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Covid19 VaccinePhase 2NCT04951388

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

A Phase 2 study testing MVC-COV1901(S protein with adjuvant) and MVC-COV1901(Saline) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 5 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Covid19 Vaccine
What is being tested?
MVC-COV1901(S protein with adjuvant) and MVC-COV1901(Saline)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
399 participants
Where
5 sitesTaiwan
Study dates
22 Jul 2021to 21 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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:
  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Mackay Memorial Hospital Hsinchu

    Hsinchu

  • Chang-Guang Memorial Hospital Lin-Kou

    Taipei

  • MacKay Memorial Hospital

    Taipei

  • National Taiwan University Hospital-HsinChu

    Taipei

  • National Taiwan University Hosptial

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents

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
Covid19 Vaccine
Being tested
MVC-COV1901(S protein with adjuvant), MVC-COV1901(Saline)
Keywords
Covid19 Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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(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

Study groups in NCT04951388
Study groupRoleWhat they receive
MVC-COV1901(S protein with adjuvant)ExperimentalS-2P protein with CpG and Aluminum Hydroxide/0.5mL
Receives: Biological: MVC-COV1901(S protein with adjuvant)
MVC-COV1901(Saline)Placebo comparatorSaline/0.5 mL
Receives: Biological: MVC-COV1901(Saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 1 to 28 days after the second vaccination

  2. 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)

    Measured: Day 1 to 28 days after the second vaccination

  3. 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)

    Measured: Day 1 to 28 days after the second vaccination

  4. 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

    Measured: Day 1 to 28 days after the second vaccination

Secondary outcomes (4)

  1. 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)

    Measured: Day 1 to 180 days after the second vaccination

  2. 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

    Measured: Day 1 to 180 days after the second vaccination

  3. 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

    Measured: Day 1 to 180 days after the second vaccination

  4. 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

    Measured: Day 1 to 180 days after the second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2021
  2. Study start22 Jul 2021
  3. Primary completion25 Oct 2021
  4. Study completion21 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951388
Sponsor's protocol ID
CT-COV-22
Status last verified
Aug 2021
First submitted
30 Jun 2021
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36526640

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MVC-COV1901(S protein with adjuvant) and MVC-COV1901(Saline) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 5 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events(AEs) [Safety and Tolerability] (time frame: Day 1 to 28 days after the second vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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