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
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00000845     History of Changes
Other Study ID Numbers: AVEG 021
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014