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)
- Interventions
- Biological: Purified inactivated rabies vaccineBiological: Purified vero rabies vaccine - serum freeBiological: Human rabies immunoglobulins
- 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
- Arm && Interventions
Group Intervention Description Group 2: Verorab + HRIG Purified inactivated rabies vaccine Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0 Group 2: Verorab + HRIG Human rabies immunoglobulins Verorab 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0 Group 1: VRVg-2 + HRIG Purified vero rabies vaccine - serum free VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0 Group 1: VRVg-2 + HRIG Human rabies immunoglobulins VRVg-2 4 injections: 2 at Day 0, 1 at Day 7, 1 at Day 21 + HRIG at D0
- 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 unsolicited injection site AEs Within 28 days post-vaccination Unsolicited injection site AEs
Number of participants reporting immediate adverse events (AEs) Within 30 minutes post-vaccination Unsolicited (spontaneously reported) systematic AEs
Number of participants reporting unsolicited systemic AEs Between each vaccination and up to 28 days after the last vaccination Unsolicited systemic 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 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
Trial Locations
- Locations (3)
Investigational site number 7640003
🇹🇭Bangkok, Thailand
Investigational site number 7640001
🇹🇭Bangkok, Thailand
Investigational site number 7640002
🇹🇭Bangkok, Thailand