A Phase 2 interventional study of MVC-COV1901(S protein with adjuvant) in Covid19 Vaccine, sponsored by Medigen Vaccine Biologics Corp.. Completed at 11 sites in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Medigen Vaccine Biologics Corp. · Phase 2, Interventional, and Prevention
The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21
This is an extension study of the main study CT-COV-21, "A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901."
This extension study is a prospective, open-label, multicenter study. In this extension study, approximately 500 participants who received the placebo and have remained blinded in the main study until Day 119 (90 days after the second vaccination of the main study) are enrolled and receive MVC-COV1901. Each participant will receive 2 doses of MVC-COV1901, administered 28 days apart via IM injection in the deltoid region, preferably of the non-dominant arm, at Day 1 and Day 29.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 274 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Medigen Vaccine Biologics Corp. is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female participant 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
Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) directly involved in the conduct of the study.
Prior/Concomitant Therapy
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Biological: MVC-COV1901(S protein with adjuvant)
Approximately 500 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
Number of Adverse Event (Safety of MVC-COV1901)
To evaluate the safety and tolerability of MVC-COV1901 from Day 1 to 28 days after the second dose of study intervention in terms of the number of participants with the occurrence of: * Solicited local AEs (up to 7 days after each dose of study intervention) * Solicited systemic AEs (up to 7 days after each dose of study intervention) * Unsolicited AEs (up to 28 days after each dose of study intervention) * AE of Special Interest (AESI) * Vaccine-Associated Enhanced Disease(VAED) * Serious adverse events (SAEs)
Time frame: Day 1 to 28 days after second vaccination
Percentage of Adverse Event (Safety of MVC-COV1901)
To evaluate the safety and tolerability of MVC-COV1901 from Day 1 to 28 days after the second dose of study intervention in terms of the percentage of participants with the occurrence of: * Solicited local AEs (up to 7 days after each dose of study intervention) * Solicited systemic AEs (up to 7 days after each dose of study intervention) * Unsolicited AEs (up to 28 days after each dose of study intervention) * AE of Special Interest (AESI) * Vaccine-Associated Enhanced Disease(VAED) * Serious adverse events (SAEs)
Time frame: Day 1 to 28 days after second vaccination
Immunogenicity of MVC-COV1901(Neutralizing Antibody)
To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention
Time frame: Day 1 to 28 days after second vaccination
Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
To evaluate the safety of MVC-COV1901 over the study period in terms of the number of participants with the occurrence of: * \>= Grade 3 AE * AE of Special Interest (AESI) * Vaccine-Associated Enhanced Disease(VAED) * Serious adverse events (SAEs)
Time frame: Day 1 to 180 days after second vaccination
Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
To evaluate the safety of MVC-COV1901 over the study period in terms of the percentage of participants with the occurrence of: * \>= Grade 3 AE * AE of Special Interest (AESI) * Vaccine-Associated Enhanced Disease(VAED) * Serious adverse events (SAEs)
Time frame: Day 1 to 180 days after second vaccination
Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)
To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention
Time frame: Day 1 to 28 days after second vaccination
Incidence of confirmed COVID-19 cases (Efficacy of MVC-COV1901)
To estimate the efficacy of MVC-COV1901, as compared to placebo, in the prevention of COVID-19 in terms of : * The number of laboratory-confirmed COVID-19 cases occurring ≥ 15 days after any dose of study intervention. * The number of laboratory-confirmed COVID-19 severe cases occurring ≥ 15 days after any dose of study intervention.
Time frame: Day 1 to 180 days after second vaccination
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medigen Vaccine Biologics Corp.