Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-uninfected Adults

Exclusion Criteria

• •1. Blood products received within 120 days before first vaccination
• •2. Investigational research agents received within 30 days before first vaccination
• •3. Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
• •4. Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing
• •5. Pregnant or breastfeeding
• •6. Active duty and reserve US military personnel Vaccines and other Injections
• •7. HIV vaccine(s) received in a prior HIV vaccine trial.
• •8. Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial, unless the vaccine subsequently received regulatory approval or emergency authorization.
• •9. Live attenuated vaccines, other than influenza vaccine, received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
• •10. Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
• •11. Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System
• •12. Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical immunosuppressives; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses \< 60 mg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment.)
• •13. Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
• •14. Immunoglobulin received within 60 days before first vaccination
• •15. Autoimmune disease, connective tissue disease, or history of vasculitis, eg, leukocytoclastic vasculitis, Henoch-Schonlein Purpura
• •16. Immunodeficiency Clinically significant medical conditions
• •17. Untreated or incompletely treated syphilis infection
• •18. Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
• •* A process that would affect the immune response,
• •* A process that would require medication that affects the immune response,
• •* Any contraindication to repeated injections or blood draws,
• •* A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
• •* A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
• •19. Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
• •20. Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
• •21. Current anti-tuberculosis (TB) prophylaxis or therapy
• •Asthma other than mild, well-controlled asthma.
• •Exclude a volunteer who:
• •* Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
• •* In the past year has either of the following:
• •* Greater than 1 exacerbation of symptoms treated with oral/ parenteral corticosteroids;
• •* Needed emergency care, urgent care, hospitalization, or intubation for asthma
• •23. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
• •24. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
• •25. Hypertension:
• •* If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic at enrollment.
• •* If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
• •26. Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• •27. Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
• •28. Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
• •29. Asplenia: any condition resulting in the absence of a functional spleen
• •30. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.