HIV-1 Vaccine Test in Uninfected Adult Volunteers

• INCLUSION CRITERIA:

A participant must meet all of the following criteria:

• 18 to 40 years old.
• Available for follow-up for the duration of the study (12 months).
• Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to sign the informed consent form.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to have blood samples used for future research.
• Willing to discuss HIV infection risks and amenable to risk reduction counseling.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.

Laboratory Criteria within 28 days prior to enrollment:

• Hematocrit greater than or equal to 34 percent for women; greater than or equal to 38 percent for men.
• WBC count: Non-African Americans equals 3,300-12,000 cells/mm(3); African-Americans equals 2,500-12,000 cells/mm(3) (in the absence of clinical or pathological etiology).
• Differential either within institutional normal range or accompanied by site physician approval.
• 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).
• Platelets equals 125,000-550,000/mm(3).
• ALT (SGPT) less than or equal to 1.5 times upper limit of normal.
• Serum creatinine less than or equal to 1.3 mg/dL.
• Normal urinalysis defined as negative glucose, negative or trace protein, and negative or trace hemoglobin (blood).
• Negative FDA-approved HIV blood test.
• Negative Hepatitis B surface antigen.
• Negative anti-HCV or negative HCV PCR if the anti-HCV is positive.

Female-Specific Criteria:

• Negative beta-HCG pregnancy test for women presumed to be of reproductive potential.
• 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 conditions apply:

-Woman who is breast-feeding.

Volunteer has received any of the following substances:

• HIV vaccines in a prior clinical trial.
• Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis.
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines ( e.g., influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.

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

• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• 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 corticosteroids.
• Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• Thyroid disease including history of thyroidectomy and diagnoses that required medication within the past 12 months.
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years.
• Hypertension that is not well controlled by medication or is more than 150/100 at enrollment.
• 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.
• Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
• 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.
• 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.
• Asplenia or any condition resulting in the absence or removal of the spleen.
• 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.
• 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.