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COVID-19 VaccinePhase 2NCT05197153

A Study to Evaluate the Safety and Immunogenicity of Booster With AZD1222, mRNA-1273, or MVC-COV1901 Against COVID-19

A Phase 2 study testing Half dose of MVC-COV1901, Full dose of MVC-COV1901 and AZD1222 in people with COVID-19 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, tolerability, and immunogenicity of 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 80 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 Vaccine
What is being tested?
Half dose of MVC-COV1901, Full dose of MVC-COV1901 and AZD1222
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
804 participants
Where
4 sitesTaiwan
Study dates
22 Jan 2022to 28 Oct 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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female participants aged ≥ 18 years 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.
  • Documented to have received two homologous doses of AZD1222, mRNA-1273, or MVC-COV1901 vaccine, with the latest dose between 150 and 365 days prior to randomization, with an interval between the two homologous doses of ≥ 4 weeks to ≤ 12 weeks, 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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  • 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 c.Have a negative pregnancy test
  • Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  • 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 have 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 anticipated 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 anticipated 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.
  • A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, capillary leak syndrome, myocarditis, or pericarditis
  • 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.
  • Documented SARS-CoV1 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 the AZD1222, mRNA-1273 or 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 vaccination of study intervention.
  • Any condition that is a contraindication to study intervention based on the judgement of the investigator

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • National Taiwan University Hospital

    Taipei

  • Taipei Municipal Wan Fang Hospital

    Taipei

  • Taipei Veteran General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase II, Prospective, Randomized, Observer-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Heterologous Booster Dose With AZD1222, mRNA-1273, or MVC-COV1901 COVID-19 Vaccine in Adults

The purpose of this study is to assess the safety, tolerability, and immunogenicity of 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 will include 1 booster dose only.
  • The visit frequency will be 6 on-site visits and 1 phone visit.
Read the detailed description

This is a Phase II, prospective, randomized, observer-blinded, multi-center study, to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with AZD1222, mRNA-1273, or MVC-COV1901 vaccine. Approximately 960 participants aged 18 ~ < 80 years, who received homologous two doses of vaccines 150 ~ 365 days ago, will be enrolled and divided into three groups. Each group will consist of 320 eligible subjects, and for each group the randomization will be stratified according to study site and age to four treatments (AZD1222, half dose of mRNA-1273, full dose or half dose of MVC-COV1901 in 1:1:1:1 ratio). Therefore, within a group, for either age stratum, there will be at least 30 participants for each treatment.

Being tested
Half dose of MVC-COV1901, Full dose of MVC-COV1901, AZD1222, Half dose of mRNA-1273
Keywords
COVID-19 Vaccine

What participants receive

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

  • Half dose of MVC-COV1901Biological

    Approximately 240 participants will receive 1 doses of half of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

  • Full dose of MVC-COV1901Biological

    Approximately 240 participants will receive 1 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

  • AZD1222Biological

    Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

  • Half dose of mRNA-1273Biological

    Approximately 240 participants will receive 1 doses half of mRNA-1273 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

Study groups in NCT05197153
Study groupRoleWhat they receive
Half dose of MVC-COV1901Experimental7.5 mcg of S-2P protein with adjuvant
Receives: Biological: Half dose of MVC-COV1901
Full dose of MVC-COV1901Experimental15 mcg of S-2P protein with adjuvant
Receives: Biological: Full dose of MVC-COV1901
AZD1222Experimental5*10^10 viral particles of AZD1222
Receives: Biological: AZD1222
Half dose of mRNA-1273Active comparator50 mcg mRNA encoding the pre-fusion stabilized S protein
Receives: Biological: Half dose of mRNA-1273

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 28

    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: Day1 to 28 days after vaccination

  2. Primary Immunogenicity-1

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

    • GMT

    Measured: Day1 to Day 29

  3. Primary Immunogenicity-2

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

    • Seroconversion rate (SCR)

    Measured: Day1 to Day 29

  4. Primary Immunogenicity-3

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

    • GMT ratio

    Measured: Day1 to Day 29

  5. Primary Immunogenicity-4

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

    • Seroresponse rate

    Measured: Day1 to Day 29

Secondary outcomes (5)

  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

    • SCR

    Measured: Day 1 to Day 181

  4. Secondary Immunogenicity (Humoral)-3

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT ratio

    Measured: Day 1 to Day 181

  5. Secondary Immunogenicity (Cellular)

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

    Measured: Day 1 to Day 15

Timeline

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

  1. First posted19 Jan 2022
  2. Study start22 Jan 2022
  3. Primary completion1 Jun 2022
  4. Study completion28 Oct 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
804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05197153
Sponsor's protocol ID
CT-COV-24
Status last verified
Mar 2023
First submitted
13 Dec 2021
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Estephan L, Lin YC, Lin YT, Chen YH, Pan SC, Hsieh SM, Torkehagen PF, Weng YJ, Cheng HY, Estrada JA, Waits A, Chen C, Lien CE. Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial. Vaccine. 2023 May 26;41(23):3497-3505. doi: 10.1016/j.vaccine.2023.04.029. Epub 2023 Apr 12.

    PubMed 37080829

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Half dose of MVC-COV1901, Full dose of MVC-COV1901 and AZD1222 in people with COVID-19 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 9 inclusion and 18 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 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 from Day 1 to 28 (time frame: Day1 to 28 days after vaccination). The study lists 5 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 NCT05197153, 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 15 Mar 2023.

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