- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000845
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Study Overview
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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 212051901
- Johns Hopkins Univ / School of Hygiene & Public Health
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Univ Hosp
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Washington
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Seattle, Washington, United States, 98144
- Univ of Washington / Pacific Med Ctr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
October 1, 2002
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVEG 021
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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