A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19

NCT04487210 | Completed Phase 1 DMC

• 1 other identifier: CT-COV-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.

Conditions

COVID-19

Keywords

COVID-19 vaccine

Outcome Measures

Primary Outcomes (1)

• Safety of MVC-COV1901

  Incidence of solicited adverse events (AEs) after vaccination, Incidence of unsolicited AEs and other AEs after vaccination, Incidence of laboratory abnormality after vaccination, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) after vaccination

  Day 1 to 28 days after second vaccination

Secondary Outcomes (8)

• Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)

  14 days, 28 days after each vaccination, and 180 days after second vaccination.

• Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)

  14 days, 28 days after each vaccination, and 180 days after second vaccination.

• Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)

  14 days, 28 days after each vaccination, and 180 days after second vaccination.

• Immunogenicity (antigen specific cellular immune responses)

  28 days and 180 days after second vaccination

• Safety of MVC-COV1901

  Day 1 to Day 209

Study Arms (3)

Phase 1a (Low Dose)

EXPERIMENTAL

15 subjects will be enrolled to receive Low-dose S-protein with adjuvant MVC-COV1901.

Biological: MVC-COV1901

Phase 1b (Medium Dose)

EXPERIMENTAL

15 subjects will be enrolled to receive Medium-dose S-protein with adjuvant MVC-COV1901.

Biological: MVC-COV1901

Phase 1c (High Dose)

EXPERIMENTAL

15 subjects will be enrolled to receive High-dose S-protein with adjuvant MVC-COV1901.

Biological: MVC-COV1901

Interventions

MVC-COV1901 BIOLOGICAL

MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.

Phase 1a (Low Dose); Phase 1b (Medium Dose); Phase 1c (High Dose)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy volunteer ≥20 and \<50 years of age
• Subject free of ongoing acute diseases or serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigator's opinion could interfere with the results of the trial or adversely affect the safety of the subject
• Female subject 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, must be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following last injection of study vaccines. Acceptable forms include:
• Implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS)
• 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) withspermicidal foam/gel/film/cream/suppository
• Have a negative pregnancy test
• Subject is willing and able to comply with all required study visits and follow-up required by this protocol
• Subject has no overseas travel within 14 days of screening and will not have any throughout the study period
• Subject must provide written informed consent or the Subject's legal representative must understand and consent to the procedure

You may not qualify if:

• Receiving any investigational intervention either currently or within 30 days of first dose;
• Subject (particularly who is a healthcare worker) with previous known or potential exposure to SARS CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other COVID-19 vaccine;
• Administration of any vaccine within 4 weeks of first dose;
• A BMI greater than or equal to 30 kg/m2;
• Subject 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;
• Administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose;
• Pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines;
• History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg) or any potentially communicable infectious disease as determined by the investigator or Medical Monitor;
• Positive serologic test for hepatitis C (EXCEPTION: successful treatment with confirmation of sustained virologic response);
• Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL;
• Screening laboratory tests with Grade 2 or higher abnormality (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007);
• Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
• A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.);
• Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose;
• Current or anticipated treatment with TNF-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose;

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

• Hsieh SM, Chang SC, Cheng HY, Shih SR, Lien CE. Durability and Immunogenicity of Neutralizing Antibodies Response Against Omicron Variants After Three Doses of Subunit SARS-CoV-2 Vaccine MVC-COV1901: An Extension to an Open-Label, Dose-Escalation Phase 1 Study. Infect Dis Ther. 2022 Aug;11(4):1493-1504. doi: 10.1007/s40121-022-00652-6. Epub 2022 May 17.

  PMID: 35579840 DERIVED

• Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC. Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study. EClinicalMedicine. 2021 Aug;38:100989. doi: 10.1016/j.eclinm.2021.100989. Epub 2021 Jun 26.

  PMID: 34222848 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

MVC-COV1901 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: October 7, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 6, 2021
• Last Updated: January 31, 2022

Record last verified: 2021-08

Locations

TW (1)