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The purpose of this study is to assess the immunogenicity and safety of MVC- COV1901 vaccine compared to AZD1222 in heathy adults.
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVC-COV1901 | Experimental | S-2P protein with CpG and Aluminum Hydroxide/0.5mL |
|
| AZD1222 | Active Comparator | ChAdOx1 nCoV-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVC-COV1901 | Biological | Approximately125 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of neutralizing antibody (GMT) | To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination -GMT ratio | Day 1 to Day 43 |
| Incidence of Adverse Event within 28 days post the second study intervention | To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination The number and percentage of participants with the occurrence of:
| Day 1 to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of neutralizing antibody (GMT) | To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209 • GMT | Day 29 to Day 209 |
| Immunogenicity of neutralizing antibody(SCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of confirmed COVID-19 cases | To estimate the efficacy of MVC-COV1901, as compared to AZD1222, in the prevention of COVID-19 in terms of :
| Day 15 to Day 209 |
Inclusion Criteria:
Male or female participant aged 18 years and above at randomization.
Healthy adult or adult with pre-existing medical conditions who is in a 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.
Female participant:
i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing 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 iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history).
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.
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 |
|---|---|---|---|---|---|---|
| College of Medicine and Public Health, Ubon Ratchathani University | Warin Chamrap | Changwat Ubon Ratchathani | 34190 | Thailand | ||
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| ID | Term |
|---|---|
| C000718807 | MVC-COV1901 vaccine |
| D000090985 | ChAdOx1 nCoV-19 |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
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| AZD1222 | Biological | Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region |
|
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209
• SCR
| Day 29 to Day 209 |
| Immunogenicity of neutralizing antibody(GMT ratio) | To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209 • GMT ratio | Day 29 to Day 209 |
| Incidence of Adverse Event throughout study conduct | To evaluate the safety of MVC COV1901 compared to AZD1222 over the study period The number and percentage of participants with the occurrence of:
| Day 1 to Day 209 |
| Immunogenicity of antigen-specific immunoglobulin titers(GMT) | To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209 • GMT | Day 29 to Day 209 |
| Immunogenicity of antigen-specific immunoglobulin titers(SCR) | o evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209 • SCR | Day 29 to Day 209 |
| Immunogenicity of antigen-specific immunoglobulin titers(GMT ratio) | To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209 • GMT ratio | Day 29 to Day 209 |
| Cell Mediated Immunity | To assess cell-mediated immune response of MVC-COV1901compared to AZD1222 | Day 1 to Day 43 |
| Sunpasitthiprasong Hospital |
| Ubon Ratchathani |
| 34000 |
| Thailand |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |