NCT05197153

A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19

A Phase II, Prospective, Randomized, Observer-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Heterologous Booster Dose With AZD1222, mRNA-1273, or MVC-COV1901 COVID-19 Vaccine in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include: * The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up). * The treatment will include 1 booster dose only. * The visit frequency will be 6 on-site visits and 1 phone visit.

Detailed description

This is a Phase II, prospective, randomized, observer-blinded, multi-center study, to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with AZD1222, mRNA-1273, or MVC-COV1901 vaccine. Approximately 960 participants aged 18 \~ \< 80 years, who received homologous two doses of vaccines 150 \~ 365 days ago, will be enrolled and divided into three groups. Each group will consist of 320 eligible subjects, and for each group the randomization will be stratified according to study site and age to four treatments (AZD1222, half dose of mRNA-1273, full dose or half dose of MVC-COV1901 in 1:1:1:1 ratio). Therefore, within a group, for either age stratum, there will be at least 30 participants for each treatment.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Half dose of MVC-COV1901	Approximately 240 participants will receive 1 doses of half of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
BIOLOGICAL	Full dose of MVC-COV1901	Approximately 240 participants will receive 1 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
BIOLOGICAL	AZD1222	Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
BIOLOGICAL	Half dose of mRNA-1273	Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

Timeline

• Start date: 2022-01-22
• Primary completion: 2022-06-01
• Completion: 2022-10-28
• First posted: 2022-01-19
• Last updated: 2023-03-15

Locations

4 sites across 1 country: Taiwan