A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents

NCT04951388 | Completed Phase 2 DMC

• 1 other identifier: CT-COV-22
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants aged ≥ 12 to \< 18 years.

Conditions

Covid19 Vaccine

Keywords

Covid19 Vaccine

Outcome Measures

Primary Outcomes (4)

• Incidence of Adverse Events(AEs) [Safety and Tolerability]

  To evaluate the incidence of Adverse Events(AEs) of MVC-COV1901 from Visit 2 (Day 1) to Visit 6 (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 the second vaccination

• Immunogenicity of MVC-COV1901-1

  To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Geometric mean titers (GMT)

  Day 1 to 28 days after the second vaccination

• Immunogenicity of MVC-COV1901-2

  To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Seroconversion rate (SCR)

  Day 1 to 28 days after the second vaccination

• Immunogenicity of MVC-COV1901-3

  To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -GMT ratio

  Day 1 to 28 days after the second vaccination

Secondary Outcomes (4)

• Incidence of Adverse Events(AEs) [Safety and Tolerability]

  Day 1 to 180 days after the second vaccination

• Immunogenicity of MVC-COV1901-1

  Day 1 to 180 days after the second vaccination

• Immunogenicity of MVC-COV1901-2

  Day 1 to 180 days after the second vaccination

• Immunogenicity of MVC-COV1901-3

  Day 1 to 180 days after the second vaccination

Study Arms (2)

MVC-COV1901(S protein with adjuvant)

EXPERIMENTAL

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

Biological: MVC-COV1901(S protein with adjuvant)

MVC-COV1901(Saline)

PLACEBO COMPARATOR

Saline/0.5 mL

Biological: MVC-COV1901(Saline)

Interventions

MVC-COV1901(S protein with adjuvant) BIOLOGICAL

Approximately 330 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region

MVC-COV1901(S protein with adjuvant)

MVC-COV1901(Saline) BIOLOGICAL

Approximately 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

MVC-COV1901(Saline)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female participant ≥ 12 to \< 18 years of age at randomization.
• Body mass index (BMI) at or above the third percentile according to World Health Organization (WHO) BMI-for-age at the Screening Visit.
• 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, 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
• Has 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 traveling throughout the study period.
• Participant and 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.
• Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
• Participant previously received a coronavirus vaccine.
• 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
• Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
• Personal or family (linear or collateral relatives by blood within two generations) history of Guillain-Barré syndrome.
• 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.
• Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g. alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant.
• Participant with previous known SARS-CoV-1 or 2 infection.
• 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.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (5)

Mackay Memorial Hospital Hsinchu

Hsinchu, Taiwan

Location

Chang-Guang Memorial Hospital Lin-Kou

Taipei, Taiwan

Location

MacKay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital-HsinChu

Taipei, Taiwan

Location

National Taiwan University Hosptial

Taipei, Taiwan

Location

Related Publications (1)

• Liu LT, Chiu CH, Chiu NC, Tan BF, Lin CY, Cheng HY, Lin MY, Lien CE, Chen C, Huang LM. Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial. NPJ Vaccines. 2022 Dec 16;7(1):165. doi: 10.1038/s41541-022-00589-4.

  PMID: 36526640 DERIVED

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

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

Study Officials

• Li-Min Huang, M.D., Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 6, 2021
• Study Start: July 22, 2021
• Primary Completion: October 25, 2021
• Study Completion: March 21, 2022
• Last Updated: April 20, 2022

Record last verified: 2021-08

Locations

TW (5)