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.
"An alternate approach could see children vaccinated at school entry. Children aged 5–8 years exhibited adequate immune responses both after primary vaccination and after a simulated post-exposure regimen one year after the initial vaccination (3 ID doses administered on days 0, 7, and 28)  "
"In this study we investigated whether two or three ID doses of PCECV would be immunogenic in children and concluded that the current recommendation of three doses given ID is appropriate . The study population, clinical trial design, and results of the primary vaccination have been published earlier  "
[Show abstract][Hide abstract] ABSTRACT: Objectives.
To assess the immunogenicity of intradermal (ID) booster doses of Purified Chick Embryo Cell rabies vaccine (PCECV, Rabipur) administered to Thai schoolchildren one, three and five years after a primary ID pre-exposure (PrEP) vaccination series.
In this follow-up study of a randomized, open-label, phase II clinical trial, two simulated post-exposure booster doses of PCECV were administered on days 0 and 3 intradermally to 703 healthy schoolchildren, one, three or five years after primary vaccination with either two or three ID doses of 0.1 mL PCECV. Blood was drawn immediately before and 7, 14 and 365 days after the first booster dose to determine rabies virus neutralizing antibody (RVNA) concentrations.
An anamnestic response of approximately 30-fold increase in RVNA concentrations was demonstrated within 14 days after booster. All children (100%) developed adequate RVNA concentrations above 0.5 IU/mL. No vaccine related serious adverse events were seen in any of the vaccinees.
ID rabies PrEP with PCECV is safe and immunogenic in schoolchildren and the anamnestic response to a two booster dose vaccination series was found to be adequate one, three, and five years after a two- or three-dose primary PrEP vaccination series.
"Taken with the findings of long-lasting immunity following intradermal rabies vaccine in our earlier study , there is evidence to support a preexposure intradermal rabies immunization schedule based on delivering 2.0 IU spread over three doses. The interval between these three initial doses could be based on the observations of Thai studies which demonstrated effective protection with doses given on days 0, 7, and 28 described by Strady et al.  who used the intramuscular route and Kamoltham et al.  who used purified chick embryo cell vaccine given intradermally. A study by Naraporn et al.  examined the immune response to rabies booster immunization after an interval of 5 years and showed that all 36 patients who completed the study at 28 days had a good anamnestic antibody response to two intradermal booster injections of purified duck embryo cell vaccine given 3 days apart. "
[Show abstract][Hide abstract] ABSTRACT: Intradermal rabies vaccine is recommended by the World Health Organisation, but not all countries, including England, follow this recommendation. A group of 12 adults in England previously given pre-exposure intradermal rabies vaccine were considered to be non-immune to rabies because their rabies antibody titres were known to be less than 0.5 IU/mL. A cohort study examined the immunizing effect of increasing the participants'
cumulative dose of intradermal rabies to 2.0 IU. All patients subsequently demonstrated rabies antibody levels >0.5 IU·mL supporting evidence of adequate sero-conversion. No adverse effects of intradermal rabies vaccine boosting were noted. Within the limits of a small study the findings support the hypothesis that adequate levels of rabies antibody can be achieved by a schedule of intradermal injections delivered on at least three occasions with a cumulative rabies vaccine dose of 2.0 IU.
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