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Title
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Comparative immunogenicity and safety trial of 2 different schedules of single-visit intradermal rabies postexposure vaccination
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Author
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Abstract
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| Background Effective and safe single-visit rabies vaccination for pre- and postexposure prophylaxis (PrEP and PEP) could substantially simplify rabies prevention and therefore increase compliance. Methods In a comparative trial, 303 healthy adults received a primary vaccination that consisted of 2 intradermal (ID) doses of 0.1 mL of the purified chicken embryo cell vaccine (PCEV) during a single visit. One year later, participants were randomly assigned to receive either 4 or 2 ID PEP booster doses of 0.1 mL PCEV during a single visit. The primary endpoint for immunogenicity was the percentage of participants with an adequate antibody level (>0.5 IU/mL) 7 days after the booster doses. The safety endpoint was the proportion of participants who developed adverse events (AEs) following primary and/or booster vaccination. Results All participants, except 1 (99.3%) in each study group, had a rabies antibody titer >0.5 IU/mL on day 7 following the booster schedules. Participants exposed to the 4-dose PEP schedule had a geometric mean titer of 20 IU/mL vs 14 IU/mL for the 2-dose PEP schedule (P = .0228). Local reactions at the injection site following PrEP and PEP were mild and transient and only seen in 14.9% and 49.6%-53% of the participants, respectively. No serious AEs were reported. Conclusions In healthy adults, a 2-dose (2 x 0.1 mL) single-visit ID PEP schedule was as immunologically adequate and safe as a 4-dose (4 x 0.1 mL) single-visit PEP schedule 7 to 28 months following a 2-dose (2 x 0.1 mL) single-visit ID PREP. |
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Language
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English
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Source (journal)
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Clinical infectious diseases. - Chicago, Ill.
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Publication
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Chicago, Ill.
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2019
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ISSN
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1058-4838
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DOI
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10.1093/CID/CIY983
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Volume/pages
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69
:5
(2019)
, p. 797-804
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ISI
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000482420100010
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Pubmed ID
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30566636
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Full text (Publisher's DOI)
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Full text (open access)
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