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.

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent; Biological: HIV-1 Peptide Immunogen, Multivalent

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000846

AVEG 023

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.