Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults

Inclusion Criteria:

• Good general health
• Normal hematological, hepatic and renal functions
• Demonstrated understanding of study
• Willing to receive HIV test results
• HIV-1 and -2 uninfected
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
• Adequate contraception. For more information on this criterion can be found in the protocol.

Exclusion Criteria:

• HIV vaccines or placebos in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
• Blood products within 120 days prior to first injection
• Immunoglobulin within 60 days prior to first injection
• Investigational agents within 30 days prior to first injections
• Live attenuated vaccine within 30 days prior to first injection
• Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
• Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
• Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
• Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
• Known autoimmune disease
• Known immunodeficiency
• Asthma other than mild, well-controlled asthma
• Diabetes mellitus type 1 or 2
• Thyroidectomy or thyroid disease in the12 months prior to study entry
• Angioedema in the 3 years prior to study entry
• Hypertension. More information on this criterion can be found in the protocol.
• Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
• Bleeding disorder
• Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
• Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
• Absence of spleen
• Individuals at high-risk of acquiring HIV infection
• Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48
• Pregnancy or breastfeeding