CompletedNCT04951388Updated Apr 20, 2022

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

A Phase 2 interventional study of MVC-COV1901(S protein with adjuvant) and MVC-COV1901(Saline) in Covid19 Vaccine, sponsored by Medigen Vaccine Biologics Corp.. Completed at 5 sites in Taiwan. Open to participants aged 12 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Medigen Vaccine Biologics Corp. · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 399
Allocation: Randomized
Ages: 12 Years to 18 Years
Sex: All

Study 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.

Read the detailed description

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center study; the Sponsor will be blinded until the interim analysis. Participants aged ≥ 12 to \< 18 years will be enrolled. All eligible participants will be randomized to receive either MVC-COV1901 or placebo in a 6:1 ratio.

Conditions studied

Covid19 Vaccine

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COVID-19 7,640

Keywords

Covid19 Vaccine

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 399 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Medigen Vaccine Biologics Corp. is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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:
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);
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
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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 399 participants (actual)

Study arms

Experimental
MVC-COV1901(S protein with adjuvant)
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Biological: MVC-COV1901(S protein with adjuvant)
Placebo comparator
MVC-COV1901(Saline)
Saline/0.5 mL
Biological: MVC-COV1901(Saline)

Interventions

BiologicalMVC-COV1901(S protein with adjuvant)
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
BiologicalMVC-COV1901(Saline)
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

What researchers measure

Primary outcomes

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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Day 1 to 28 days after the second vaccination

Secondary outcomes

Incidence of Adverse Events(AEs) [Safety and Tolerability]
To evaluate the Incidence of Adverse Events(AEs) of MVC-COV1901 over the study period in terms of the number and percentage of participants with the occurrence of: \>= Grade 3 AE AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs)
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-1
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-2
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -SCR
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-3
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT ratio
Time frame: Day 1 to 180 days after the second vaccination

Study locations

5 sites

Mackay Memorial Hospital Hsinchu
Hsinchu, Taiwan
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital-HsinChu
Taipei, Taiwan
National Taiwan University Hosptial
Taipei, Taiwan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04951388
Lead sponsor: Medigen Vaccine Biologics Corp.
Responsible party: Sponsor
First posted: Jul 6, 2021
Start date: Jul 22, 2021
Primary completion: Oct 25, 2021
Completion: Mar 21, 2022
Last update: Apr 20, 2022

Study contacts

Li-Min Huang, M.D., Ph.D.

principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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