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

NCT05197153 | Completed Phase 2 DMC

• 1 other identifier: CT-COV-24
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19 Vaccine

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (5)

• 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)

  Day1 to 28 days after vaccination

• Primary Immunogenicity-1

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

  Day1 to Day 29

• Primary Immunogenicity-2

  To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • Seroconversion rate (SCR)

  Day1 to Day 29

• Primary Immunogenicity-3

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

  Day1 to Day 29

• Primary Immunogenicity-4

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

  Day1 to Day 29

Secondary Outcomes (5)

• Incidence of Adverse Events from Day 1 to 181

  Day 1 to Day 181

• Secondary Immunogenicity (Humoral)-1

  Day 1 to Day 181

• Secondary Immunogenicity (Humoral)-2

  Day 1 to Day 181

• Secondary Immunogenicity (Humoral)-3

  Day 1 to Day 181

• Secondary Immunogenicity (Cellular)

  Day 1 to Day 15

Study Arms (4)

Half dose of MVC-COV1901

EXPERIMENTAL

7.5 mcg of S-2P protein with adjuvant

Biological: Half dose of MVC-COV1901

Full dose of MVC-COV1901

EXPERIMENTAL

15 mcg of S-2P protein with adjuvant

Biological: Full dose of MVC-COV1901

AZD1222

EXPERIMENTAL

5\*10\^10 viral particles of AZD1222

Biological: AZD1222

Half dose of mRNA-1273

ACTIVE COMPARATOR

50 mcg mRNA encoding the pre-fusion stabilized S protein

Biological: Half dose of mRNA-1273

Interventions

Half dose of MVC-COV1901 BIOLOGICAL

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.

Half dose of MVC-COV1901

Full dose of MVC-COV1901 BIOLOGICAL

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.

Full dose of MVC-COV1901

AZD1222 BIOLOGICAL

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

AZD1222

Half dose of mRNA-1273 BIOLOGICAL

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

Half dose of mRNA-1273

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (4)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 37080829 DERIVED

MeSH Terms

Interventions

ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Allen Lien, MD. DrPH

  Medigen Vaccine Biologics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 19, 2022
• Study Start: January 22, 2022
• Primary Completion: June 1, 2022
• Study Completion: October 28, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)