Immunogenicity and safety of two-visit, intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine in children living in rabies and Japanese encephalitis endemic country.

BACKGROUND: Reducing the number of doses required for pre-exposure prophylaxis (PrEP) would make it more feasible and cost-effective to implement in children at the highest risk of rabies exposure in Asia. We studied immune response of 2-site intradermal (ID) injection of rabies vaccine on days 0 and 28 for rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) for children living in endemic area. RESEARCH DESIGN AND METHODS: Seronegative children (n = 49) aged 12-16 months were randomized 2:1 into two groups: Group A subjects were vaccinated with 0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV), each at two sites on day (D) 0 and D28; Group B subjects were vaccinated with conventional 0.5-mL intramuscular PVRV on D0, D7 and D28. Both groups received one dose of JE-CV subcutaneously on D0 and D365. Rabies virus neutralizing antibody (RVNA) titers were measured on D0, D42 and D365 after vaccination; Japanese Encephalitis (JE) neutralizing antibody titers were determined on D0, D42, D365 and D379. RESULTS: All children had RVNA ≥ 0.5 IU/mL on D42 (geometric mean titers [GMTs] of RVNA 14.35 IU/mL [Group A] and 14.83 IU/mL [Group B], p > 0.05]). On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL (p > 0.05), respectively. All children had seroprotection following booster dose of JE-CV. There were no vaccine-related SAEs observed. CONCLUSION: The 2-site ID PrEP with PVRV on days 0 and 28 co-administrated with JE-CV are safe and immunogenic.

Immunogenicity and safety of WHO-approved TRC-ID regimen with a chromatographically purified Vero cell rabies vaccine with or without rabies immunoglobulin in children.

INTRODUCTION: Children are at risk of rabies exposure in many Asian countries. The safety and immunogenicity profile of the WHO-approved two-site intradermal Thai Red Cross regimen (modified TRC-ID regimen; 2-2-2-0-2) with a new chromatographically purified Vero-cell rabies vaccine (CPRV) is lacking. Area covered: We studied the safety and immunogenicity of the TRC-ID regimen with a new CPRV in non-immunized Thai children with possible or proven rabies exposure. Thirty-nine seronegative patients (age range 2-14 years) with rabies exposure (WHO categories II or III) received two 0.1-mL intradermal doses of CPRV at both deltoid regions on days 0, 3, 7, and 28. Twenty-five patients (64.1%) received rabies immunoglobulin due to having rabies exposure, according to WHO category III. All serum samples were tested for rabies neutralizing antibody (Nab) by the rapid fluorescent focus inhibition test (RFFIT) before vaccination, and on days 14 and 90 after vaccination. All patients had an adequate immune response (Nab titers ≥ 0.5 IU/mL) on days 14 and 90. No patients died of rabies infection. No serious adverse reactions were observed. Expert commentary: CPRV is economic, safe, and immunogenic if given as the modified TRC-ID regimen in children.