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

NCT05048849 | Completed Phase 2 DMC

• 1 other identifier: CT-COV-21e
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 11

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

Conditions

Covid19 Vaccine

Keywords

Covid19 vaccine

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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

  Day 1 to 28 days after second vaccination

Secondary Outcomes (3)

• Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)

  Day 1 to 180 days after second vaccination

• Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)

  Day 1 to 180 days after second vaccination

• Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)

  Day 1 to 28 days after second vaccination

Other Outcomes (1)

• Incidence of confirmed COVID-19 cases (Efficacy of MVC-COV1901)

  Day 1 to 180 days after second vaccination

Study Arms (1)

MVC-COV1901(S protein with adjuvant)

EXPERIMENTAL

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

Biological: MVC-COV1901(S protein with adjuvant)

Interventions

MVC-COV1901(S protein with adjuvant) 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

MVC-COV1901(S protein with adjuvant)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Female participant must:
• 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;
• 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
• Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
• Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent

You may not qualify if:

• Pregnant or breast feeding or have plan to become pregnant in 30 days after last administration of study intervention.
• 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
• Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
• 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.
• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
• 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.
• 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.
• Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention
• Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses or received any other COVID-19 vaccine.
• 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.
• 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.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (11)

Changhua Christian Hospital

Changhua, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang-Guang Memorial Hospital Lin-Kou

Taoyuan District, Taiwan

Location

Tao-Yuan General Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Szu-Min Hsieh, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Tzou-Yien Lin, MD

  Chang Gang Memorial Hospital, LinKou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 17, 2021
• Study Start: July 19, 2021
• Primary Completion: November 8, 2021
• Study Completion: April 12, 2022
• Last Updated: August 24, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (11)