Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

Exclusion Criteria

• •HIV infection
• •HIV vaccines or placebos in prior HIV trial
• •Immunosuppressive medications within 168 days prior to first study vaccination
• •Blood products within 120 days prior to first study vaccination
• •Live attenuated vaccines within 30 days prior to first study vaccination
• •Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
• •Pneumococcal vaccine within 14 days prior to first study vaccination
• •Allergy treatment with antigen injections within 30 days prior to first study vaccination
• •Current anti-tuberculosis (TB) preventive therapy or treatment
• •Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
• •Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
• •Any job-related responsibility that would interfere with the study
• •Allergies to local amide-type anesthetics
• •Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• •Autoimmune disease or immunodeficiency
• •Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
• •Moderate to severe asthma. More information on this criterion can be found in the protocol.
• •Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
• •Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
• •Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry
• •Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry
• •Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol.
• •Bleeding disorder
• •Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
• •Absence of the spleen
• •Plans to become pregnant during the study
• •Pregnancy or breastfeeding
• •Exclusion Criterion for Participants in Part B:
• •Allergies to yeast-derived products