A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19

NCT05097053 | Unknown Phase 4

• 1 other identifier: TYGH110044
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants in order to demonstrate the immunogenicity and safety of heterologous third-boost with MVC-COV1901, in terms of the neutralizing antibody GMTs at 28 days after the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin as well as the potential efficacy of study intervention in preventing COVID-19. This study is aimed to recruit participants at single study site in Northern Taiwan.

Conditions

COVID-19 Vaccine

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Primary Immunogenicity

  To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in 3 months, compared to 6 months, in terms of neutralizing antibody Geometric Mean Titers (GMT)

  Day1 to 28 days after vaccination

• Primary Safety

  To evaluate the safety and tolerability of heterologous third-boost (MVC-COV1901) from Day 1 to 28 days after the study intervention The number and percentage of participants with the occurrence of: * Solicited local adverse events (AEs) * Solicited systemic AEs * Unsolicited AEs

  Day1 to 28 days after vaccination

Secondary Outcomes (2)

• Secondary Immunogenicity

  Day 1 and Day 169

• Secondary Safety

  Day 1 to Day169

Other Outcomes (1)

• Exploratory Efficacy

  Day 1 to Day 169

Study Arms (2)

MVC-COV1901 vaccine (3-month Interval)

EXPERIMENTAL

There will be approximately 100 participants (Group A) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 1

Biological: MVC-COV1901(3 Months)

MVC-COV1901 vaccine (6-month Interval)

EXPERIMENTAL

There will be approximately 100 participants (Group B) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 85.

Biological: MVC-COV1901(6 Months)

Interventions

MVC-COV1901(3 Months) BIOLOGICAL

MVC-COV1901 vaccine after a 3-month Interval

MVC-COV1901 vaccine (3-month Interval)

MVC-COV1901(6 Months) BIOLOGICAL

MVC-COV1901 vaccine after a 6-month Interval

MVC-COV1901 vaccine (6-month Interval)

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participant aged 20 to 64 years at randomization.
• Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 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 last administration of study intervention.
• Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
• Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of 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 first dose of 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 first dose of study intervention.
• Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
• Has received any other investigational or licensed COVID-19 vaccine.
• 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 first dose of 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 MVC-COV1901.

Sponsors & Collaborators

• Taoyuan General Hospital: lead
• Medigen Vaccine Biologics Corp.: collaborator

Study Sites (1)

Taoyuan General Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Interventions

MVC-COV1901 vaccine

Study Officials

• Chieh-Yu Cheng, MD.PhD.

  Taoyuan General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-Yu Cheng, MD.PhD.

CONTACT

+886-3-3699721; s841060@gm.ym.edu.tw

Shu-Hsing Cheng, MD.PhD.

CONTACT

+886-3-3699721; shcheng@mail.tygh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 27, 2021
• Study Start: October 7, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)