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First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity.
Vaccine. 2008 Nov 05; 26(47):5922-7.V

Abstract

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 (20IU/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 1 to day 21 after a single dose of CL184 20 or 40IU/kg. All subjects had adequate (>0.5IU/mL) RVNA levels from day 14 onwards when combined with rabies vaccine. CL184 appears promising as an alternative to RIG in PEP.

Authors+Show Affiliations

Crucell Holland BV, Leiden, The Netherlands. lex.bakker@crucell.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18804136

Citation

Bakker, A B H., et al. "First Administration to Humans of a Monoclonal Antibody Cocktail Against Rabies Virus: Safety, Tolerability, and Neutralizing Activity." Vaccine, vol. 26, no. 47, 2008, pp. 5922-7.
Bakker AB, Python C, Kissling CJ, et al. First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity. Vaccine. 2008;26(47):5922-7.
Bakker, A. B., Python, C., Kissling, C. J., Pandya, P., Marissen, W. E., Brink, M. F., Lagerwerf, F., Worst, S., van Corven, E., Kostense, S., Hartmann, K., Weverling, G. J., Uytdehaag, F., Herzog, C., Briggs, D. J., Rupprecht, C. E., Grimaldi, R., & Goudsmit, J. (2008). First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity. Vaccine, 26(47), 5922-7. https://doi.org/10.1016/j.vaccine.2008.08.050
Bakker AB, et al. First Administration to Humans of a Monoclonal Antibody Cocktail Against Rabies Virus: Safety, Tolerability, and Neutralizing Activity. Vaccine. 2008 Nov 5;26(47):5922-7. PubMed PMID: 18804136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - First administration to humans of a monoclonal antibody cocktail against rabies virus: safety, tolerability, and neutralizing activity. AU - Bakker,A B H, AU - Python,C, AU - Kissling,C J, AU - Pandya,P, AU - Marissen,W E, AU - Brink,M F, AU - Lagerwerf,F, AU - Worst,S, AU - van Corven,E, AU - Kostense,S, AU - Hartmann,K, AU - Weverling,G J, AU - Uytdehaag,F, AU - Herzog,C, AU - Briggs,D J, AU - Rupprecht,C E, AU - Grimaldi,R, AU - Goudsmit,J, Y1 - 2008/09/17/ PY - 2008/06/13/received PY - 2008/07/22/revised PY - 2008/08/31/accepted PY - 2008/9/23/pubmed PY - 2009/2/10/medline PY - 2008/9/23/entrez SP - 5922 EP - 7 JF - Vaccine JO - Vaccine VL - 26 IS - 47 N2 - 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 (20IU/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 1 to day 21 after a single dose of CL184 20 or 40IU/kg. All subjects had adequate (>0.5IU/mL) RVNA levels from day 14 onwards when combined with rabies vaccine. CL184 appears promising as an alternative to RIG in PEP. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/18804136/First_administration_to_humans_of_a_monoclonal_antibody_cocktail_against_rabies_virus:_safety_tolerability_and_neutralizing_activity_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(08)01203-6 DB - PRIME DP - Unbound Medicine ER -