Clinical trial NCT00099463 (phase 1, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: vaccine, vrc-srsdna015-00-vp
SMILES: [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O
Eligibility criteria:

        -  INCLUSION CRITERIA:

        A participant must meet all of the following criteria:

        18 to 50 years old.

        Available for clinical follow-up through Week 32 of the study.

        Able to provide proof of identity to the satisfaction 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 complete the informed consent process.

        Willing to receive HIV test results and wiling to abide by NIH guidelines for partner
        notification of positive HIV results.

        Willing to donate blood for sample storage to be used for future research.

        In good general health without clinically significant medical history and has
        satisfactorily completed screening.

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

        Laboratory Criteria within 28 Days prior to Enrollment:

        Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL
        for men.

        WBC = 3,300-12,000 cells/mm(3).

        Absolute neutrophil count (ANC) within institutional normal range.

        Total lymphocyte count greater than or equal to 800 cells/mm(3).

        Platelets within institutional normal limits.

        ALT (SGPT) less than or equal to upper limit of normal.

        Serum creatinine less than or equal to upper limit of normal.

        Normal urinalysis defined as negative glucose, negative or trace protein, and no clinically
        significant blood in the urine.

        Negative FDA-approved HIV blood test. (Note: Results of HIV ELISA will be documented, but a
        negative HIV PCR will be sufficient for eligibility screening of subjects with positive HIV
        ELISA that is due to prior participation in an HIV vaccine study).

        Negative Hepatitis B surface antigen.

        Negative anti-HCV (hepatitis C virus antibody) and negative HCV PCR.

        Female Specific Criteria:

        Negative beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed
        to be of reproductive potential.

        A female participant must meet any 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
        through Week 32 of the study;

        Or

        Participant agrees to consistently practice contraception at least 21 days prior to
        enrollment and through Week 32 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 or patch, Norplant, Depo-Provera or other FDA-approved contraceptive
        method;

        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:

        Women:

        Woman who is breast-feeding or planning to become pregnant during the 32 weeks of study
        participation.

        Volunteer has received any of the following substances:

        Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids 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.

        Investigational research agents within 30 days prior to initial study vaccine
        administration.

        Live attenuated vaccines 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.

        History of thyroidectomy or thyroid disease that required medication within the past 12
        months.

        Serious angioedema episodes within the previous 3 years or requiring medication in the
        previous two years.

        Hypertension that is not well controlled by medication or is more than 145/95 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.

        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 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 treatment within the last 3 years.

        Asplenia, functional asplenia or any condition resulting in the absence or removal o 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, social condition, occupational reason or other responsibility
        that, in the judgment of the investigator, is a contraindication to protocol participation
        or impairs a volunteer's ability to give informed consent.

        Allergic reaction to aminoglycoside antibiotics.