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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
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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 of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult - Vaccine candidate | Experimental | 50 µg dose, adult group (18-59 years) |
|
| Adult - Control | Active Comparator | SARS-CoV-2 inactivated vaccine, adult group (18-59 years) |
|
| Elderly - Vaccine candidate | Experimental | 50 µg dose, elderly group (> 60 years) |
|
| Elderly - Control | Active Comparator | SARS-CoV-2 inactivated vaccine, elderly group (> 60 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 Protein Subunit Recombinant Vaccine | Biological | intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the SARS-CoV-2 protein subunit recombinant 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 SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose | percentage of subjects with solicited and unsolicited AE | 28 days after each dose |
| Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Rini Sekartini, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Jakarta | Greater Jakarta | 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 | intramuscular injection |
|
percentage of subjects with AE and SAE between vaccine and active control group |
| 28 days after each dose |
| Deviation of laboratory evaluation | Any deviation from routine laboratory evaluation that probably related to the dosing | 28 days after the first dose |
| Deviation of laboratory evaluation | Any deviation from routine laboratory evaluation that probably related to the dosing | 7 days after whole schedule dose |
| Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody | 28 days after each dose |
| Comparison of immunogenicity between 2 and 3 doses | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody | 28 days after second and third dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |