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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000845

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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