General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2022-03-31
Completion
2022-07-31

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 NCT05097053 on ClinicalTrials.gov