drugset / Trial / NCT04333459
Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS
RandomizedParallel-groupDouble-blindDiagnostic
Summary
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
Timeline
- Start
- 2021-08-23
- Primary completion
- 2024-10-15
- Completion
- 2024-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hantaan DNA Vaccine | Vaccine | 1 mg | Intramuscular |
| Comparator | Hantaan DNA Vaccine | Vaccine | 2 mg | Intramuscular |
| Comparator | Puumala DNA Vaccine | Vaccine | 1 mg | Intramuscular |
| Comparator | Puumala DNA Vaccine | Vaccine | 2 mg | Intramuscular |