NCT05097053

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

A Parallel Group, Prospective, Randomized, Two-arm, Open-label Study to Evaluate the Immunogenicity, Safety, and Tolerability of Heterologous 3rd Boost of MVC-COV1901 in Adults With 2 Doses of ChAdOx1-nCov-19 in 3 Months and 6 Months

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Taoyuan General Hospital · Other Government
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

This a parallel group, prospective, randomized, two-arm, open-label, single-center study to be conducted in approximately 200 healthy participants aged 20 to 64 years who have had their two doses of ChAdOx1-nCov-19 (Astra Zeneca). Preparation and administration of study intervention will be performed by authorized unblinded site personnel. Eligible participants will receive MVC-COV1901 vaccine after a 3-month (Group A: \< 16 weeks and ≥ 12 weeks) or 6-month (Group B: \< 28 weeks and ≥ 24 weeks) interval apart from their second dose of ChAdOx1-nCov-19. The study consists of 6 on-site visits: * Day -28 to Day 1, Visit 1 (Screening) * Day 1, Visit 2 (study intervention) : randomization Group A and B Group A: * Day 1, Visit 2: treatment * Day 29 ± 3 days, Visit 3 * Day 85 ± 3 days, Visit 4 * Day 169 ± 3 days, Visit 5 Group B: * Day 1, Visit 2 * Day 85 ± 3 days, Visit 3: treatment * Day 113 ± 3 days, Visit 4 * Day 169 ± 3 days, Visit 5

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-07
• Primary completion: 2022-03-01
• Completion: 2022-07-01
• First posted: 2021-10-27
• Last updated: 2021-12-23

Locations

1 site across 1 country: Taiwan