A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult

NCT ID: NCT04695652

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3854 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2021-10-29

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.

Detailed Description

This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center, multi-regional study; the Sponsor will be blinded until the interim analysis. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by age (≥ 20 to < 65 years and ≥ 65 years of age).All eligible participants will be randomized to receive 2 doses of either MVC-COV1901 or placebo in a predefined ratio.

Conditions

Covid19 Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

MVC-COV1901(S protein with adjuvant)

S-2P protein with CpG and Aluminum Hydroxide/0.5mL

Group Type: EXPERIMENTAL

MVC-COV1901(S protein with adjuvant)

Intervention Type: BIOLOGICAL

Approximately 3180 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region

MVC-COV1901(Saline)

Saline/0.5 mL

Group Type: PLACEBO_COMPARATOR

MVC-COV1901(Saline)

Intervention Type: BIOLOGICAL

Approximately 530 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

Interventions

MVC-COV1901(S protein with adjuvant)

Approximately 3180 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region

Intervention Type: BIOLOGICAL

MVC-COV1901(Saline)

Approximately 530 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female participant ≥ 20 to < 65 years, or ≥ 65 years of age 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. Female participant 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 last 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

4. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.

5. Participant has not travelled overseas within 14 days of screening and will not have any oversea travelling throughout the study period.

6. Participant or the participant's legal representative 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 last administration of study intervention.

2. Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) directly involved in the conduct of the study.

3. Currently receiving or received any investigational intervention within 30 days prior to the first dose 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 the first dose of study intervention.

5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.

6. 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.

7. 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.

8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention Medical Conditions

9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.

10. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).

11. 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).

12. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.

13. Human immunodeficiency virus (HIV) antibody positive participants with CD4 count < 350 cells/mm3 or a detectable HIV viral load within the past year (low level variations from 50-500 viral copies/mL or equivalent which do not lead to changes in antiretroviral therapy [ART] are permitted).

14. Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e antigen (HBeAg) or abnormal liver function.

15. Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic acid (RNA) viremia in recent 12 weeks.

16. 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 (e.g. New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%), renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g. alcoholism, drug abuse), current severe infections, 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.

Medigen Vaccine Biologics Corp. 34

17. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and completed the 14-day self-managements/ home quarantines/ home isolations) or received any other COVID-19 vaccine.

18. 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 MVC-COV1901.

19. 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 first dose of study intervention.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medigen Vaccine Biologics Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Szu-Min Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Tzou-Yien Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gang Memorial Hospital, LinKou

Locations

Changhua Christian Hospital

Changhua, , Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Municipal Wan Fang Hospital

Taipei, , Taiwan

Taipei Veteran General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang-Guang Memorial Hospital Lin-Kou

Taoyuan District, , Taiwan

Tao-Yuan General Hospital

Taoyuan District, , Taiwan

National Institute of Hygiene and Epidemiology

Hanoi, , Vietnam

Countries

Taiwan; Vietnam

References

Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Durocher Y. CHO cells for virus-like particle and subunit vaccine manufacturing. Vaccine. 2024 Apr 11;42(10):2530-2542. doi: 10.1016/j.vaccine.2024.03.034. Epub 2024 Mar 19.

Reference Type: DERIVED

PMID: 38503664 (View on PubMed)

Cheng SH, Lien CE, Hsieh SM, Cheng CY, Liu WD, Lo CL, Ko WC, Chen YH, Huang CT, Chang HT, Hwang SJ, Wang NC, Liu MC, Lee YL, Tai IC, Estrada JAG, Lin TY, Lee WS. A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV. Vaccines (Basel). 2022 Dec 21;11(1):18. doi: 10.3390/vaccines11010018.

Reference Type: DERIVED

PMID: 36679862 (View on PubMed)

Hsieh SM, Liu MC, Chen YH, Lee WS, Hwang SJ, Cheng SH, Ko WC, Hwang KP, Wang NC, Lee YL, Lin YL, Shih SR, Huang CG, Liao CC, Liang JJ, Chang CS, Chen C, Lien CE, Tai IC, Lin TY. Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan. Lancet Respir Med. 2021 Dec;9(12):1396-1406. doi: 10.1016/S2213-2600(21)00402-1. Epub 2021 Oct 13.

Reference Type: DERIVED

PMID: 34655522 (View on PubMed)

Other Identifiers

CT-COV-21

Identifier Type: -

Identifier Source: org_study_id