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

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 \<5 years prior to screening.
• •13. Receipt of blood within 3 months of screening.
• •14. Females who are pregnant or nursing.
• •15. Concurrent participation in any other FDA approved Investigational New Drug.
• •16. Abnormal liver function (transaminases greater than 2x the upper limit of normal values)
• •17. eGFR \<30 mL/min/1.73 m2
• •18. Severe substance use disorder based on DSM-V-TR criteria (excluding cocaine, nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment) currently not in remission according to one of the following criteria:
• •* Early Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met for at least 1 month, but less than 12 months OR
• •* Early Partial Remission: This specifier is used if only one or more (but not all) of the criteria for Dependence or Abuse has/have been met for at least 1 month, but less than 12 months. OR
• •* Sustained Full Remission: This specifier is used if none of the criteria for Dependence or Abuse have been met at any time during a period of 12 months or longer OR
• •* Sustained Partial Remission: This specifier is used if only one or more (but not all) of the criteria for Dependence or Abuse has/have been met for a period of 12 months or longer OR
• •* On Agonist Therapy: This specifier is used if the individual is on a prescribed agonist medication, and none of the criteria for Dependence or Abuse has been met for that class of medication for at least the past month (except tolerance to, or withdrawal from, the agonist). This category also applies to those being treated for Dependence using a partial agonist or an agonist/antagonist OR
• •* Substance Use Related Disorder (mild) up to two disorders: Patients that are assessed to have mild substance-use-related disorders according to the DSM-V criteria will be allowed to participate in the study as long as the number of the disorder-resulting substances does not exceed two (with the exception of the nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment).
• •19. History of any seizure disorder.
• •20. Individuals with history of Guillain-Barré Syndrome.
• •21. Diagnosis of \>2 Substance Use Related Disorders (mild) based on DSM-V- TR criteria (excluding nicotine, caffeine, alcohol, marijuana and opiates prescribed for medication assisted therapy or pain treatment
• •22. On a prescribed agonist medication, with criteria for dependence or abuse for that class ofmedication for at least the past month (except tolerance to, or withdrawal from, the agonist