A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study

Phase 2

Completed

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
MVC-COV1901(S protein with adjuvant)	MVC-COV1901(S protein with adjuvant)	S-2P protein with CpG and Aluminum Hydroxide/0.5mL

Primary Outcome Measures

Name	Time	Method
Number of Adverse Event (Safety of MVC-COV1901)	Day 1 to 28 days after second vaccination	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)
Percentage of Adverse Event (Safety of MVC-COV1901)	Day 1 to 28 days after second vaccination	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)
Immunogenicity of MVC-COV1901(Neutralizing Antibody)	Day 1 to 28 days after second vaccination	To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)	Day 1 to 180 days after second vaccination	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)
Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)	Day 1 to 180 days after second vaccination	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)
Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)	Day 1 to 28 days after second vaccination	To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention

Locations (11): Changhua Christian Hospital
🇨🇳
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳
Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳
Taichung, Taiwan
Chang-Guang Memorial Hospital Lin-Kou
🇨🇳
Taoyuan, Taiwan
National Cheng Kung University Hospital
🇨🇳
Tainan, Taiwan
Taipei Veteran General Hospital
🇨🇳
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
🇨🇳
Taipei, Taiwan
Taipei Medical University Hospital
🇨🇳
Taipei, Taiwan
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Tri-Service General Hospital
🇨🇳
Taipei, Taiwan
Tao-Yuan General Hospital
🇨🇳
Taoyuan, Taiwan