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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
| Faculty of Medicine, Diponegoro University, Semarang | UNKNOWN |
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The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Candidate Formula A | Experimental | 2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose) |
|
| Vaccine Candidate Formula B | Experimental | 2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose) |
|
| Vaccine Candidate Formula C | Experimental | 2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose) |
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| Vaccine Candidate Formula D | Experimental | 2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose) |
|
| Active Control | Active Comparator | 2 doses of active control administered with 28 days interval (0.5 mL per dose) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 protein subunit recombinant vaccine | Biological | candidate vaccine manufactured by PT. Bio Farma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the vaccine within 7 days after each dose | percentage of subjects with solicited and unsolicited Adverse Events (AE) | 7 days after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| safety of the vaccine within 28 days after each dose | percentage of subjects with solicited and unsolicited AE | 28 days after each dose |
| Serious Adverse Event (SAE) of the vaccine | percentage of subjects with at least 1 SAE |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immunity evaluation | Positive rate of specific T-cell response | 14 days after the last dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Rini Sekartini, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Yetty Movieta Nency, MD | Faculty of Medicine, Diponegoro University, Semarang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Diponegoro University, Semarang | Semarang | Central Java | Indonesia | |||
| Fakultas Kedokteran Universitas Indonesia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking
| SARS-CoV-2 inactivated vaccine | Biological | active control manufactured by Sinovac Life Sciences Co.Ltd |
|
| 6 months after the last dose |
| Comparison of safety between vaccine and active control | percentage of subjects with AE and SAE between vaccine and active control group | 28 days after each dose and 6 months after the last dose |
| Deviation of laboratory evaluation | Any deviation from routine laboratory evaluation that probably related to the dosing | 7 days after the first dose and 14 days after the last dose |
| Inflammatory factor evaluation | The change of interleukin-6 (IL-6) in serum | 7 days after the first dose and 14 days after the last dose |
| Immunogenicity profile after the last dose | GMT of IgG antibody and neutralization antibody | 14 days and 28 days after the last dose |
| Immunogenicity profile after the last dose | seroconversion rate of IgG antibody and neutralization antibody | 14 days and 28 days after the last dose |
| Comparison of immunogenicity profile | GMT of IgG antibody and neutralization antibody | 14 days and 28 days after the last dose |
| Comparison of immunogenicity profile | seroconversion rate of IgG antibody and neutralization antibody | 14 days and 28 days after the last dose |
| Jakarta |
| Greater Jakarta |
| Indonesia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |