Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000845
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: P3C541b Lipopeptide
Phase I

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Double-Blind, Safety Study
Official Title: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 30
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000845

Locations
United States, Maryland
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, United States, 212051901
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
United States, Washington
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Investigators
Study Chair: Schwartz D
  More Information

Study ID Numbers: AVEG 021
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000845  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009