HIV-1 Vaccine Test in Uninfected Adult Volunteers

INCLUSION CRITERIA:

A participant must meet all of the following criteria:

1. 18 to 60 years old.
2. Available for follow-up for the duration of the study (12 months).
3. Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
4. Able and willing to sign the informed consent form.
5. Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
6. Willing to have blood samples used for future research.
7. Willing to complete questionnaire to identify HIV infection risks and amendable to risk reduction counseling.
8. In good general health without clinically significant medical history.

9. Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.

   Laboratory Criteria within 28 days prior to enrollment:

10. Hematocrit greater than or equal to 34% for women; greater than or equal to 38% for men
11. WBC count: Non-African Americans equals 3,300-12,000 cells/mm(3); African-Americans equals 2,500-12,000 cells/mm(3) (in absence of clinical or pathological etiology)
12. Differential either within institutional normal range or accompanied by site physician approval
13. Total lymphocyte count: Non-African Americans greater than or equal to 800 cells/mm(3); African Americans greater than or equal to 650 cells/mm(3) (in the absence of clinical or pathological etiology)
14. Platelets equals 125,000-550,000/mm(3)
15. ALT (SGPT) less than or equal to 1.5 X upper limit of normal
16. Serum creatinine less than or equal to 1.4 mg/dL
17. Normal urinalysis defined as negative glucose, negative or trace protein, and negative or trace hemoglobin.
18. Negative FDA-approved HIV blood test
19. Negative Hepatitis B surface antigen

20. Negative anti-HCV or negative HCV PCR if the anti-HCV is positive

    Female-Specific Criteria:

21. Negative beta-HCG pregnancy test for women presumed to be of reproductive potential.
22. A female participant must meet one of the following criteria:

No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation.,

Or

Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study,

Or

Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration of the study by one of the following methods:

condoms, male or female, with or without a spermicide

diaphragm or cervical cap with spermicide

intrauterine device

contraceptive pills, Norplant, or Depo-Provera

male partner has previously undergone a vasectomy for which there is documentation.

EXCLUSION CRITERIA:

A volunteer will be excluded if one or more of the following is true.

Women:

1. Woman who is breast-feeding.

   Volunteer has received any of the following substances:

2. HIV vaccines in a prior clinical trial
3. Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteriods for an acute uncomplicated dermatitis
4. Blood products within 120 days prior to HIV screening
5. Immunoglobulin within 60 days prior to HIV screening
6. Live attenuated vaccines within 30 days prior to initial study vaccine administration
7. Investigational research agents within 30 days prior to initial study vaccine administration
8. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration

9. Current anti-TB prophylaxis or therapy

   Volunteer has a history of any of the following clinically significant conditions:

10. Serious adverse reactions of vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
11. Autoimmune disease or immunodeficiency
12. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteriods.
13. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
14. Thyroid disease including history of thyroidectomy and diagnoses that required medication within the past 12 months.
15. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
16. Hypertension that is not well controlled by medication or is more than 150/100 at enrollment.
17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
18. Syphilis infection that is active or positive serology due to a syphilis infection treated less than six months ago.
19. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study is eligible.
20. Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring prolonged treatment more than 3 years ago.
21. Asplenia or any condition resulting in the absence or removal of the spleen.
22. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
23. Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contraindication to protocol adherence or a volunteer's ability to give informed consent.