Vaccine for cocaine dependence: A randomized double-blind placebo-controlled efficacy trial
We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine met...
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| Published in | Drug and alcohol dependence Vol. 140; pp. 42 - 47 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Ireland
Elsevier Ireland Ltd
01.07.2014
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0376-8716 1879-0046 1879-0046 |
| DOI | 10.1016/j.drugalcdep.2014.04.003 |
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| Abstract | We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.
This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome.
The 300 subjects (76% male, 72% African–American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths.
The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. |
|---|---|
| AbstractList | Abstract Aims We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. Methods This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. Results The 300 subjects (76% male, 72% African–American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR = 3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. Conclusions The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. The 300 subjects (76% male, 72% African–American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. Aims: We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence. Methods: This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome. Results: The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of >=42 mg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR = 3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths. Conclusions: The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. [Copyright Elsevier Ireland Ltd.] We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.AIMSWe evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.This 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome.METHODSThis 6-site, 24 week Phase III randomized double-blind placebo-controlled trial assessed efficacy during weeks 8 to 16. We measured urine cocaine metabolites thrice weekly as the main outcome.The 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths.RESULTSThe 300 subjects (76% male, 72% African-American, mean age 46 years) had smoked cocaine on average for 13 days monthly at baseline. We hypothesized that retention might be better and positive urines lower for subjects with anti-cocaine IgG levels of ≥42 μg/mL (high IgG), which was attained by 67% of the 130 vaccine subjects receiving five vaccinations. Almost 3-times fewer high than low IgG subjects dropped out (7% vs 20%). Although for the full 16 weeks cocaine positive urine rates showed no significant difference between the three groups (placebo, high, low IgG), after week 8, more vaccinated than placebo subjects attained abstinence for at least two weeks of the trial (24% vs 18%), and the high IgG group had the most cocaine-free urines for the last 2 weeks of treatment (OR=3.02), but neither were significant. Injection site reactions of induration and tenderness differed between placebo and active vaccine, and the 29 serious adverse events did not lead to treatment related withdrawals, or deaths.The vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence.CONCLUSIONSThe vaccine was safe, but it only partially replicated the efficacy found in the previous study based on retention and attaining abstinence. |
| Author | Rotrosen, John Green, Charles Tompkins, D. Andrew Shorter, Daryl Thakkar, Vatsal Kampman, Kyle Mariani, John J. Smoak, Benjamin Kosten, Thomas R. Somoza, Eugene Stitzer, Maxine Domingo, Coreen B. Levin, Frances R. Sekerka, Rachelle Orson, Frank |
| AuthorAffiliation | 3 University of Cincinnati 2 University of Texas, Houston, TX 77030 1 Baylor College of Medicine, Houston, TX 77030 6 NYU/VA NYHHS, NY, NY 7 University of Pennsylvania, Philadelphia, PA 4 Columbia University, NY, NY 5 Johns Hopkins University, Baltimore, MD |
| AuthorAffiliation_xml | – name: 7 University of Pennsylvania, Philadelphia, PA – name: 4 Columbia University, NY, NY – name: 2 University of Texas, Houston, TX 77030 – name: 6 NYU/VA NYHHS, NY, NY – name: 1 Baylor College of Medicine, Houston, TX 77030 – name: 5 Johns Hopkins University, Baltimore, MD – name: 3 University of Cincinnati |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24793366$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1007/s11920-007-0049-z 10.1093/jat/26.7.382 10.1016/j.biopsych.2005.04.032 10.1001/archgenpsychiatry.2009.128 10.1038/nm1096-1129 10.1124/jpet.106.111781 10.1021/jm030351z 10.1016/S0264-410X(01)00425-X 10.1016/S0376-8716(97)00121-X 10.1124/jpet.104.068122 10.1016/j.cbi.2010.02.036 10.1016/0264-410X(92)90030-N 10.1016/0264-410X(94)90176-7 |
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| References | American Psychiatric Association (bib0005) 1994 Gao, Orson, Kinsey, Kosten, Brimijoin (bib0030) 2010; 187 Fox (bib0015) 1997; 48 Orson, Kinsey, Singh, Wu, Gardner, Kosten (bib0080) 2007; 9 Holmgren, Czerkinsky, Lycke, Svennerholm (bib0040) 1994; 50 Jenkins, Keenan, Henningfield, Cone (bib0045) 2002; 26 Carroll, Zlebnik, Anke, Kosten, Orson, Shen, Kinsey, Parks, Gao, Brimijoin (bib0010) 2014 Norman, Tabet, Norman, Buesing, Pesce, Ball (bib0075) 2007; 320 Kosten, Rosen, Bond, Settles, Roberts, Shields, Jack, Fox (bib0060) 2002; 20 Gao, Brimijoin (bib0025) 2004; 310 Svennerholm, Gothefors, Sack, Bardhan, Holmgren (bib0105) 1984; 62 Haney, Gunderson, Jiang, Collins, Foltin (bib0035) 2010; 67 Paula, Tabet, Farr, Norman, Ball (bib0085) 2004; 47 Fox, Kantak, Edwards (bib0020) 1996; 2 Jertborn, Svennerholm, Holmgren (bib0050) 1992; 10 Jertborn, Svennerholm, Holmgren (bib0055) 1994; 12 Martell, Orson, Poling, Mitchell, Rossen, Gardner, Kosten (bib0070) 2009; 66 SAMHSA (bib0100) 2010 SAMHSA (bib0090) 2012 SAMHSA (bib0095) 2013 Martell, Mitchell, Poling, Gonsai, Kosten (bib0065) 2005; 58 Holmgren (10.1016/j.drugalcdep.2014.04.003_bib0040) 1994; 50 Gao (10.1016/j.drugalcdep.2014.04.003_bib0025) 2004; 310 Jenkins (10.1016/j.drugalcdep.2014.04.003_bib0045) 2002; 26 SAMHSA (10.1016/j.drugalcdep.2014.04.003_bib0090) 2012 Fox (10.1016/j.drugalcdep.2014.04.003_bib0015) 1997; 48 Jertborn (10.1016/j.drugalcdep.2014.04.003_bib0055) 1994; 12 Fox (10.1016/j.drugalcdep.2014.04.003_bib0020) 1996; 2 Haney (10.1016/j.drugalcdep.2014.04.003_bib0035) 2010; 67 Jertborn (10.1016/j.drugalcdep.2014.04.003_bib0050) 1992; 10 Orson (10.1016/j.drugalcdep.2014.04.003_bib0080) 2007; 9 Martell (10.1016/j.drugalcdep.2014.04.003_bib0070) 2009; 66 SAMHSA (10.1016/j.drugalcdep.2014.04.003_bib0095) 2013 Svennerholm (10.1016/j.drugalcdep.2014.04.003_bib0105) 1984; 62 Paula (10.1016/j.drugalcdep.2014.04.003_bib0085) 2004; 47 SAMHSA (10.1016/j.drugalcdep.2014.04.003_bib0100) 2010 Kosten (10.1016/j.drugalcdep.2014.04.003_bib0060) 2002; 20 Gao (10.1016/j.drugalcdep.2014.04.003_bib0030) 2010; 187 American Psychiatric Association (10.1016/j.drugalcdep.2014.04.003_bib0005) 1994 Norman (10.1016/j.drugalcdep.2014.04.003_bib0075) 2007; 320 Martell (10.1016/j.drugalcdep.2014.04.003_bib0065) 2005; 58 Carroll (10.1016/j.drugalcdep.2014.04.003_bib0010) 2014 |
| References_xml | – volume: 26 start-page: 382 year: 2002 end-page: 392 ident: bib0045 article-title: Correlation between pharmacological effects and plasma cocaine concentrations after smoked administration publication-title: J. Anal. Toxicol. – volume: 67 start-page: 59 year: 2010 end-page: 65 ident: bib0035 article-title: Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans – volume: 62 start-page: 909 year: 1984 end-page: 918 ident: bib0105 article-title: Local and systemic antibody responses and immunological memory after immunization with cholera B subunit by different routes publication-title: Bull. WHO – volume: 10 start-page: 130 year: 1992 end-page: 132 ident: bib0050 article-title: Safety and immunogenicity of an oral recombinant cholera B subunit-whole cell vaccine in Swedish volunteers publication-title: Vaccine – volume: 320 start-page: 145 year: 2007 end-page: 153 ident: bib0075 article-title: A chimeric human/murine anti-cocaine monoclonal antibody inhibits the distribution of cocaine to the brain in mice publication-title: J. Pharmacol. Exp. Ther. – volume: 58 start-page: 158 year: 2005 end-page: 164 ident: bib0065 article-title: Vaccine pharmacotherapy for the treatment of cocaine dependence publication-title: Biol. Psychiatry – volume: 187 start-page: 421 year: 2010 end-page: 424 ident: bib0030 article-title: The concept of pharmacologic cocaine interception as a treatment for drug abuse publication-title: Chem. Biol. Interact. – volume: 20 start-page: 1196 year: 2002 end-page: 1204 ident: bib0060 article-title: Human therapeutic cocaine vaccine: safety and immunogenicity publication-title: Vaccine – year: 1994 ident: bib0005 article-title: DSM-IV. Diagnostic and Statistical Manual of Mental Disorders – year: 2014 ident: bib0010 article-title: Combined cocaine hydrolase gene transfer and anti-cocaine vaccine synergistically block cocaine-induced locomotion publication-title: PLoS One – volume: 2 start-page: 1129 year: 1996 end-page: 1132 ident: bib0020 article-title: Efficacy of a therapeutic cocaine vaccine in rodent models publication-title: Nat. Med. – year: 2012 ident: bib0090 article-title: Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings – volume: 9 start-page: 381 year: 2007 end-page: 387 ident: bib0080 article-title: The future of vaccines in the management of addictive disorders publication-title: Curr. Psychiatry Rep. – volume: 47 start-page: 133 year: 2004 end-page: 142 ident: bib0085 article-title: Three-dimensional quantitative structure-activity relationship modeling of cocaine binding by a novel human monoclonal antibody publication-title: J. Med. Chem. – volume: 12 start-page: 1078 year: 1994 end-page: 1082 ident: bib0055 article-title: Immunological memory after immunization with oral cholera B subunit-whole-cell vaccine in Swedish volunteers publication-title: Vaccine – volume: 66 start-page: 1116 year: 2009 end-page: 1123 ident: bib0070 article-title: Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial publication-title: Arch. Gen. Psychiatry – year: 2010 ident: bib0100 article-title: Treatment Improvement Protocol 33: Treatment for Stimulant Use Disorders – volume: 48 start-page: 153 year: 1997 end-page: 158 ident: bib0015 article-title: Development of a therapeutic vaccine for the treatment of cocaine addiction publication-title: Drug Alcohol Depend. – volume: 310 start-page: 1046 year: 2004 end-page: 1052 ident: bib0025 article-title: An engineered cocaine hydrolase blunts and reverses cardiovascular responses to cocaine in rats publication-title: J. Pharmacol. Exp. Ther. – year: 2013 ident: bib0095 article-title: Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits – volume: 50 start-page: 42 year: 1994 end-page: 54 ident: bib0040 article-title: Strategies for the induction of immune responses at mucosal surfaces making use of cholera toxin B subunit as immunogen, carrier, and adjuvant publication-title: Am. J. Trop. Med. Hyg. – volume: 9 start-page: 381 year: 2007 ident: 10.1016/j.drugalcdep.2014.04.003_bib0080 article-title: The future of vaccines in the management of addictive disorders publication-title: Curr. Psychiatry Rep. doi: 10.1007/s11920-007-0049-z – volume: 26 start-page: 382 year: 2002 ident: 10.1016/j.drugalcdep.2014.04.003_bib0045 article-title: Correlation between pharmacological effects and plasma cocaine concentrations after smoked administration publication-title: J. Anal. Toxicol. doi: 10.1093/jat/26.7.382 – volume: 58 start-page: 158 year: 2005 ident: 10.1016/j.drugalcdep.2014.04.003_bib0065 article-title: Vaccine pharmacotherapy for the treatment of cocaine dependence publication-title: Biol. Psychiatry doi: 10.1016/j.biopsych.2005.04.032 – year: 1994 ident: 10.1016/j.drugalcdep.2014.04.003_bib0005 – volume: 66 start-page: 1116 year: 2009 ident: 10.1016/j.drugalcdep.2014.04.003_bib0070 article-title: Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial publication-title: Arch. Gen. Psychiatry doi: 10.1001/archgenpsychiatry.2009.128 – year: 2010 ident: 10.1016/j.drugalcdep.2014.04.003_bib0100 – volume: 2 start-page: 1129 year: 1996 ident: 10.1016/j.drugalcdep.2014.04.003_bib0020 article-title: Efficacy of a therapeutic cocaine vaccine in rodent models publication-title: Nat. Med. doi: 10.1038/nm1096-1129 – volume: 50 start-page: 42 year: 1994 ident: 10.1016/j.drugalcdep.2014.04.003_bib0040 article-title: Strategies for the induction of immune responses at mucosal surfaces making use of cholera toxin B subunit as immunogen, carrier, and adjuvant publication-title: Am. J. Trop. Med. Hyg. – volume: 320 start-page: 145 year: 2007 ident: 10.1016/j.drugalcdep.2014.04.003_bib0075 article-title: A chimeric human/murine anti-cocaine monoclonal antibody inhibits the distribution of cocaine to the brain in mice publication-title: J. Pharmacol. Exp. Ther. doi: 10.1124/jpet.106.111781 – year: 2012 ident: 10.1016/j.drugalcdep.2014.04.003_bib0090 – volume: 67 start-page: 59 year: 2010 ident: 10.1016/j.drugalcdep.2014.04.003_bib0035 article-title: Cocaine-specific antibodies blunt the subjective effects of smoked cocaine in humans – volume: 47 start-page: 133 year: 2004 ident: 10.1016/j.drugalcdep.2014.04.003_bib0085 article-title: Three-dimensional quantitative structure-activity relationship modeling of cocaine binding by a novel human monoclonal antibody publication-title: J. Med. Chem. doi: 10.1021/jm030351z – year: 2013 ident: 10.1016/j.drugalcdep.2014.04.003_bib0095 – volume: 20 start-page: 1196 year: 2002 ident: 10.1016/j.drugalcdep.2014.04.003_bib0060 article-title: Human therapeutic cocaine vaccine: safety and immunogenicity publication-title: Vaccine doi: 10.1016/S0264-410X(01)00425-X – volume: 48 start-page: 153 year: 1997 ident: 10.1016/j.drugalcdep.2014.04.003_bib0015 article-title: Development of a therapeutic vaccine for the treatment of cocaine addiction publication-title: Drug Alcohol Depend. doi: 10.1016/S0376-8716(97)00121-X – volume: 310 start-page: 1046 year: 2004 ident: 10.1016/j.drugalcdep.2014.04.003_bib0025 article-title: An engineered cocaine hydrolase blunts and reverses cardiovascular responses to cocaine in rats publication-title: J. Pharmacol. Exp. Ther. doi: 10.1124/jpet.104.068122 – volume: 187 start-page: 421 year: 2010 ident: 10.1016/j.drugalcdep.2014.04.003_bib0030 article-title: The concept of pharmacologic cocaine interception as a treatment for drug abuse publication-title: Chem. Biol. Interact. doi: 10.1016/j.cbi.2010.02.036 – volume: 10 start-page: 130 year: 1992 ident: 10.1016/j.drugalcdep.2014.04.003_bib0050 article-title: Safety and immunogenicity of an oral recombinant cholera B subunit-whole cell vaccine in Swedish volunteers publication-title: Vaccine doi: 10.1016/0264-410X(92)90030-N – volume: 12 start-page: 1078 year: 1994 ident: 10.1016/j.drugalcdep.2014.04.003_bib0055 article-title: Immunological memory after immunization with oral cholera B subunit-whole-cell vaccine in Swedish volunteers publication-title: Vaccine doi: 10.1016/0264-410X(94)90176-7 – volume: 62 start-page: 909 year: 1984 ident: 10.1016/j.drugalcdep.2014.04.003_bib0105 article-title: Local and systemic antibody responses and immunological memory after immunization with cholera B subunit by different routes publication-title: Bull. WHO – year: 2014 ident: 10.1016/j.drugalcdep.2014.04.003_bib0010 article-title: Combined cocaine hydrolase gene transfer and anti-cocaine vaccine synergistically block cocaine-induced locomotion publication-title: PLoS One |
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| Snippet | We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.
This... Abstract Aims We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine... We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.AIMSWe... Aims: We evaluated the immunogenicity, efficacy, and safety of succinylnorcocaine conjugated to cholera toxin B protein as a vaccine for cocaine dependence.... |
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| SubjectTerms | Abstinence Adolescent Adult Antibodies - analysis Clinical trial Cocaine Cocaine - immunology Cocaine-Related Disorders - immunology Cocaine-Related Disorders - prevention & control Double-Blind Method Drug dependency Efficacy Ethnicity Female Humans Immunotherapy Immunotherapy - methods Male Middle Aged Psychiatry Safety Treatment Outcome Urine Vaccination - methods Vaccine Vaccines Vaccines - adverse effects Vaccines - therapeutic use Young Adult |
| Title | Vaccine for cocaine dependence: A randomized double-blind placebo-controlled efficacy trial |
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