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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
804
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.
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.
Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Incidence of Adverse Events from Day 1 to 28
To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose. * Solicited local adverse events (AEs) (up to 7 days after injection of booster dose) * Solicited systemic AEs (up to 7 days after injection of booster dose) * Unsolicited AEs (up to 28 days after injection of booster dose) * AE of special interest (AESI) * Vaccine-associated enhanced disease (VAED) * Serious adverse event (SAE)
Time frame: Day1 to 28 days after vaccination
Primary Immunogenicity-1
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT
Time frame: Day1 to Day 29
Primary Immunogenicity-2
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • Seroconversion rate (SCR)
Time frame: Day1 to Day 29
Primary Immunogenicity-3
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT ratio
Time frame: Day1 to Day 29
Primary Immunogenicity-4
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • Seroresponse rate
Time frame: Day1 to Day 29
Incidence of Adverse Events from Day 1 to 181
To measure the incidence of adverse event throughout the whole study period. * ≥ Grade 3 AE * AESI * VAED * SAE
Time frame: Day 1 to Day 181
Secondary Immunogenicity (Humoral)-1
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Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
To evaluate the immunogenicity in terms of Anti-spike IgG • GMT
Time frame: Day 1 to Day 181
Secondary Immunogenicity (Humoral)-2
To evaluate the immunogenicity in terms of Anti-spike IgG • SCR
Time frame: Day 1 to Day 181
Secondary Immunogenicity (Humoral)-3
To evaluate the immunogenicity in terms of Anti-spike IgG • GMT ratio
Time frame: Day 1 to Day 181
Secondary Immunogenicity (Cellular)
To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot)
Time frame: Day 1 to Day 15