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| Name | Class |
|---|---|
| Indonesia University | OTHER |
| Faculty of Medicine, Diponegoro University, Semarang | UNKNOWN |
| Andalas University | OTHER |
| Faculty of Medicine, Universitas Hassanudin, Makassar |
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This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.
One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Candidate Formula 1 | Experimental | 2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose) |
|
| Vaccine Candidate Formula 2 | Experimental | 2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose) |
|
| Control | Placebo Comparator | 2 doses of placebo administered with 28 days interval (0.5 mL per dose) |
|
| 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 |
|---|---|---|
| Immunogenicity of the candidate vaccine | seroconversion rate of antibody (IgG and neutralization antibody) | 14 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the candidate vaccine | percentage of subjects with solicited and unsolicited Adverse Events (AE) | 28 days after each dose |
| Serious Adverse Event (SAE) of the vaccine | percentage of subjects with at least 1 SAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Soedjatmiko SpA(K), MSi, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Diponegoro University, Semarang | Semarang | Central Java | Indonesia | |||
| Faculty of Medicine Universitas Hassanudin |
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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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| UNKNOWN |
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Vaccine candidate and placebo are masking, lot number is masking
| placebo | Biological | the placebo is NaCl injection manufactured by PT. Bio Farma |
|
| 6 months after the last dose |
| Persistence antibody of vaccine candidate | GMT of antibody (IgG and neutralization antibody) | 14 days, 28 days, 3 months, 6 months after the last dose |
| Persistence antibody of vaccine candidate | seropositive rate of antibody (IgG and neutralization antibody) | 14 days, 28 days, 3 months, 6 months after the last dose |
| Makassar |
| South Sulawesi |
| Indonesia |
| Faculty of Medicine, Universitas Andalas, Padang | Padang | West Sumatera | Indonesia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |