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

September 8, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

28

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Univ / Ctr for Immunological Research

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

No

Genders Eligible for Study

All

Description

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 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.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Keefer M

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

October 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVEG 017

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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