drugset / Trial / NCT04333459

Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS

NCT04333459 ↗

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

EvaluationDrugModalityDoseRoute
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