drugset / Trial / NCT06684431

Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 Against Crimean Congo Hemorrhagic Fever

NCT06684431 ↗

Phase 1 Completed 15 enrolled Karolinska Institutet
NaSingle-groupOpen-labelPrevention

Summary

This First-in-human dose-escalation vaccine phase I study aims to evaluate safety and reactogenicity of the investigational vaccine N-pVAX1, against Crimean Congo Hemorrhagic Fever, delivered by in vivo EP given as three im doses at weeks 0, 4 and 12.

Timeline

Start
2024-11-12
Primary completion
2026-03-17
Completion
2026-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject N-pVAX1 Vaccine 0.45 mg Intramuscular
Subject N-pVAX1 Vaccine 0.9 mg Intramuscular
Subject N-pVAX1 Vaccine 1.8 mg Intramuscular