Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland
- Conditions
- Rabies (Healthy Volunteers)
- Registration Number
- NCT04594551
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
Primary Objective:
To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.
Secondary Objective:
Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.
Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.
- Detailed Description
The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification Day 35 (post-vaccination) RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) Day 35 (post-vaccination) RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated
Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL Day 14 (post-vaccination) RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL Day 35 (post-vaccination) RVNA titers will be measured by RFFIT
- Secondary Outcome Measures
Name Time Method Number of participants reporting immediate adverse events (AEs) Within 30 minutes post-vaccination Unsolicited (spontaneously reported) systematic AEs
Percentage of participants reporting solicited injection site and systemic reactions Within 7 days post-vaccination Solicited injection site reactions:
- pain, erythema, and swelling in adults (aged ≥ 18 years)
Solicited systemic reactions:
- fever, headache, malaise and myalgia in adults (aged ≥ 18 years)Number of participants reporting unsolicited injection site AEs Within 28 days post-vaccination Unsolicited injection site AEs
Number of participants reporting serious adverse events (SAEs) Up to 6 months after last vaccination SAEs, including adverse event of special interest (AESIs)
Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL Day 90 (post-vaccination) RVNA titers will be measured by RFFIT
Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification Day 90 (post-vaccination) RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination) Day 90 (post-vaccination) RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 - RVNA ratios Day90/Day0 will be calculated
Number of participants reporting unsolicited systemic AEs Between each vaccination and up to 28 days after the last vaccination Unsolicited systemic AEs
Trial Locations
- Locations (3)
Investigational site number 7640002
🇹🇭Bangkok, Thailand
Investigational site number 7640001
🇹🇭Bangkok, Thailand
Investigational site number 7640003
🇹🇭Bangkok, Thailand
Investigational site number 7640002🇹🇭Bangkok, Thailand