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COVID-19 VaccinePhase 1NCT05216601

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19

A Phase 1 study testing MVC-COV1901, MVC-COV1901(Beta)-15 and MVC-COV1901(Beta)-25 in people with COVID-19 Vaccine, run by Medigen Vaccine Biologics Corp. at 2 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, tolerability, and immunogenicity of a booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccine
What is being tested?
MVC-COV1901, MVC-COV1901(Beta)-15 and MVC-COV1901(Beta)-25
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
2 sitesTaiwan
Study dates
6 May 2022to 30 Nov 2022
Phase
Phase 1
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female participants ≥ 18 years and <55 years at randomization.
  • Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as a 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.
  • Documented to have received two or three homologous doses of MVC-COV1901 vaccine, 1st and 2nd doses within 12 weeks, 2nd and 3rd doses between 12~24 weeks (Group B only), and with the latest dose > 84 days prior to randomization, and did not receive any other investigational or approved COVID-19 vaccines.
  • Female participants 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 injection of study intervention. Acceptable forms include:
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  • 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. Female with childbearing potential must have a negative pregnancy test by this protocol
  • Participant is willing and able to comply with all required study visits and follow-up required
  • Participant, and the participant's legal representative if applicable, must understand the procedures of the study and provide written informed consent.

Who cannot join

  • Pregnant or breast feeding or plan to become pregnant in 30 days after the administration of study intervention.
  • Employees at the investigator's site, of the Sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study.
  • Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study intervention.
  • Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live- attenuated vaccines within 7 days prior to vaccination of study intervention.
  • Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the vaccination 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 vaccination 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 vaccination of study intervention.
  • Major surgery or any radiation therapy within 12 weeks prior to the vaccination of study intervention
  • Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  • 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 conditions (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.
  • Documented SARS-CoV-1 or 2 infection prior to the study intervention.
  • 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 MVC-COV1901 and MVC-COV1901(Beta).
  • 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 vaccination of study intervention.
  • Any condition that is a contraindication to study intervention based on the judgement of the investigator

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Taipei Medical University Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase I, Prospective, Randomized, Open-labeled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Booster Dose With MVC-COV1901 or MVC-COV1901(Beta) SARS-CoV-2 Vaccine in Adults

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:

  • The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up).
  • The treatment duration will be 1 day. -The visit frequency will be 6 on-site visits (1 screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.
Read the detailed description

This is a Phase I, prospective, randomized, open-labeled study to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with the MVC-COV1901 or MVC1901(Beta). Approximately 120 participants aged ≥18 and <55 years, who received two or three doses of MVC- COV1901 vaccines, will be enrolled and divided into two groups. Each group will consist of approximately 60 eligible subjects, and for each group the randomization will be stratified based on site to three treatment arms (15 mcg of MVC-COV1901 or 15 mcg or 25 mcg of MVC-COV1901(Beta) in 1:1:1 ratio).

Being tested
MVC-COV1901, MVC-COV1901(Beta)-15, MVC-COV1901(Beta)-25
Keywords
COVID-19 Vaccine

What participants receive

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

  • MVC-COV1901Biological

    Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region. Group A and B

  • MVC-COV1901(Beta)-15Biological

    Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-15 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region

  • MVC-COV1901(Beta)-25Biological

    Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-25 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region

Study groups in NCT05216601
Study groupRoleWhat they receive
MVC-COV1901Active comparator15 mcg of S-2P protein with adjuvant
Receives: Biological: MVC-COV1901
MVC-COV1901(Beta)-15Experimental15 mcg of S-2P protein(Beta) with adjuvant
Receives: Biological: MVC-COV1901(Beta)-15
MVC-COV1901(Beta)-25Experimental25 mcg of S-2P protein(Beta) with adjuvant
Receives: Biological: MVC-COV1901(Beta)-25

What is being measured

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

  1. Incidence of Adverse Events from Day 1 to 29

    To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose.

    • Solicited local adverse events (AEs) (up to 7 days after injection of booster dose) • Solicited systemic AEs (up to 7 days after injection of booster dose)
    • Unsolicited AEs (up to 28 days after injection of booster dose)
    • AE of special interest (AESI)
    • Vaccine-associated enhanced disease (VAED) • Serious adverse event (SAE)

    Measured: Day 1 to Day 29

  2. Primary Immunogenicity-1

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • GMT

    Measured: Day 1 to Day 29

  3. Primary Immunogenicity-2

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • GMT ratio

    Measured: Day 1 to Day 29

Secondary outcomes (4)

  1. Incidence of Adverse Events from Day 1 to 181

    To measure the incidence of adverse event throughout the whole study period.

    • ≥ Grade 3 AE
    • AESI
    • VAED
    • SAE

    Measured: Day 1 to Day 181

  2. Secondary Immunogenicity (Humoral)-1

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT

    Measured: Day 1 to Day 181

  3. Secondary Immunogenicity (Humoral)-2

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT Ratio

    Measured: Day 1 to Day 181

  4. Secondary Immunogenicity (Cellular)

    To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot)

    Measured: Day 1 to Day 91

Timeline

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

  1. First posted31 Jan 2022
  2. Study start6 May 2022
  3. Primary completion26 Jul 2022
  4. Study completion30 Nov 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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05216601
Sponsor's protocol ID
CT-COV-25
Status last verified
Jun 2022
First submitted
27 Jan 2022
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVC-COV1901, MVC-COV1901(Beta)-15 and MVC-COV1901(Beta)-25 in people with COVID-19 Vaccine, run by Medigen Vaccine Biologics Corp. at 2 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 9 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 from Day 1 to 29 (time frame: Day 1 to Day 29). The study lists 3 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 NCT05216601.

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 15 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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