Completed

A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

HIV-1 Peptide Immunogen, Multivalent

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: September 9, 2008
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: September 9, 2008
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
28 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 Subjects must have: * Normal history and physical exam. * HIV negativity by ELISA within 8 weeks of immunization. * CD4 count \>= 400 cells/mm3. * Normal urinalysis. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: * Positive hepatitis B surface antigen. * Medical or psychiatric condition or occupational responsibilities that preclude study compliance. * Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible. * Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, or autoimmune disease. * History of anaphylaxis or other serious reactions to vaccines. Prior Medication: Excluded: * History of immunosuppressive medications. * Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization). * Experimental agents within 30 days prior to study entry. * Prior HIV vaccines. Prior Treatment: Excluded: * Blood products or immunoglobulin within the past 6 months. Identifiable higher risk behavior for HIV infection, including the following: * History of injection drug use within the past 12 months. * Higher risk sexual behavior as defined by the 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 1 location
Suspended
Johns Hopkins Univ / Ctr for Immunological ResearchBaltimore, United StatesSee the location

CompletedOne Study Center