Journal
VACCINE
Volume 26, Issue 47, Pages 5922-5927Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2008.08.050
Keywords
Vaccination; Rabies; Post-exposure prophylaxis; Monoclonal antibodies; Unmet medical need; Human rabies immunoglobulin (HRIG); Equine rabies immunoglobulin (ERIG)
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Funding
- Crucell N.V.
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Immediate passive immune prophylaxis as part of rabies post-exposure prophylaxis (PEP) often cannot be provided due to limited availability of human or equine rabies immunoglobulin (HRIG and ERIG, respectively). We report first clinical data from two phase I studies evaluating a monoclonal antibody cocktail CL184 against rabies. The Studies included healthy adult subjects in the USA and India and involved two parts. First, subjects received a single intramuscular dose of CL184 or placebo in a double blind, randomized, dose-escalation trial. Second, open-label CL184 (20 IU/kg)was co-administered with rabies vaccine. Safety was the primary objective and rabies Virus neutralizing activity (RVNA) was investigated as efficacy parameter. Pain at the CL184 injection site was reported by less than 40% of subjects; no fever or local induration, redness or swelling was observed. RVNA was detectable from day I to day 21 after a single close of CL184 20 or 40 IU/kg. All subjects had adequate (>0.5 IU/mL) RVNA levels from day 14 onwards when combined with rabies vaccine. CL184 appears promising as an alternative to RIG in PEP. (C) 2008 Elsevier Ltd. All rights reserved.
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