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CompletedNCT05197153Updated Mar 15, 2023

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

A Phase 2 interventional study of Half dose of MVC-COV1901 and Full dose of MVC-COV1901 in COVID-19 Vaccine, sponsored by Medigen Vaccine Biologics Corp.. Completed at 4 sites in Taiwan. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Medigen Vaccine Biologics Corp. · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
804
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • COVID-19 Vaccine

Keywords

  • COVID-19 Vaccine
03

In context

Lead sponsor

Medigen Vaccine Biologics Corp. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female participants aged ≥ 18 years at randomization.
  2. 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.
  3. 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
  4. Female participants must:

    1. 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;
    2. 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:

    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

  5. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  6. Participant, and the participant's legal representative if applicable, must understand the procedures of the study and provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breast feeding or have plan to become pregnant in 30 days after the administration of study intervention.
  2. 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.
  3. Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study intervention.
  4. 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.
  5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the vaccination of study intervention.
  6. 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.
  7. 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.
  8. Major surgery or any radiation therapy within 12 weeks prior to the vaccination of study intervention.
  9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  10. 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).
  11. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  12. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, capillary leak syndrome, myocarditis, or pericarditis
  13. 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.

  14. Documented SARS-CoV1 or 2 infection prior to the study intervention.
  15. 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.
  16. 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.
  17. Any condition that is a contraindication to study intervention based on the judgement of the investigator
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
804 participants (actual)

Study arms

  • Experimental
    Half dose of MVC-COV1901

    7.5 mcg of S-2P protein with adjuvant

    Biological: Half dose of MVC-COV1901

  • Experimental
    Full dose of MVC-COV1901

    15 mcg of S-2P protein with adjuvant

    Biological: Full dose of MVC-COV1901

  • Experimental
    AZD1222

    5\*10\^10 viral particles of AZD1222

    Biological: AZD1222

  • Active comparator
    Half dose of mRNA-1273

    50 mcg mRNA encoding the pre-fusion stabilized S protein

    Biological: Half dose of mRNA-1273

Interventions

  • BiologicalHalf dose of MVC-COV1901

    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.

  • BiologicalFull dose of MVC-COV1901

    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.

  • BiologicalAZD1222

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

  • BiologicalHalf dose of mRNA-1273

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

06

What researchers measure

Primary outcomes

  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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Day1 to Day 29

Secondary outcomes

  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

    Time frame: Day 1 to Day 181

  2. Secondary Immunogenicity (Humoral)-1

    To evaluate the immunogenicity in terms of Anti-spike IgG • GMT

    Time frame: Day 1 to Day 181

  3. Secondary Immunogenicity (Humoral)-2

    To evaluate the immunogenicity in terms of Anti-spike IgG • SCR

    Time frame: Day 1 to Day 181

  4. Secondary Immunogenicity (Humoral)-3

    To evaluate the immunogenicity in terms of Anti-spike IgG • GMT ratio

    Time frame: Day 1 to Day 181

  5. Secondary Immunogenicity (Cellular)

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

    Time frame: Day 1 to Day 15

07

Study locations

4 sites
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung City, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Taipei Municipal Wan Fang Hospital
    Taipei, Taiwan
  • Taipei Veteran General Hospital
    Taipei, Taiwan
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05197153
Lead sponsor
Medigen Vaccine Biologics Corp.
Collaborators
Coalition for Epidemic Preparedness Innovations
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
Jan 22, 2022
Primary completion
Jun 1, 2022
Completion
Oct 28, 2022
Last update
Mar 15, 2023

Study contacts

Allen Lien, MD. DrPH
study chair · Medigen Vaccine Biologics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: ChAdOx1 nCoV-19

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