Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring AIDS, HIV seronegativity, HIV preventive vaccine
Eligibility Criteria
Inclusion Criteria HIV uninfected Low risk sexual behavior Negative for Hepatitis B surface antigen Negative for Hepatitis C viral sequences and antibody Availability for follow-up for planned duration of the study (12 months) Acceptable methods of contraception Exclusion Criteria Receipt of HIV vaccines or placebo in a previous HIV vaccine trial History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol History of suicide attempts, recent suicidal ideation, or psychosis High risk behavior for HIV infection as determined by screening questionnaire History of injection drug use within 12 months of study entry Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations. Use of experimental agents within 30 days of study entry Receipt of blood products or immunoglobulin within 6 months of study entry Active syphilis Active tuberculosis History of anaphylaxis or serious adverse reactions to vaccines History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension) Pregnant or breastfeeding
Sites / Locations
- Institute of Human Virology
Arms of the Study
Arm 1
Experimental
1
All participants will receive oral vaccine at study entry, although dosage will vary