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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine injected ID with classical syringe | Placebo Comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL); Left forearm, ID with classical syringe filled with vaccine (0.1mL); Non-dominant deltoid, Intramuscular (IM) with classical syringe filled with placebo (0.5mL). |
|
| Vaccine injected ID with NanoJect device (DebioJect™) | Active Comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with vaccine (0.1mL); Left forearm, ID with classical syringe filled with placebo (0.1mL); Non-dominant deltoid, IM with classical syringe filled with placebo (0.5mL). |
|
| Vaccine injected IM with classical syringe | Placebo Comparator | Right forearm, ID with NanoJect device (DebioJect™) filled with placebo (0.1mL); Left forearm, ID with classical syringe filled with placebo (0.1mL); Non-dominant deltoid, IM with classical syringe filled with vaccine (0.5mL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoJect device (DebioJect™) | Device | The investigational device used in this study is the NanoJect™ device developed by Debiotech company. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events as a Measure of Safety and Tolerability | 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 | 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 | 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 | 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 | 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| Titers of Immunoglobulin G (IgG) anti-rabies antibodies analyzed by Rapid Fluorescent Focus Inhibition Test (RFFIT) as a measure of Immunogenicity | Change between baseline and last study visit: Day 56 (visit 5). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Pantaleo | CHUV | Principal Investigator |
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| Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus) | Device | The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus) |
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| Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) | Device | The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus) |
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| Vaccin rabique Pasteur® | Drug |
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| Placebo | Drug | Sodium Chloride (NaCl) 0,9%; B. Braun |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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