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document
A simplified 4-site economical intradermal post-exposure rabies vaccine regimen : a randomised controlled comparison with standard methods . BACKGROUND The need for economical rabies post-exposure prophylaxis ( PEP ) is increasing in developing countries . Implementation of the two currently approved economical intradermal ( ID ) vaccine regimens is restricted due to confusion over different vaccines , regimens and dosages , lack of confidence in intradermal technique , and pharmaceutical regulations . We therefore compared a simplified 4-site economical PEP regimen with standard methods . METHODS Two hundred and fifty-four volunteers were randomly allocated to a single blind controlled trial . Each received purified vero cell rabies vaccine by one of four PEP regimens : the currently accepted 2-site ID ; the 8-site regimen using 0.05 ml per ID site ; a new 4-site ID regimen ( on day 0 , approximately 0.1 ml at 4 ID sites , using the whole 0.5 ml ampoule of vaccine ; on day 7 , 0.1 ml ID at 2 sites and at one site on days 28 and 90 ) ; or the standard 5-dose intramuscular regimen . All ID regimens required the same total amount of vaccine , 60 % less than the intramuscular method . Neutralising antibody responses were measured five times over a year in 229 people , for whom complete data were available . FINDINGS All ID regimens showed similar immunogenicity . The intramuscular regimen gave the lowest geometric mean antibody titres . Using the rapid fluorescent focus inhibition test , some sera had unexpectedly high antibody levels that were not attributable to previous vaccination . The results were confirmed using the fluorescent antibody virus neutralisation method . CONCLUSIONS This 4-site PEP regimen proved as immunogenic as current regimens , and has the advantages of requiring fewer clinic visits , being more practicable , and having a wider margin of safety , especially in inexperienced hands , than the 2-site regimen . It is more convenient than the 8-site method , and can be used economically with vaccines formulated in 1.0 or 0.5 ml ampoules . The 4-site regimen now meets all requirements of immunogenicity for PEP and can be introduced without further studies . TRIAL REGISTRATION Controlled-Trials.com ISRCTN 30087513 .
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Intervention_Pharmacological
rabies vaccine
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Intervention_Pharmacological
purified vero cell rabies vaccine
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Intervention_Pharmacological
standard 5-dose
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Outcome_Physical
immunogenicity .
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Outcome_Physical
geometric mean antibody titres .
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Outcome_Physical
high antibody levels
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Outcome_Physical
immunogenic
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Outcome_Physical
immunogenicity for PEP
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Participant_Condition
rabies vaccine regimen
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Participant_Condition
rabies
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Participant_Sample-size
Two hundred and fifty-four