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.

NCT00000846 | Completed Phase 1

• 1 other identifier: AVEG 023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; HIV-1; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

HIV-1 Peptide Vaccine, Microparticulate Monovalent BIOLOGICAL

HIV-1 Peptide Immunogen, Multivalent BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of experimental agents within 30 days prior to study.
• Receipt of blood products or immunoglobulin in the past 6 months.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Univ of Washington / Pacific Med Ctr

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mulligan M

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-10

Locations

US (3)