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Covid19 VaccinePhase 2COVID-19NCT04695652

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

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 12 sites in 2 countries.

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 who are generally healthy or with stable pre-existing health conditions. Read more about this study

Who is it for?
Ages 20 years and olderHealthy 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
3,854 participants
Where
12 sitesin 2 countries
Study dates
30 Dec 2020to 29 Oct 2021
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
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  • 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.

Who cannot join

  • 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.
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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 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.
  • 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 (e.g. New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%), renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g. alcoholism, drug abuse), current severe infections, 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.
  • Medigen Vaccine Biologics Corp. 34
  • Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and completed the 14-day self-managements/ home quarantines/ home isolations) 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Taiwan11 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Medical University Hospital

    Taipei

  • Taipei Municipal Wan Fang Hospital

    Taipei

  • Taipei Veteran General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang-Guang Memorial Hospital Lin-Kou

    Taoyuan

  • Tao-Yuan General Hospital

    Taoyuan

Other trials in Taiwan

Vietnam1 site

  • National Institute of Hygiene and Epidemiology

    Hanoi

Other trials in Vietnam

About this study

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

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.

Read the detailed description

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center, multi-regional study; the Sponsor will be blinded until the interim analysis. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by age (≥ 20 to < 65 years and ≥ 65 years of age).All eligible participants will be randomized to receive 2 doses of either MVC-COV1901 or placebo in a predefined 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 3180 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 530 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 NCT04695652
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 Event within 28 days post the second study intervention (Safety of MVC-COV1901)

    To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1) to Visit 7 (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 second vaccination

  2. Immunogenicity of MVC-COV1901

    To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers

    Measured: Day 1 to 28 days after second vaccination

Secondary outcomes (2)

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

    To evaluate the safety 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 second vaccination

  2. lot to lot consistency

    To evaluate the lot-to-lot consistency of MVC-COV1901 in participants of the ≥ 20 to < 65 years age group, the equivalence of the neutralizing antibody Geometric Mean Titer(GMT) among 3 different lots of MVC-COV1901

    Measured: Day 1 to 28 days after 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 posted5 Jan 2021
  2. Study start30 Dec 2020
  3. Primary completion15 May 2021
  4. Study completion29 Oct 2021

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
Double blind
Who is masked
Participant, Investigator
Enrolment
3,854 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04695652
Sponsor's protocol ID
CT-COV-21
Acronym
COVID-19
Status last verified
Dec 2020
First submitted
31 Dec 2020
Last updated
31 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.

    PubMed 38503664

  • Cheng SH, Lien CE, Hsieh SM, Cheng CY, Liu WD, Lo CL, Ko WC, Chen YH, Huang CT, Chang HT, Hwang SJ, Wang NC, Liu MC, Lee YL, Tai IC, Estrada JAG, Lin TY, Lee WS. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines (Basel). 2022 Dec 21;11(1):18. doi: 10.3390/vaccines11010018.

    PubMed 36679862

  • Hsieh SM, Liu MC, Chen YH, Lee WS, Hwang SJ, Cheng SH, Ko WC, Hwang KP, Wang NC, Lee YL, Lin YL, Shih SR, Huang CG, Liao CC, Liang JJ, Chang CS, Chen C, Lien CE, Tai IC, Lin TY. Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan. Lancet Respir Med. 2021 Dec;9(12):1396-1406. doi: 10.1016/S2213-2600(21)00402-1. Epub 2021 Oct 13.

    PubMed 34655522

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 12 sites in 2 countries.

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 9 inclusion and 20 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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Taiwan, Vietnam. 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 Event within 28 days post the second study intervention (Safety of MVC-COV1901) (time frame: Day 1 to 28 days after second vaccination). The study lists 2 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 NCT04695652, which also lists 3 linked publications.

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 31 Jan 2022.

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