Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe
ABSTRACT 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.
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.
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.
Rabies pre-exposure immunization with PCECV is safe and immunogenic, and its implementation could save the lives of many children in rabies-endemic areas.
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ABSTRACT: Rabies poses a threat to more than 3.3 billion people worldwide and is estimated to cause about 60,000 deaths a year. However, according to the WHO, it is still one of the most neglected diseases in developing countries. Human rabies vaccinations are critical components of pre-exposure and post-exposure prophylaxis. Rabipur, the first purified chick embryo cell-culture vaccine, was licensed in Germany in 1984, and later in more than 60 countries worldwide. The immunogenicity, efficacy and safety of Rabipur have been assessed in numerous clinical trials in pre- and post-exposure regimens, using both intramuscular and intradermal routes of administration. The trial populations have involved adults and children, including healthy volunteers and individuals bitten by laboratory-proven rabid animals, malnourished children and immunocompromised individuals. Extensive, worldwide clinical experience with Rabipur over the past 30 years has shown the vaccine to be immunogenic, effective and generally well tolerated.Expert Review of Vaccines 03/2015; 14(3):351-67. DOI:10.1586/14760584.2015.1011134 · 4.22 Impact Factor
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ABSTRACT: Improved rabies pre- and post-exposure prophylaxis (PrEP and PEP) in developing countries uses an economic multi-site intradermal vaccination. Aim: To evaluate immunogenicity of chromatographically purified Vero cell vaccine (CPRV) for intradermal PrEP and PEP. Method: The subjects received conventional PrEP with CPRV or PVRV in PrEP study or received intradermal PEP with CPRV or PVRV and rabies immunoglobulin in PEP study. Result: All subjects who received PrEP with CPRV had protective neutralizing antibody (Nab) titers (≥ 0.5 IU/ml) 14 days after completing vaccination. In PEP study, Nab titers in the CPRV groups reached ≥ 0.5 IU/ml in all subjects by day 14 through day 90 after vaccination. The geometric mean titers of Nab in the CPRV groups had significantly higher titers than the PVRV group on day 14 through day 365 (p < 0.05). No serious adverse reactions were observed. Conclusions: CPRV is safe and immunogenic when given for intradermal PrEP and PEP.Expert Review of Vaccines 10/2014; 13(12):1-9. DOI:10.1586/14760584.2014.971764 · 4.22 Impact Factor