A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

NCT00000845 | Completed Phase 1

• 1 other identifier: AVEG 021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.

Conditions

HIV Infections

Keywords

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

Interventions

P3C541b Lipopeptide 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.
• One or more HLA alleles:
• A33, B8, B27, B35, or Bw62.
• Negative for Hepatitis B surface antigen.
• Normal urine dipstick.
• Normal history and physical examination.
• Availability for follow-up planned duration of the study (12 months).
• Viable EBV line prior to enrollment.
• Risk behavior: Required:
• Lower 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 (e.g., recent suicidal ideation or present psychosis).
• Active syphilis. NOTE: If the serology is documented to be false positive due to a remote (\> 6 months) treated infection, the volunteer is eligible.
• Hepatitis B surface antigenemia.
• 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, autoimmune disease.
• History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of a cure.
• History of anaphylaxis or history of other serious adverse reactions to vaccines.
• History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care.
• History of suicide attempts or past psychosis.
• Prior Medication:
• Excluded:
• History of use of immunosuppressive medication.

Sponsors & Collaborators

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

Study Sites (3)

Johns Hopkins Univ / School of Hygiene & Public Health

Baltimore, Maryland, 212051901, United States

Location

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, 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

• Schwartz D

  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)