A randomized open-label trial of 2-dose or 3-dose pre-exposure rabies prophylaxis among Thai children
| Autor: | Noppadol Wacharachaisurapol, Nattapong Jitrungruengnij, Wachiraporn Saengseesom, Thanyawee Puthanakit, Supranee Buranapraditkun, Jiratchaya Sophonphan, Chitsanu Pancharoen, Orawan Anunsittichai, Suvaporn Anugulruengkitt, Watsamon Jantarabenjakul, Pakpoom Janewongwirot |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Rabies 030231 tropical medicine medicine.disease_cause Antibodies Viral 03 medical and health sciences 0302 clinical medicine Rabies vaccine Internal medicine Chlorocebus aethiops medicine Animals Humans 030212 general & internal medicine Child Vero Cells General Veterinary General Immunology and Microbiology biology business.industry Immunogenicity Rabies virus Public Health Environmental and Occupational Health medicine.disease Thailand Antibodies Neutralizing Vaccination Regimen Titer Infectious Diseases Rabies Vaccines Child Preschool biology.protein Molecular Medicine Female Antibody business medicine.drug |
| Zdroj: | Vaccine. 37(36) |
| ISSN: | 1873-2518 |
| Popis: | Background World Health Organization changed the recommendation for pre-exposure rabies prophylaxis from 3-dose to 2-dose regimen in 2018. Given limited data of 2-dose regimens in pediatric population, this study aimed to compare the immunogenicity between 2-dose and 3-dose pre-exposure rabies immunization. Methods This study was conducted among healthy children aged 2–12 years. They were randomized to 2-dose vaccination (2D) on days 0 and 28 or 3-dose vaccination (3D) on days 0, 7, and 28. Purified Vero cell rabies vaccine (PVRV-Verorab™) was administered intramuscularly. Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure. RVNA titers ≥0.5 IU/ml were considered adequate antibody. T cell specific response to rabies vaccine antigen was measured using the interferon-gamma enzyme linked immunospot assay. Results From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled. Median age was 5.8 years (IQR 4.4–7.3). All participants had RVNA titers ≥0.5 IU/ml after primary vaccination [GMT 2D: 18.6 (95%CI 15.9–21.8) and 3D: 16.3 (95%CI 13.2–20.1 IU/ml), p = 0.35]. At 1-year prior to receiving the booster, only 80% of the children in 2D group maintained RVNA titers ≥0.5 IU/ml compared to 100% of the children in 3D group (p = 0.01). However, all participants in both groups had RVNA ≥0.5 IU/ml at 7-day post booster vaccination [GMT 2D: 20.9 (95%CI 17.4–25.3) and 3D: 22.2 (95%CI 15.8–31.4) IU/ml (P = 0.75)]. The median number of IFN-γ secreting cells at 7-day post-booster dose was 98 and 128 SFCs per 106 PBMCs in the 2D and 3D groups, respectively (P = 0.30). Conclusions Two-dose primary rabies immunization provided adequate antibody at post primary vaccination and post booster. The results support 2-dose regimen of pre-exposure rabies immunization in the pediatric population. |
| Databáze: | OpenAIRE |
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