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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
Crimean Congo Hemorrhagic Fever Vaccine
Phase I Unit, Karolinska University Hospital
Stockholm, Sweden
RECRUITINGLocal reactions
Local reactions (pain at the injection site, redness, and swelling) for up to 7 days after each vaccine dose.
Time frame: For up to 7 days after each vaccine dose
Visual analogue scale (VAS) score
Visual analogue scale (VAS) score to rate the level of pain experienced immediately (0 minutes), and after 5, 15, 30 and 60 minutes post-EP.
Time frame: At vaccination (0 minutes), and after 5, 15, 30 and 60 minutes post-EP
Systemic events
Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) for 7 days after each vaccine dose.
Time frame: For 7 days after each vaccine dose
Unsolicited AEs
Unsolicited AEs from the first study dose to 28 days after the last vaccination.
Time frame: From the first study dose to 28 days after the last vaccination
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs)
Serious Adverse Events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) from the first study dose until the study end at 3 months after last vaccination.
Time frame: From the first study dose until the study end at 3 months after last vaccination
Change in antibody levels to the CCHF nucleocapsid protein
Change from baseline sample (a two-fold increase in endpoint titer or a 50% increase in optical density at a 1:62, 1:125, 1:250, 1:500, or 1:1000 serum dilution) in antibody levels to the CCHF nucleocapsid protein by inhouse and/or commercial assays during the study period.
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Time frame: At Baseline, day 14 and 28 post vaccine dose and at 3 months post last vaccine dose