title: Human therapeutic cocaine vaccine: safety and immunogenicity.
abstract: This randomized, double blind, placebo controlled, phase I clinical trial assessed the safety and immunogenicity of a therapeutic cocaine vaccine TA-CD in 34 former cocaine abusers: 8 at 13 microg active vaccine, 10 at 82 microg and 10 at 709 microg, with two additional subjects getting placebo in each cohort. All got intra-muscular injections at 0-2 months and were monitored for safety and antibody production for 3 months. Of the 34 subjects 27 completed the full course of three injections, of these, only 24 returned for the final scheduled visit at day 84. The vaccine was well-tolerated and had no serious drug-related adverse events, although three subjects at the highest dose experienced brief post injection twitching. Fifteen subjects on TA-CD therapeutic vaccine were followed for 1 year. Antibody levels were correlated with vaccine dose and number of injections. Anti-cocaine antibodies were detected after the second injection, peaked at 3 months and declined to baseline by 1 year. Thus, the therapeutic vaccine was well tolerated with dose related increases in antibody levels, and a high proportion of patients recruited into the study were retained.
authors.affiliation: Department of Psychiatry, School of Medicine, Yale University, 950 Campbell Avenue, West Haven, CT 06516, USA. thomas.kosten@yale.edu
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Kosten
authors.forename: Marc
authors.initials: M
authors.lastname: Rosen
authors.forename: Julian
authors.initials: J
authors.lastname: Bond
authors.forename: Michael
authors.initials: M
authors.lastname: Settles
authors.forename: John St Clair
authors.initials: JS
authors.lastname: Roberts
authors.forename: John
authors.initials: J
authors.lastname: Shields
authors.forename: Lindsay
authors.initials: L
authors.lastname: Jack
authors.forename: Barbara
authors.initials: B
authors.lastname: Fox
mesh_terms: D000293:Adolescent; D000328:Adult; D000906:Antibodies / Q000097:blood; D003042:Cocaine / Q000276:immunology*; D019970:Cocaine-Related Disorders / Q000517:prevention & control*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D008297:Male; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000906:Antibodies; D014612:Vaccines; D003042:Cocaine