drugset / Trial / NCT05918939
UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)
Phase 0
Unknown
350 enrolled
Dr. Soetomo General Hospital
Bioxis Pharmaceuticalls · collabIndonesia-MoH · collabUniversitas Airlangga · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is an observer blind randomized controlled trial study to evaluate the humoral immunogenicity profile - neutralizing antibody - after 28 days following vaccination with Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine as heterologue booster compared with CoronaVac administered intramuscularly in healthy adults age 18 year and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this will be the first booster study in human.
Timeline
- Start
- 2022-09-05
- Primary completion
- 2023-08-05
- Completion
- 2023-09-05
Publications
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CoronaVac | Vaccine | 3 ug | Intramuscular |
| Subject | Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) | Vaccine | 5 ug | Intramuscular |