| Eligibility |
Inclusion criteria:
- 18 to 40 years old
- Available for follow-up for the duration of the study (13 months)
- Satisfactory completion of an Assessment of Understanding prior to enrollment defined
as 90% correct with three opportunities to take test. Errors will be reviewed with
volunteer after each test.
- Able and willing to sign the informed consent form
- Willing to receive HIV counseling and testing in accordance with Ugandan Ministry of
Health Guidelines
- Willing to discuss HIV infection risks and not currently at high-risk of HIV as
defined by responses to a standard questionnaire found in the protocol, agree not to
engage in high-risk behavior for HIV during the study as defined by protocol, and
amenable to risk-reduction counseling
- Willing to permit a home visit after one of two screening visits
- In good general health without clinically significant medical history
- Physical examination and laboratory results without clinically significant findings
within 45 days prior to first injection
- Can understand and read English or Luganda
Within 45 days prior to enrollment, must meet following criteria:
- Hemoglobin greater than 11.0 g/dL for women and 12.5 g/dL for men
- White blood cell (WBC) count: 3,300 to 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. More information on this criterion can be found in the protocol.
- Total lymphocyte count greater than 800 cells/mm^3 (in the absence of clinical or
pathological etiology)
- Platelets = 125,000 to 550,000 cells/mm^3
- Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) less than
1.25 times the upper limit of normal (ULN)
- Serum creatinine less than ULN
- Normal urinalysis defined as dipstick with negative glucose, negative or trace
protein, and negative or trace hemoglobin (blood)
- Negative Food and Drug Administration (FDA)-approved HIV blood test
- Negative serum hepatitis B surface antigen test
- Negative serum hepatitis C antibody test
- Negative urine or serum-human chorionic gonadotropin (HCG) pregnancy test for all
women. A female participant must meet one of the following criteria from 21 days prior
to vaccination until 3 months following the last vaccination:
1. No reproductive potential because of a hysterectomy, bilateral oophorectomy, or
tubal ligation. Documentation from qualified medical doctor must be obtained for
confirmation of procedure, OR
2. Participant agrees to consistently practice contraception at least 21 days prior
to vaccination and throughout the duration of the study by one of the following
methods:
1. condoms, male or female, with or without a spermicide
2. diaphragm or cervical cap with spermicide
3. intrauterine device
4. contraceptive pills, Norplant or Depo-Provera
5. male partner has previously undergone a vasectomy for which there is
documentation
6. abstinence from sexual activity
- Men should not take part in this study if they plan to father a child between the
first vaccination and 3 months after the last vaccination. Men should consistently use
a condom, provide documentation of vasectomy from qualified medical doctor, practice
abstinence of sexual activity, OR his female partner should use one of the following
methods:
1. female condoms, with or without spermicide
2. diaphragm or cervical cap with spermicide
3. intrauterine device
4. contraceptive pills, Norplant or Depo-Provera
Exclusion Criteria
- Woman who is breast-feeding
- Has received HIV vaccines in a prior clinical trial
- Has received immunosuppressive or cytotoxic medications within the past 6 months with
the exception of corticosteroid nasal spray for allergic rhinitis or topical
corticosteroids for an acute uncomplicated dermatitis
- Has received blood products within 120 days prior to HIV screening
- Has received immunoglobulin within 60 days prior to HIV screening
- Has received live attenuated vaccines within 30 days prior to initial study vaccine
administration
- Has received investigational research agents within 30 days prior to initial study
vaccine administration
- Has received medically indicated subunit or killed vaccines, e.g. influenza,
pneumococcal, or allergy treatment with antigen injections, within 14 days of study
vaccine administration
- Is receiving current anti-tuberculosis (TB) prophylaxis or therapy
- History of a serious adverse reactions to vaccines such as anaphylaxis, hives,
respiratory difficulty, angioedema, or abdominal pain
- History of autoimmune disease or immunodeficiency
- History of asthma that is unstable or required emergent care, urgent care,
hospitalization, or intubation during the past 2 years or that requires the use of
oral or intravenous corticosteroids
- History of diabetes mellitus (type I or II), with the exception of gestational
diabetes
- History of thyroid disease including history of thyroidectomy and diagnoses that
required medication within the past 12 months
- History of serious angioedema episodes within the previous 3 years or requiring
medication in the previous 2 years
- History of hypertension controlled by medication or is more than 140/90 at enrollment
- History of 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
- History of active syphilis documented by exam or serology unless positive serology is
due to remote (greater than 6 months) treated infection or positive rapid plasma
reagin (RPR)/venereal disease research laboratory (VDRL) is not associated with
positive treponemal specific serology
- History of 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
- History of seizure disorder other than febrile seizures under the age of 2, seizures
secondary to alcohol withdrawal more than 3 years ago, or a singular seizure not
requiring prolonged treatment more than 3 years ago
- History of asplenia or any condition resulting in the absence or removal of the spleen
- History of psychiatric condition that precludes compliance with the protocol, past or
present psychoses, past or present bipolar disorder or suicidal ideation
- History of any medical, psychiatric, or social condition or occupational or other
responsibility that, in the judgment of the investigator, would interfere with or
serve as a contraindication to protocol adherence or a volunteer's ability to give
informed consent
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