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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000845
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 2002

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00000845 on ClinicalTrials.gov Archive Site
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A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Biological: P3C541b Lipopeptide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000845
AVEG 021
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Schwartz D
National Institute of Allergy and Infectious Diseases (NIAID)
October 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP