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

NCT ID: NCT05048849

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2022-04-12

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.

Conditions

Covid19 Vaccine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MVC-COV1901(S protein with adjuvant)

S-2P protein with CpG and Aluminum Hydroxide/0.5mL

Group Type: EXPERIMENTAL

MVC-COV1901(S protein with adjuvant)

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Participants who are in the placebo arm of the main study (CT-COV-21), and are unblinded due to urgent condition other than safety events (i.e. on request from participants with high risk of acquiring and transmitting infection) after Day 119, are eligible.

2. Female participant must:

1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal;

2. Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the last injection of study intervention. Acceptable forms include:

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

3. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.

4. Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent

Exclusion Criteria

1. Pregnant or breast feeding or have plan to become pregnant in 30 days after last administration of study intervention.

2. 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

3. Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.

4. Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.

5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.

6. Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of study intervention.

7. Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of study intervention.

8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention

9. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses or received any other COVID-19 vaccine.

10. Participant with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901.

11. Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medigen Vaccine Biologics Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Szu-Min Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Tzou-Yien Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gang Memorial Hospital, LinKou

Locations

Changhua Christian Hospital

Changhua, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Municipal Wan Fang Hospital

Taipei, , Taiwan

Taipei Veteran General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang-Guang Memorial Hospital Lin-Kou

Taoyuan District, , Taiwan

Tao-Yuan General Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CT-COV-21e

Identifier Type: -

Identifier Source: org_study_id