A Phase 2 interventional study of Half dose of MVC-COV1901 and Full dose of MVC-COV1901 in COVID-19 Vaccine, sponsored by Medigen Vaccine Biologics Corp.. Completed at 4 sites in Taiwan. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Medigen Vaccine Biologics Corp. · Phase 2, Interventional, and Prevention
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:
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.
Medigen Vaccine Biologics Corp. is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Female participants must:
i.Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.Have a negative pregnancy test
Exclusion Criteria:
Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint.
Acute diseases or serious medical conditions include cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant.
7.5 mcg of S-2P protein with adjuvant
Biological: Half dose of MVC-COV1901
15 mcg of S-2P protein with adjuvant
Biological: Full dose of MVC-COV1901
5\*10\^10 viral particles of AZD1222
Biological: AZD1222
50 mcg mRNA encoding the pre-fusion stabilized S protein
Biological: Half dose of mRNA-1273
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.
Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.
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
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
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ChAdOx1 nCoV-19
Medigen Vaccine Biologics Corp.