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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
MVC-COV1901 vaccine after a 3-month Interval
MVC-COV1901 vaccine after a 6-month Interval
Taoyuan General Hospital
Taoyuan, Taiwan
RECRUITINGPrimary Immunogenicity
To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in 3 months, compared to 6 months, in terms of neutralizing antibody Geometric Mean Titers (GMT)
Time frame: Day1 to 28 days after vaccination
Primary Safety
To evaluate the safety and tolerability of heterologous third-boost (MVC-COV1901) from Day 1 to 28 days after the study intervention The number and percentage of participants with the occurrence of: * Solicited local adverse events (AEs) * Solicited systemic AEs * Unsolicited AEs
Time frame: Day1 to 28 days after vaccination
Secondary Immunogenicity
To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers GMT
Time frame: Day 1 and Day 169
Secondary Safety
To evaluate the safety of heterologous third-boost (MVC-COV1901), over the study period The number and percentage of participants with the occurrence of: * MAAEs * AESIs * VAED * SAEs
Time frame: Day 1 to Day169
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