Search / Trial NCT00000845

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 09, 2024

Completed

Keywords

Vaccines, Synthetic Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.

Trial Officials

Schwartz D

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Baltimore, Maryland, United States

Seattle, Washington, United States

Nashville, Tennessee, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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