Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MVC-COV1901 | Experimental | S-2P protein with CpG and Aluminum Hydroxide/0.5mL |
|
| AZD1222 | Experimental | ChAdOx1 nCoV-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVC-COV1901 | Biological | Approximately 471 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 ratio) | 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 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.
Female participants:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis Francisco Armoa Garcia, MD.Ph.D. | University of Asuncion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Fundación Tesai | Ciudad del Este | Paraguay | ||||
| Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AZD1222 | Biological | Approximately 471 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 180 days after second vaccination |
| 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) | To 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 |
| San Lorenzo |
| Paraguay |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |