The purpose of this study is to assess the safety and preliminary efficacy of an anti-cocaine vaccine called dAd5GNE in cocaine-dependent individuals. It uses the concept of a vaccine to treat the neurological effects of cocaine by evoking "immunity" to prevent the effects of cocaine on the brain.
This is a Phase I dose-ranging, placebo-controlled, double blind study assessing the safety and preliminary efficacy of an anti-cocaine vaccine called "dAd5GNE vaccine". The vaccine is designed to prevent cocaine from reaching the brain. The vaccine is comprised of GNE, a cocaine-like molecule that is linked to the capsid protein of a disrupted serotype 5 adenovirus. The vaccine is used to evoke "immunity" to prevent cocaine from reaching the brain. The vaccine evokes an immune system response and stimulates the creation of anti-cocaine antibodies. The antibodies bind to the cocaine molecules when a person takes cocaine and prevents the cocaine molecules from reaching the brain. This cocaine-antibody complex is not able to cross the blood brain barrier and thus eliminates the effects of cocaine on the brain, as seen in pre-clinical studies done by our group. In mice, rats and nonhuman primates, this vaccine evoked a persistent, high titer, high affinity IgG anti-cocaine antibody response. The pre-clinical studies conducted establish efficacy for high anti-cocaine antibody titers. The immunity sequesters parenterally administered cocaine in the blood, in mice, rats and nonhuman primates (Appendix I-III). For each subject, the study will take place over a period of 32 weeks from the time of the first vaccine administration, and will enroll cocaine addicts, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, Text Revisions (DSM-V-TR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
WCMC Department of Genetic Medicine
New York, New York, United States
RECRUITINGSafety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a general assessment.
Time frame: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes a blood test.
Time frame: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes urinalysis.
Time frame: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes chest x-ray.
Time frame: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes ophthalmology exam.
Time frame: 32 weeks
Safety of dAd5GNE vaccine
The primary endpoint is to establish the safety of dAd5GNE vaccine using general safety parameters, which includes EKG.
Time frame: 32 weeks
Urine cocaine metabolites
Urine will be tested for benzoylecgonine (BE). The accepted value for a positive urine cocaine is urine BE of ≥ 300 ng/mL.
Time frame: 32 weeks
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Anti-cocaine antibody levels over time
The primary endpoint is average cocaine titers (week 10 - week 22) \> 4.0 x 105 titer units.
Time frame: 32 weeks