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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000845
• Other study ID #: AVEG 021
• 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 an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.

Description:

The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants have reached day 14 without serious adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• 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.

• 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.

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 (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.

• 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.

Prior Treatment:

Excluded:

• Receipt of blood products or immunoglobulin in the past 6 months.

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 prior to enrollment.

• Higher or intermediate 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:
• P3C541b Lipopeptide

Locations

Country	Name	City	State
United States	Johns Hopkins Univ / School of Hygiene & Public Health	Baltimore	Maryland
United States	Vanderbilt Univ Hosp	Nashville	Tennessee
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,