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
Study duration per participant is approximately 403 to 436 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
570
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
Pharmaceutical form:Solution for injection Route of administration: Intradermal
Pharmaceutical form:Solution for injection Route of administration: Intramuscular
Pharmaceutical form:Solution for injection Route of administration: Intradermal
Investigational Site Number 002
Cebu City, Philippines
Investigational Site Number 001
City of Muntinlupa, Philippines
Seroconversion of participant
Rabies virus neutralizing antibodies (RVNA) titer ≥ 0.5 IU/mL
Time frame: 14 days after the last PrEP vaccination
Participant RVNA titer
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of RVNA titer
Time frame: 6 months and 1 year after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Time frame: 7 and 14 days after the first simulated PEP vaccination
Seroconversion of participant
RVNA titer ≥ 0.5 IU/mL
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of seroconversion
RVNA titer ≥ 0.5 IU/mL
Time frame: 6 months and 1 year after the last PrEP vaccination
Seroconversion of participant after simulated PEP vaccination -
RVNA titer ≥ 0.5 IU/mL
Time frame: 7 and 14 days after the first simulated PEPvaccination
Seropositivity of participant
RVNA titer ≥ the lower limit of quantitation (LLOQ)
Time frame: Day 0 and 14 days after the last PrEP vaccination
Persistence of seropositivity
RVNA titer ≥ the LLOQ
Time frame: 6 months and 1 year after the last PrEP vaccination
Seropositivity of participant after simulated PEP vaccination
RVNA titer ≥ the LLOQ
Time frame: 7 and 14 days after the first simulated PEP vaccination
Participant RVNA titer ratios
Titer 14 days after the last PrEP vaccination / titer at D0
Time frame: 14 days after last PrEP vaccination
Participant RVNA titer ratios (persistence assessment)
RVNA titer ratios are assessed 6 months / 14 days after the last PrEP vaccination, and 1 year / 14 days after the last PrEP vaccination
Time frame: 6 months and 1 year after the last PrEP vaccination
Participant RVNA titer after simulated PEP vaccination
Ratio of titers measured 7 and 14 days after the first simulated PEP vaccination / 1 year after the last PrEP vaccination
Time frame: 1 year after the last PrEP vaccination
Solicited injection site and systemic reactions after PrEP vaccination
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise and myalgia.
Time frame: 7 days after PrEP vaccination
Solicited injection site and systemic reactions 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.
Time frame: 7 days after simulated PEP vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.