drugset / Trial / NCT05228613
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
Phase 1
Completed
175 enrolled
PT Bio Farma
Faculty of Medicine, Diponegoro University, Semarang · collabFakultas Kedokteran Universitas Indonesia · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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
Timeline
- Start
- 2022-02-16
- Primary completion
- 2022-08-02
- Completion
- 2023-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CoronaVac | Vaccine | 0.5 ml | — |
| Subject | SARS-CoV-2 Protein Subunit Recombinant Vaccine | Vaccine | 0.5 ml | — |