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Covid19 VaccinePhase 2NCT04822025

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

A Phase 2 study testing MVC-COV1901 (High-Dose) and MVC-COV1901(Mid-Dose) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 4 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 in two different dose forms in participants who are generally healthy or with stable pre-existing health conditions. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19 Vaccine
What is being tested?
MVC-COV1901 (High-Dose) and MVC-COV1901(Mid-Dose)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
4 sitesTaiwan
Study dates
20 May 2021to 28 Jan 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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Male or female participant ≥ 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.
  • 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 is able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative) based on the assessment of the investigator and must provide written informed consent.

Who cannot join

  • Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) who are 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 (IV) immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
  • Participant previously received any coronavirus vaccine.
  • 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.
  • 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 known human immunodeficiency virus (HIV) infection or who is HIV antibody positive, 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).
  • Participant who, in the investigator's judgement, is not in stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include aparticipant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
  • Participant with previous known SARS-CoV-1 or 2 infection or potential exposure to SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative or completed the self-managements/ home quarantines/ home isolations)
  • 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

4 sites in 1 country.

Taiwan4 sites

  • Hualien Tzu Chi Hospital

    Hualien City

  • Shuang H Hospital

    New Taipei City

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Medical Hospital Linkou

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase II, Prospective, Randomized, Double-Blind, Dose-Comparison, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901 in Elderly Adults

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

Read the detailed description

This is a Phase II, prospective, randomized, double-blinded (investigator/site staff and participants; Sponsor open), dose-comparison, multi-center study. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by comorbidity. All eligible participants will be randomized to receive 2 doses of either High-dose or Mid-dose of MVC-COV190 in a predefined ratio.

Conditions
Covid19 Vaccine
Being tested
MVC-COV1901 (High-Dose), MVC-COV1901(Mid-Dose)
Keywords
Covid19 vaccine

What participants receive

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

  • MVC-COV1901 (High-Dose)Biological

    Approximately 300 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(Mid-Dose)Biological

    Approximately 100 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

Study groups in NCT04822025
Study groupRoleWhat they receive
High DoseExperimentalHigh-Dose S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Receives: Biological: MVC-COV1901 (High-Dose)
Mid DoseExperimentalMid-Dose S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Receives: Biological: MVC-COV1901(Mid-Dose)

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

    To evaluate the immunogenicity of High-dose MVC-COV1901, as compared to Mid-dose MVC-COV1901, in terms of neutralizing antibody titers.

    Measured: Day 1 to 28 days after the second vaccination

Secondary outcomes (2)

  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

    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 7 (90 days after the second dose of study intervention) and Visit 8 (180 days after the second dose of study intervention) in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers

    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 posted30 Mar 2021
  2. Study start20 May 2021
  3. Primary completion25 Aug 2021
  4. Study completion28 Jan 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
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04822025
Sponsor's protocol ID
CT-COV-23
Status last verified
Jun 2021
First submitted
25 Mar 2021
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Waits A, Chen JY, Cheng WH, Yeh JI, Hsieh SM, Chen C, Janssen R, Lien CE, Lin TY. Safety and immunogenicity of MVC-COV1901 vaccine in older adults: Phase 2 randomized dose-comparison trial. Int J Infect Dis. 2022 Nov;124:21-26. doi: 10.1016/j.ijid.2022.08.021. Epub 2022 Aug 29.

    PubMed 36049700

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MVC-COV1901 (High-Dose) and MVC-COV1901(Mid-Dose) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 4 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 5 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 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 NCT04822025, 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 28 Jun 2022.

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