Human therapeutic cocaine vaccine:
safety and immunogenicity
by
Kosten TR, Rosen M, Bond J, Settles M,
Roberts JS, Shields J, Jack L, Fox B.
Department of Psychiatry, School of Medicine,
Yale University, 950 Campbell Avenue,
06516, West Haven, CT, USA
Vaccine 2002 Jan 15;20(7-8):1196-1204
ABSTRACTThis 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&mgr;g active vaccine, 10 at 82&mgr;g and 10 at 709&mgr;g, 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.Children
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Kappa receptors, dopamine D3 and cocaine01 02 03 04 05 06 07 08 09 10 11 12
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