| Eligibility |
Inclusion Criteria:
- 18 to 40 years old at the time of RV 156 enrollment
- 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 the 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 not engage in high-risk behavior for HIV infection during the study as
defined by the protocol and amenable to risk-reduction counseling and discussion of
HIV infection risks
- In good general health
- Physical examination and laboratory results without clinically significant findings
within 45 days prior to rAd5 boost injection
- Have participated in RV 156 and received all three required vaccinations
Laboratory Criteria within 45 days prior to enrollment:
- Hemoglobin greater than 11.0 g/dL for women and 12.5 g/dL for men or accompanied by
site physician approval and above the site's lower limit of normal (LLN) range
- White blood cell count (WBC) of 3,300 to 12,000 cells/mm^3 (in the absence of clinical
or pathological etiology)
- Absolute neutrophil count (ANC) within the institutional normal ranges and greater
than or equal to 1,000 cells/mm^3 or accompanied by site physician approval
- Total lymphocyte count greater than 800 cells/mm^3
- Platelets equal to 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 1.0 times the ULN range
- Normal urinalysis, defined as dipstick with negative glucose, negative or trace
protein, and negative or trace hemoglobin (blood) or determined to be not clinically
significant by site principal investigator
- Negative serology for HIV infection (e.g., enzyme linked immunosorbent assay [ELISA]
test, western blot [WB]) and HIV ribonucleic acid (RNA) below detection limits of Food
and Drug Administration (FDA)-approved viral load diagnostic assay
Pregnancy-Specific Criteria:
- Negative serum-human chorionic gonadotropin (HCG) pregnancy test for all women. A
female participant must meet one of the following criteria from the screening visit
and throughout the duration of the study:
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 (13 months).
- More information on this criterion can be found in the protocol
Exclusion Criteria:
- Pregnant, breastfeeding, or planning to become pregnant during the period of study
participation
- 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
- 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-tuberculosis (TB) prophylaxis or therapy
People with a history of any of the following clinically significant conditions will be
excluded:
- 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 2 years. Asthma that has required the use of oral or
intravenous corticosteroids during the past 2 years.
- 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 36 months
- Serious angioedema episodes within the previous 36 months or requiring medication in
the previous 2 years
- Hypertension that is not well controlled by medication or blood pressure greater than
or equal to 150/100 mm Hg (either or both values) at second screening and/or entry
visits
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions) or significant bruising or bleeding
difficulties with intramuscular (IM) injections or blood draws
- Active syphilis documented by exam or serology unless positive serology is because of
remote treated infection or positive rapid plasma regain/venereal disease research
laboratory (RPR/VDRL) test is not associated with positive Treponemal specific
serology
- Malignancy that is active, 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 febrile seizures under the age of 2
- Asplenia or splenic hypoplasia (complete or partial lack of splenic function) or any
condition resulting in the absence of a functional spleen or removal of the spleen
- Psychiatric condition that precludes compliance with the protocol, past or present
psychoses, past or present bipolar disorder, or suicidal attempts
- 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 person's ability to give informed consent
|
