Clinical trial NCT00000845: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
Official title: A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Univ / School of Hygiene & Public Health
state: Maryland
city: Nashville
country: United States
facility: Vanderbilt Univ Hosp
state: Tennessee
city: Seattle
country: United States
facility: Univ of Washington / Pacific Med Ctr
state: Washington
Study officials:
name: Schwartz D
role: STUDY_CHAIR
References: