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DOI 10.1016/j.jpeds.2007.02.044

Медицинская библиотека · The Journal of pediatrics · 2007

Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe.

Kamoltham Thavatchai, Thinyounyong Wirawan, Phongchamnaphai Phana, Phraisuwan Phran, Khawplod Pakamatz, Banzhoff Angelika, Malerczyk Claudius

Клиническое исследование II фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод пока не подготовлен

Аннотация

OBJECTIVE

To demonstrate the safety and immunogenicity of intradermal rabies pre-exposure prophylaxis with purified chick embryo cell vaccine (PCECV) in schoolchildren age 5 to 8 years in Thailand.

STUDY

DESIGN

In a randomized, open-label, phase II clinical trial, 2 or 3 intradermal doses of 0.1 mL PCECV (Rabipur) were administered to 703 schoolchildren on days 0 and 28 or on days 0, 7, and 28. In 206 children, 2 simulated post-exposure booster doses were given 1 year after the primary vaccination series. Rabies virus- neutralizing antibody (RVNA) titers were determined by the rapid fluorescent focus inhibition test.

RESULTS

In school-age children in Thailand, a pre-exposure immunization regimen of 3 intradermal doses of PCECV produced adequate immune responses. After primary vaccination, all subjects developed RVNA titers > or =0.5 IU/mL and demonstrated a rapid increase in RVNA titer after 2 simulated post-exposure booster immunizations 1 year after the primary vaccination series. No serious adverse drug reactions occurred.

CONCLUSIONS

Rabies pre-exposure immunization with PCECV is safe and immunogenic, and its implementation could save the lives of many children in rabies-endemic areas.

Для цитирования: Kamoltham Thavatchai, Thinyounyong Wirawan, Phongchamnaphai Phana, Phraisuwan Phran, Khawplod Pakamatz, Banzhoff Angelika, Malerczyk Claudius. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe.. The Journal of pediatrics. 2007. DOI: 10.1016/j.jpeds.2007.02.044.

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