Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year
- Conditions
- Healthy Volunteers (Rabies Immunization)
- Interventions
- Biological: HDCVBiological: PVRV
- Registration Number
- NCT03700242
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate.
The secondary objectives of the study are:
* To describe the immunogenicity of the PrEP regimen in each group
* To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination
* To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group
* To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group
- Detailed Description
Study duration per participant is approximately 403 to 436 days
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 570
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 HDCV 1 IM dose of human diploid cell vaccine (HDCV) on D0 and D7 (short HDCV IM PrEP regimen), followed by 1 IM dose of HDCV on Year (Y)1 and Y1 + 3 days Group 2 HDCV 1 IM dose of HDCV on D0, D7, and D21 (reference), followed by 1 IM dose of HDCV on Y1 and Y1 + 3 days Group 5 PVRV 2 ID doses of PVRV on D0 and D7 (short PVRV ID PrEP regimen), followed by 1 ID dose of PVRV on Y1 and Y1 + 3 days Group 3 HDCV 2 intradermal (ID) doses of HDCV on D0 and D7 (short HDCV ID PrEP regimen), followed by 1 ID dose of HDCV on Y1 and Y1 + 3 days Group 4 PVRV 1 IM dose of purified Vero cell rabies vaccine (PVRV) on D0 and D7 (short PVRV IM PrEP regimen), followed by 1 IM dose of PVRV on Y1 and Y1 + 3 days
- Primary Outcome Measures
Name Time Method Seroconversion of participant 14 days after the last PrEP vaccination Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
- Secondary Outcome Measures
Name Time Method Participant RVNA titer ratios 14 days after last PrEP vaccination Titer 14 days after the last PrEP vaccination / titer at D0
Persistence of seropositivity 6 months and 1 year after the last PrEP vaccination RVNA titer ≥ the LLOQ
Seropositivity of participant after simulated PEP vaccination 7 and 14 days after the first simulated PEP vaccination RVNA titer ≥ the LLOQ
Persistence of RVNA titer 6 months and 1 year after the last PrEP vaccination Seroconversion of participant after simulated PEP vaccination - 7 and 14 days after the first simulated PEPvaccination RVNA titer ≥ 0.5 IU/mL
Participant RVNA titer ratios (persistence assessment) 6 months and 1 year after the last PrEP vaccination RVNA titer ratios are assessed 6 months / 14 days after the last PrEP vaccination, and 1 year / 14 days after the last PrEP vaccination
Solicited injection site and systemic reactions after simulated PEP vaccination 7 days after simulated PEP vaccination Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia. Solicited systemic reactions are collected between the first and second PEP injection and within 7 days after the second PEP injection.
Participant RVNA titer Day 0 and 14 days after the last PrEP vaccination Seropositivity of participant Day 0 and 14 days after the last PrEP vaccination RVNA titer ≥ the lower limit of quantitation (LLOQ)
Participant RVNA titer after simulated PEP vaccination 1 year after the last PrEP vaccination Ratio of titers measured 7 and 14 days after the first simulated PEP vaccination / 1 year after the last PrEP vaccination
Seroconversion of participant Day 0 and 14 days after the last PrEP vaccination RVNA titer ≥ 0.5 IU/mL
Persistence of seroconversion 6 months and 1 year after the last PrEP vaccination RVNA titer ≥ 0.5 IU/mL
Solicited injection site and systemic reactions after PrEP vaccination 7 days after PrEP vaccination Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia.
Trial Locations
- Locations (2)
Investigational Site Number 001
🇵🇭Muntinlupa, Philippines
Investigational Site Number 002
🇵🇭Cebu City, Philippines