NCT06684431

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The study vaccine dose is planned to be staggered, starting with the low-dose group (0.45 mg), followed by the mid-dose group (0.9 mg), and finally the high-dose group (1.8 mg). In total 15 healthy volunteers at the ages of 18-60 will be enrolled. Primary objective: • The primary objective of this study is to assess the safety and reactogenicity of the investigational vaccine N-pVAX1 delivered by in vivo EP given as three im doses at weeks 0, 4 and 12. The secondary objectives: • To investigate the humoral immune response to the investigational vaccine administered as three doses, by measuring CCHF nucleocapsid antibody levels. Exploratory objective: • To investigate in more detail the humoral response and to analyze the cellular immune response to the investigational vaccine. Trial participants will be followed-up for local and systemic adverse reactions throughout the study period. Blood samples to measure presence of antibody levels to the vaccine components and cellular immunity will be taken at Day 14 and 28 post first and second vaccine dose and at Day 14 and 3 months post last vaccine dose.

Conditions

• Crimean Congo Hemorrhagic Fever

Interventions

Type	Name	Description
BIOLOGICAL	N-pVAX1	Crimean Congo Hemorrhagic Fever Vaccine

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-03-17
• Completion: 2026-03-17
• First posted: 2024-11-12
• Last updated: 2026-03-23

Locations

1 site across 1 country: Sweden