The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.
This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each volunteer will receive three injections at each of three vaccination visits. Total study duration per volunteer is 2 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
66
The investigational device used in this study is the NanoJect™ device developed by Debiotech company.
The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus)
The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)
Number of Adverse Events as a Measure of Safety and Tolerability
Time frame: At the end of the study, at Day 56 (visit 5).
Pain Scores at needle insertion and at product injection as measured by the Visual Analog Scale
Time frame: At each product injection: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4).
Pain following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Redness following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Pruritus following product injection as a Measure of Safety and Tolerability
Time frame: Change between baseline and 30 minutes after each injection, the evening after each injection and daily up to 3 days after each injection (product injection visits: Day 0 (visit 2), Day 7 (visit 3) and at Day 28 (visit 4)).
Titers of Immunoglobulin G (IgG) anti-rabies antibodies analyzed by Rapid Fluorescent Focus Inhibition Test (RFFIT) as a measure of Immunogenicity
Time frame: Change between baseline and last study visit: Day 56 (visit 5).
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Sodium Chloride (NaCl) 0,9%; B. Braun