A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study

NCT05038618 | Completed Phase 2 DMC

• 1 other identifier: CT-COV-21s
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

This sub-study is a prospective open-label, single-center study to demonstrate comparability of different manufacturing scales.

Conditions

Covid19 Vaccine

Keywords

Covid19 vaccine

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Event within 28 days post the second study intervention (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 and 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

  To evaluate the immunogenicity of MVC-COV1901among different manufacturing scales in terms of neutralizing antibody titers 28 days after the second vaccination

  Day 1 to 28 days after second vaccination

Secondary Outcomes (2)

• Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901)

  Day 1 to 180 days after second vaccination

• Immunogenicity of MVC-COV1901

  Day 1 to 180 days after second vaccination

Other Outcomes (2)

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

  Day 1 to 180 days after second vaccination

• Cell-mediated immune response of MVC-COV1901

  Day 1 to 14 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 400 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 - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participant ≥ 20 to \< 65 years, or ≥ 65 years of age at randomization.
• Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
• 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 has not travelled overseas within 14 days of screening and will not have any oversea travelling throughout the study period.
• 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.
• 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 Medical Conditions
• Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
• A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).
• A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
• Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
• Human immunodeficiency virus (HIV) antibody positive participants with CD4 count \< 350 cells/mm3 or a detectable HIV viral load within the past year (low level variations from 50-500 viral copies/mL or equivalent which do not lead to changes in antiretroviral therapy \[ART\] are permitted).
• Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e antigen (HBeAg) or abnormal liver function.
• Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic acid (RNA) viremia in recent 12 weeks.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (1)

Chang-Guang Memorial Hospital Lin-Kou

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: August 25, 2021
• First Posted: September 9, 2021
• Study Start: August 2, 2021
• Primary Completion: October 14, 2021
• Study Completion: March 11, 2022
• Last Updated: June 13, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)