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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
201
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular
Investigational site number 7640002
Bangkok, Thailand
Investigational site number 7640001
Bangkok, Thailand
Investigational site number 7640003
Bangkok, Thailand
Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)
Time frame: Day 14 (post-vaccination)
Percentage of participants achieving RVNA titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by RFFIT
Time frame: Day 35 (post-vaccination)
Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 14 (post-vaccination)
Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 35 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated
Time frame: Day 14 (post-vaccination
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated
Time frame: Day 35 (post-vaccination)
Number of participants reporting immediate adverse events (AEs)
Unsolicited (spontaneously reported) systematic AEs
Time frame: Within 30 minutes post-vaccination
Percentage of participants reporting solicited injection site and systemic reactions
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)
Time frame: Within 7 days post-vaccination
Number of participants reporting unsolicited injection site AEs
Unsolicited injection site AEs
Time frame: Within 28 days post-vaccination
Number of participants reporting unsolicited systemic AEs
Unsolicited systemic AEs
Time frame: Between each vaccination and up to 28 days after the last vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Time frame: Up to 6 months after last vaccination
Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (≥) 0.5 IU/mL
RVNA titers will be measured by RFFIT
Time frame: Day 90 (post-vaccination)
Number of Participants achieving RVNA titer greater than or equal to (≥) lower limit of quantification
RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL
Time frame: Day 90 (post-vaccination)
Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)
RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 - RVNA ratios Day90/Day0 will be calculated
Time frame: Day 90 (post-vaccination)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.