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.

HIV Infections Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000846
• Other study ID #: AVEG 023
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 2002
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HIV-1 Peptide Vaccine, Microparticulate Monovalent

• HIV-1 Peptide Immunogen, Multivalent

Locations

Country	Name	City	State
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Univ of Rochester Med Ctr	Rochester	New York
United States	Univ of Washington / Pacific Med Ctr	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,