Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults

Inclusion Criteria:

• Good general health
• Willing to follow all the requirements of the study and available for follow-up for the duration of the study (14 to 16 months)
• Able and willing to provide informed consent
• Willing to undergo HIV testing and counseling and willing to receive HIV test results
• Willing to not engage in high-risk behavior for HIV infection during the study
• Willing to provide location and be visited at home
• Willing to be identified with picture identification for study purposes
• Willing to use acceptable forms of contraception
• Pregnant women and those with conditions which render phlebotomy volumes hazardous will be allowed to participate using a minimized phlebotomy schedule

Exclusion Criteria:

• HIV or HBV infection
• HIV vaccines in prior HIV vaccine trial
• Immunosuppressive or cytotoxic medications within the 6 months prior to study entry. Participants who have used corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for acute uncomplicated dermatitis are not excluded.
• Blood products within 120 days prior to study entry
• Immunoglobulin within 60 days prior to study entry
• Live attenuated vaccines within 30 days prior to first study vaccine administration
• Medically indicated subunit or killed vaccines or allergy treatment with antigen injections within 14 days prior to first study vaccine administration
• Investigational research agents within 30 days prior to first study vaccine administration
• Current tuberculosis prophylaxis or therapy
• Participated in high-risk behavior for HIV infection within 6 months prior to study entry. More information on this criterion can be found in the protocol.
• Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency
• Unstable asthma or asthma requiring emergent or urgent care, hospitalization, intubation, or oral or intravenous corticosteroids during the 2 years prior to study entry
• Diabetes mellitus type 1 or 2. Patients with gestational diabetes are not excluded.
• Thyroid disease, including removal of thyroid or disease requiring medication within 3 years prior to study entry
• Serious angioedema within 3 years prior to study entry or disease requiring medication within 2 years prior to study entry
• Uncontrolled hypertension
• Bleeding disorder
• Active syphilis
• Active cancer OR treated cancer that may recur during the duration of the study
• Seizure disorder. Participants who have had fever-related seizures prior to age 2 are not excluded.
• Absence of spleen OR partial or complete lack of splenic function
• Psychiatric condition that may interfere with the study, including past or present psychoses, bipolar disorder, or suicidal attempts
• Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
• Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
• Pregnancy, breastfeeding, or plan to become pregnant
• Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
• Incapacitating illness precluding clinic visits
• Unable to provide informed consent
• Prisoners will not be enrolled while incarcerated and if enrolled prior to incarceration, will not be followed while in confinement. Re-consent will not be required upon release from prison.