Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05197153
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Medigen Vaccine Biologics Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Biological: Half dose of MVC-COV1901 Biological: Full dose of MVC-COV1901 Biological: AZD1222 Biological: Half dose of mRNA-1273 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 22, 2022
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
Experimental: Half dose of MVC-COV1901
7.5 mcg of S-2P protein with adjuvant
Biological: Half 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.

Experimental: Full dose of MVC-COV1901
15 mcg of S-2P protein with adjuvant
Biological: Full 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.

Experimental: AZD1222
5*10^10 viral particles of AZD1222
Biological: AZD1222
Approximately 240 participants will receive 1 doses of AZD1222 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region.

Active Comparator: Half dose of mRNA-1273
50 mcg mRNA encoding the pre-fusion stabilized S protein
Biological: Half 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.




Primary Outcome Measures :
  1. Incidence of Adverse Events from Day 1 to 28 [ Time Frame: Day1 to 28 days after vaccination ]

    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)

  2. Primary Immunogenicity-1 [ Time Frame: Day1 to Day 29 ]

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

    • GMT


  3. Primary Immunogenicity-2 [ Time Frame: Day1 to Day 29 ]

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

    • Seroconversion rate (SCR)


  4. Primary Immunogenicity-3 [ Time Frame: Day1 to Day 29 ]

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

    • GMT ratio


  5. Primary Immunogenicity-4 [ Time Frame: Day1 to Day 29 ]

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

    • Seroresponse rate



Secondary Outcome Measures :
  1. Incidence of Adverse Events from Day 1 to 181 [ Time Frame: Day 1 to Day 181 ]

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

    • ≥ Grade 3 AE
    • AESI
    • VAED
    • SAE

  2. Secondary Immunogenicity (Humoral)-1 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT


  3. Secondary Immunogenicity (Humoral)-2 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • SCR


  4. Secondary Immunogenicity (Humoral)-3 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT ratio


  5. Secondary Immunogenicity (Cellular) [ Time Frame: Day 1 to Day 15 ]
    To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197153


Contacts
Layout table for location contacts
Contact: Heather Weng +886-2-77450830 ext 602 heatherweng@medigenvac.com
Contact: Howard Cheng +886-2-77450830 ext 601 howardcheng@medigenvac.com

Locations
Layout table for location information
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Yen-Hsu Chen, MD         
Principal Investigator: Yen-Hsu Chen         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Sung-Ching Pan, MD         
Principal Investigator: Sung-Ching Pan         
Taipei Municipal Wan Fang Hospital Recruiting
Taipei, Taiwan
Contact: Ying-Chin Lin, MD         
Principal Investigator: Ying-Chin Lin         
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan
Contact: Yi-Tsung Lin, MD. PhD.         
Principal Investigator: Yi-Tsung Lin         
Sponsors and Collaborators
Medigen Vaccine Biologics Corp.
Coalition for Epidemic Preparedness Innovations
Investigators
Layout table for investigator information
Study Chair: Allen Lien, MD. DrPH Medigen Vaccine Biologics
Layout table for additonal information
Responsible Party: Medigen Vaccine Biologics Corp.
ClinicalTrials.gov Identifier: NCT05197153    
Other Study ID Numbers: CT-COV-24
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medigen Vaccine Biologics Corp.:
COVID-19 Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases