HIV Infections
Conditions
Keywords
Vaccines, Synthetic, HIV-1, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Brief summary
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
Detailed description
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Patients must have or be: * Healthy. * Negative ELISA for HIV. * Negative for Hepatitis B surface antigen. * Normal urine dipstick. * Normal history and physical exam. * Availability for follow-up for planned duration of the study (60 weeks). Risk Behavior: Required: * Lower or intermediate risk sexual behavior as defined by AVEG.
Exclusion criteria
Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: * Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. * Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (\> 6 months) treated infection, the volunteer is eligible. * Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible. Patients with any of the following prior conditions are excluded: * History of immunodeficiency, chronic illness, malignancy or autoimmune disease. * History of anaphylaxis or other serious adverse reactions to vaccines. * History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy. * History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months. Prior Medication: Excluded: * History of use of immunosuppressive medication. * Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed 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 prior to study. * Receipt of blood products or immunoglobulin in the past 6 months. * Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial. Risk Behavior: Excluded: * Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection. * History of injection drug use within the last 12 months to enrollment. * Higher risk sexual behavior as defined by AVEG.
Countries
United States
Outcome results
None listed