Completed

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

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What is being tested

P3C541b Lipopeptide

Biological
Who is being recruted

HIV Infections

From 18 to 60 Years
How is the trial designed

Prevention Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
30 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Johns Hopkins Univ / School of Hygiene & Public HealthBaltimore, United StatesSee the location
Suspended
Vanderbilt Univ HospNashville, United States
Suspended
Univ of Washington / Pacific Med CtrSeattle, United States

Completed3 Study Centers