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The purpose of this study is to assess the safety, tolerability, and immunogenicity of a booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:
This is a Phase I, prospective, randomized, open-labeled study to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with the MVC-COV1901 or MVC1901(Beta). Approximately 120 participants aged ≥18 and <55 years, who received two or three doses of MVC- COV1901 vaccines, will be enrolled and divided into two groups. Each group will consist of approximately 60 eligible subjects, and for each group the randomization will be stratified based on site to three treatment arms (15 mcg of MVC-COV1901 or 15 mcg or 25 mcg of MVC-COV1901(Beta) in 1:1:1 ratio).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVC-COV1901 | Active Comparator | 15 mcg of S-2P protein with adjuvant |
|
| MVC-COV1901(Beta)-15 | Experimental | 15 mcg of S-2P protein(Beta) with adjuvant |
|
| MVC-COV1901(Beta)-25 | Experimental | 25 mcg of S-2P protein(Beta) with adjuvant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVC-COV1901 | Biological | Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region. Group A and B |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events from Day 1 to 29 | To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose.
| Day 1 to Day 29 |
| Primary Immunogenicity-1 | To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT | Day 1 to Day 29 |
| Primary Immunogenicity-2 | To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29 • GMT ratio | Day 1 to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events from Day 1 to 181 | To measure the incidence of adverse event throughout the whole study period.
| Day 1 to Day 181 |
| Secondary Immunogenicity (Humoral)-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Immunogenicity-1 | To evaluate the immunogenicity in terms of neutralizing antibody titers against the Variants of Concern (VoCs) • GMT | Day 1 to Day 29 |
| Exploratory Immunogenicity-2 | To evaluate the immunogenicity in terms of neutralizing antibody titers against the Variants of Concern (VoCs) • GMT ratio |
Inclusion Criteria:
Male or female participants ≥ 18 years and <55 years at randomization.
Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as a 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.
Documented to have received two or three homologous doses of MVC-COV1901 vaccine, 1st and 2nd doses within 12 weeks, 2nd and 3rd doses between 12~24 weeks (Group B only), and with the latest dose > 84 days prior to randomization, and did not receive any other investigational or approved COVID-19 vaccines.
Female participants must:
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. Female with childbearing potential must have a negative pregnancy test by this protocol
Participant is willing and able to comply with all required study visits and follow-up required
Participant, and the participant's legal representative if applicable, must understand the procedures of the study and provide written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Lien, MD Dr.Ph | Medigen Vaccine Biologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan | ||||
| Tri-Service General Hospital |
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| ID | Term |
|---|---|
| C000718807 | MVC-COV1901 vaccine |
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| MVC-COV1901(Beta)-15 | Biological | Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-15 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region |
|
| MVC-COV1901(Beta)-25 | Biological | Approximately 40 participants who previously completed two (Group A) or three (Group B) doses of MVC-COV1901 will receive 1 doses of MVC-COV1901(Beta)-25 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region |
|
To evaluate the immunogenicity in terms of Anti-spike IgG
• GMT
| Day 1 to Day 181 |
| Secondary Immunogenicity (Humoral)-2 | To evaluate the immunogenicity in terms of Anti-spike IgG • GMT Ratio | Day 1 to Day 181 |
| Secondary Immunogenicity (Cellular) | To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot) | Day 1 to Day 91 |
| Day 1 to Day 29 |
| Taipei |
| Taiwan |