A Heterologous Prime-boost Study to Evaluate Immunogenicity and Safety of mRNA-1273 With MVC-COV1901 in Adults

NCT05079633 | Completed Phase 4

• 1 other identifier: 202108058MINB
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin, the immunogenicity against the VoCs, the antigen specific cellular immune response, as well as the potential efficacy of study intervention in preventing COVID-19.

Conditions

Covid19 Vaccine

Keywords

Covid19 vaccine

Outcome Measures

Primary Outcomes (4)

• Primary Immunogenicity-GMT

  To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Geometric mean titer (GMT)

  Day 1 to Day 15

• Primary Immunogenicity-SCR

  To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Seroconversion rate (SCR)

  Day 1 to Day 15

• Primary Immunogenicity-GMR

  To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -GMT ratio

  Day 1 to Day 15

• Primary Safety

  To evaluate the safety and tolerability of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273) from Day 1 to Day 29 The number and percentage of participants with the occurrence of: * Solicited local adverse events (AEs) * Solicited systemic AEs * Unsolicited AEs

  Day 1 to Day 29

Secondary Outcomes (4)

• Secondary Immunogenicity-GMT

  Day 29 to Day 181

• Secondary Immunogenicity-SCR

  Day 29 to Day 181

• Secondary Immunogenicity-GMR

  Day 29 to Day 181

• Secondary Safety

  Day 1 to Day 181

Other Outcomes (6)

• Exploratory (antigen-specific immunoglobulin)-GMT

  Day 29 to Day 181

• Exploratory (antigen-specific immunoglobulin)-SCR

  Day 29 to Day 181

• Exploratory (antigen-specific immunoglobulin)-GMR

  Day 29 to Day 181

Study Arms (2)

Moderna COVID-19 vaccine (mRNA 1273)

ACTIVE COMPARATOR

110 participants will be randomly assigned to Moderna COVID 19

Biological: Homologous boost schedule

Medigen COVID-19 vaccine (MVC COV1901)

EXPERIMENTAL

110 participants will be randomly assigned to Medigen COVID 19 vaccine

Biological: Heterologous boost schedule

Interventions

Homologous boost schedule BIOLOGICAL

1st dose mRNA 1273 , 2nd dose mRNA 1273

Moderna COVID-19 vaccine (mRNA 1273)

Heterologous boost schedule BIOLOGICAL

1st dose mRNA 1273 , 2nd dose MVC COV1901

Medigen COVID-19 vaccine (MVC COV1901)

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant aged ≥20 to \<70 years at randomization.
• Has received one dose of the mRNA-1273 8 to 12 weeks before randomization.
• Female participant 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 last administration 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 or the participant's legal representative 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 within 30 days after the administration of study intervention.
• Currently receiving or received any investigational intervention within 30 days prior to the study intervention.
• Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the study intervention.
• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the study intervention.
• 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 study intervention.
• 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 study intervention.
• Major surgery or any radiation therapy within 12 weeks prior to the study intervention.
• Has received any investigational or licensed COVID-19 vaccine other than mRNA-1273, or ≥ two doses of mRNA-1273.
• 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 IM injection or phlebotomy.
• Known SARS-CoV-2 infection in the recent 3 months prior to the study intervention.
• A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
• Participant who, in the investigator's judgement, is not in a 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 a participant 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.
• A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mRNA-1273 or MVC-COV1901.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Huang ST, Huang YS, Liu WD, Pan SC, Sun HY, Lien CE, Chen C, Hsieh SM. Immunogenicity and safety of heterologous mRNA-1273/MVC-COV1901 vaccination versus homologous mRNA1273 vaccination: A randomized, double-blind controlled study. J Formos Med Assoc. 2023 Nov;122(11):1165-1173. doi: 10.1016/j.jfma.2023.05.030. Epub 2023 Jun 14.

  PMID: 37321955 DERIVED

Study Officials

• Szu-Min Hsieh, MD.Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 15, 2021
• Study Start: September 30, 2021
• Primary Completion: October 8, 2021
• Study Completion: January 10, 2023
• Last Updated: March 22, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)