Official Title
A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901
Brief Summary

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

Detailed Description

This is a phase I prospective, open-labeled, single-center study to evaluate the safety and
immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms
for subjects at the age of ≥20 and <50 years. The vaccination schedule for primary regimen
consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular
(IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on
Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day
209, 180 days after completion of the primary regimen.

Completed
COVID-19

Biological: MVC-COV1901

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

Eligibility Criteria

Inclusion Criteria:

1. Male or female healthy volunteer ≥20 and <50 years of age

2. 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

3. 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

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

5. Subject has no overseas travel within 14 days of screening and will not have any
throughout the study period

6. Subject must provide written informed consent or the Subject's legal representative
must understand and consent to the procedure

Exclusion Criteria:

1. Receiving any investigational intervention either currently or within 30 days of first
dose;

2. 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;

3. Administration of any vaccine within 4 weeks of first dose;

4. A BMI greater than or equal to 30 kg/m2;

5. 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;

6. Administration of any blood product or intravenous immunoglobulin administration
within 12 weeks of first dose;

7. Pregnancy or breast feeding or have plans to become pregnant in 30 days after last
injection of study vaccines;

8. 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;

9. Positive serologic test for hepatitis C (EXCEPTION: successful treatment with
confirmation of sustained virologic response);

10. Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL;

11. 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);

12. Immunosuppressive illness including hematologic malignancy, history of solid organ or
bone marrow transplantation;

13. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma,
polyarthritis, thyroiditis, etc.);

14. 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;

15. Current or anticipated treatment with TNF-α inhibitors, e.g. infliximab, adalimumab,
etanercept within 12 weeks of first dose;

16. Prior major surgery or any radiation therapy within 12 weeks of first dose;

17. Alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in
the opinion of the investigator, would interfere with adherence to study requirements
or assessment of immunologic endpoints; or any illness or condition that in the
opinion of the investigator may affect the safety of the participant or the evaluation
of any study endpoint;

18. Presence of keloid scar formation or hypertrophic scar as a clinically significant
medical condition, tattoos or wound covering the injection site area;

19. Body (oral, rectal or ear) temperature ≥ 38.0°C or acute illness within 2 days of
first dose, or acute respiratory illness within 14 days of first dose;

20. Screening laboratory test of antinuclear antibody (ANA), anti-dsDNA antibody,
anti-neutrophil cytoplasmic antibodies (ANCA, including cytoplasmic ANCA (c-ANCA),
perinuclear ANCA (p-ANCA)) with the value higher than upper normal limit;

21. Abnormal screening electrocardiography (ECG) with clinically significant findings as
reviewed by investigator.

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 50 Years
Countries
Taiwan
Locations

National Taiwan University Hospital
Taipei, Taiwan

Medigen Vaccine Biologics Corp.
NCT Number
Keywords
COVID-19 vaccine
MeSH Terms
COVID-19