The purpose of this study is to assess the safety, tolerability, and immunogenicity of a 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 duration will be 1 day. -The visit frequency will be 6 on-site visits (1 screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.
This is a Phase I, prospective, randomized, open-labeled study to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with the MVC-COV1901 or MVC1901(Beta). Approximately 120 participants aged ≥18 and \<55 years, who received two or three doses of MVC- COV1901 vaccines, will be enrolled and divided into two groups. Each group will consist of approximately 60 eligible subjects, and for each group the randomization will be stratified based on site to three treatment arms (15 mcg of MVC-COV1901 or 15 mcg or 25 mcg of MVC-COV1901(Beta) in 1:1:1 ratio).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
107
Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region. Group A and B
Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-15 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region
Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-25 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region
Taipei Medical University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Incidence of Adverse Events from Day 1 to 29
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: Day 1 to Day 29
Primary Immunogenicity-1
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT
Time frame: Day 1 to Day 29
Primary Immunogenicity-2
To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT ratio
Time frame: Day 1 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
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 • 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 91
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