- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000846
A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.
Study Overview
Status
Completed
Conditions
Detailed Description
After the prescreening, volunteers will be randomized into Group I or Group II.
Each group will contain 16 volunteers.
At least 5 volunteers in each group must be women.
At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo.
Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh.
At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo.
Follow up will be conducted.
Study Type
Interventional
Enrollment
36
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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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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New York
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Rochester, New York, United States, 14642
- Univ of Rochester Med Ctr
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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.
- Negative for Hepatitis B surface antigen.
- Normal urine dipstick.
- Normal history and physical exam.
- Availability for follow-up for planned duration of the study (60 weeks).
Risk Behavior: Required:
- Lower or intermediate 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.
- Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
- 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 or autoimmune disease.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy.
- History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months.
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.
- Receipt of blood products or immunoglobulin in the past 6 months.
- Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial.
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 to enrollment.
- Higher 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.
Investigators
- Study Chair: Mulligan M
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 023
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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