Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals

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.

Accrual will be random, with no bias as to gender or racial/ethnic group. Because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups among the study individuals. All subjects will be concurrently participating in behavioral therapy programs run by Dr. Beeder's clinical team. Each case will be reviewed with the Eligibility Committee, comprised of three investigators other than the PI, to determine eligibility. The Principal Investigator will not participate in this process. All subjects must fulfill all inclusion criteria and none of the exclusion criteria in order to participate in this study. Inclusion Criteria: 1. All subjects should be able to provide informed consent. 2. Must provide HIV informed consent. 3. Males and females, 21- 69 years of age. 4. Individuals that have been diagnosed with a cocaine use disorder according to DSM-V-TR criteria, with documented evidence of cocaine use within the past 60 days and have previously used an average of 1 to 10 grams of powdered and/or crack cocaine (via insufflation or smoking only) per week. Any prior 1 to 4 month period of cocaine abstinence in the past year will be excluded when calculating average cocaine use to evaluate study eligibility. 6\. Fertile males and females must agree to use adequate forms of contraception for the duration of the entire study. 7\. Body weight \> 45 kg. Exclusion Criteria: 1. Individuals not deemed in good overall health by the investigator. 2. Diagnosed history of severe psychotic disorders. 3. Abnormal EKG at screening with changes consistent with cardiac disease. 4. History of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event. 5. Individuals who are currently on beta-blockers. 6. Physical signs or laboratory values suggestive of systemic disorders. 7. History of attempted suicide, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) and/or committed homicide. 8. History of diagnosed obsessive compulsive disorder (OCD). 9. Known allergy to soy. 10. Individuals who are currently taking alprazolam (Xanax) or ziprasidone (Geodon). 11. Evidence of active infection of any types, including COVID-19, or positive for human immunodeficiency virus (HIV). 12. Historical or current use of immunomodulators or immunosuppressants \