The purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective: * To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives: * Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90. * Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group. * Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5. * Safety: To describe the safety profile of each group after the primary and booster vaccinations.
Participants with WHO Category II exposure will receive PEP, using "one-week, 4-site" ID vaccination regimen. Participants with WHO Category III exposure will receive PEP, using "one-week, 4-site" (4-4-4-0-0) ID vaccination regimen and pERIG Favirab® or using the updated 2-site TRC (2-2-2-0-2) ID vaccination regimen and pERIG Favirab®. All participants will receive a "single-visit, 4-site" booster vaccination five years later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally
0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
Unnamed facility
City of Muntinlupa, Philippines
Percentage of participants with seroconversion on Day 14
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Time frame: Day 14 post vaccination
Percentage of participants with seroconversion before and after primary vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Time frame: Day 0, Day 14, Day 90
Percentage of participants with seroconversion after primary vaccination (antibody persistence)
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Time frame: Year 1 to Year 5
Percentage of participants with seroconversion after booster vaccination
Seroconversion is defined as rabies virus neutralizing antibody titers ≥ 0.5 IU/mL
Time frame: Year 5 + 11 days
Geometric mean titers (GMTs) before and after primary vaccination
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Time frame: Day 0, Day 14, Day 90
GMTs after primary vaccination (antibody persistence)
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Time frame: Year 1 to Year 5
GMTs after booster vaccination
Titers of rabies virus-neutralizing antibodies were assessed by the rapid fluorescent focus inhibition test
Time frame: Year 5 + 11 days
Number of participants reporting solicited injection site reactions following primary and booster vaccination
Solicited injection site reactions are tenderness (for participants aged ≤ 23 months), pain (for participants aged ≥ 2 years), redness and swelling (for all participants)
Time frame: 7 days after each and any injection
Number of participants reporting solicited systemic reactions following primary and booster vaccination
Solicited systemic reactions are Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability for participants aged ≤ 23 months and Fever (Temperature), Headache, Malaise, and Myalgia for participants aged ≥ 2 years
Time frame: From Day 0 up to 7 days after injection 3, and 7 days after subsequent injections
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