A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.

Trial Officials