Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients

NCT ID: NCT00052182

Last Updated: 2007-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31

Brief Summary

HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.

Detailed Description

Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4 count of 350 cells/mm3 or more and fully suppressed viral replication on stable HAART.

Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomly assigned to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.

Conditions

HIV Infections

Keywords

HIV Therapeutic Vaccine; CTL Epitope; Treatment Experienced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Immunization on Day 0 and Weeks 4, 8, and 16

Group Type: EXPERIMENTAL

EP HIV-1090

Intervention Type: BIOLOGICAL

Interventions

EP HIV-1090

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Documented HIV-1 infection
• Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
• Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
• CD4 count of 350 cells/mm3 or more within 30 days of entry

Exclusion Criteria

• Immunomodulatory agents
• Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
• Hepatitis B surface antigen or hepatitis C virus antibody positive

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

Constance Benson, MD

Role: STUDY_CHAIR

University of California, San Diego

Locations

University of Colorado, Health Science Center

Denver, Colorado, United States

Countries

United States

References

Wilson CC, McKinney D, Anders M, MaWhinney S, Forster J, Crimi C, Southwood S, Sette A, Chesnut R, Newman MJ, Livingston BD. Development of a DNA vaccine designed to induce cytotoxic T lymphocyte responses to multiple conserved epitopes in HIV-1. J Immunol. 2003 Nov 15;171(10):5611-23. doi: 10.4049/jimmunol.171.10.5611.

Reference Type: BACKGROUND

PMID: 14607970 (View on PubMed)

Other Identifiers

IPCP 01

Identifier Type: -

Identifier Source: secondary_id

P01AI048238-03

Identifier Type: NIH

Identifier Source: org_study_id

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