A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
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ClinicalTrials.gov Identifier: NCT00000795 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: September 9, 2008
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Tracking Information | ||||
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First Submitted Date ICMJE | November 2, 1999 | |||
First Posted Date ICMJE | August 31, 2001 | |||
Last Update Posted Date | September 9, 2008 | |||
Study Start Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00000795 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects | |||
Official Title ICMJE | A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects | |||
Brief Summary | To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates. Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics. |
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Detailed Description | Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics. Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine. At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and patients are followed for a minimum of 48 weeks after the initial immunization. Approximately 13 clinical visits are required. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE | Biological: HIV-1 Peptide Immunogen, Multivalent | |||
Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
28 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria Subjects must have:
Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded:
Identifiable higher risk behavior for HIV infection, including the following:
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Sex/Gender |
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Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00000795 | |||
Other Study ID Numbers ICMJE | AVEG 017 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Verification Date | October 2002 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |