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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054860
Recruitment Status : Completed
First Posted : February 13, 2003
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: EP HIV-1090 Phase 1

Detailed Description:

Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T lymphocyte (CTL) responses contribute to control and clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for protection against HIV infection and disease progression. EP HIV-1090 is a DNA vaccine composed of 21 highly specific CTL epitopes. The vaccine is designed to optimize the immune response in people expressing one of three HLA Class I antigen subtypes: HLA-A2, -A3, and -B7. This design is predicted to induce an immune response in 85% of individuals in the general population. There is also a helper T lymphocyte (HTL) facilitating epitope (PADRE) in the vaccine. The vaccine is formulated with a water soluble polymer (polyvinylpyrrolidone) that protects the DNA and facilitates cellular uptake. This study will assess the safety of and immune response to different doses of EP HIV-1090 in healthy, HIV uninfected adults.

Participants in this study will be randomized to receive either one of three different doses of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular injection. Participants will be followed for 18 months and will have 12 study visits. Each study visit will include a physical exam, medical history, and blood and urine tests. Each participant will have four HIV tests during the study. Women will have at least five pregnancy tests during the study.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase I Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of the EP HIV-1090 DNA Vaccine in Healthy, HIV-1-Uninfected Adult Participants
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • HIV negative
  • Positive for one or more of the following HLA supertypes: -A2, -A3, or -B7
  • Willing to receive HIV test results
  • Good general health
  • Acceptable methods of contraception for females of reproductive potential
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive

Exclusion Criteria

  • HIV vaccines or placebos in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Active syphilis
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Unstable asthma
  • Type 1 or Type 2 Diabetes Mellitus
  • Thyroid disease requiring treatment
  • Serious angioedema within the past 3 years
  • Uncontrolled hypertension
  • Bleeding disorder
  • Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
  • Seizure disorder requiring medication within the past 3 years
  • Asplenia
  • Mental illness that would interfere with compliance with the protocol
  • Other conditions that, in the judgment of the investigator, would interfere with the study
  • Pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054860

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United States, Massachusetts
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis Univ. School of Medicine, HVTU
St. Louis, Missouri, United States, 63110
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
Gaborone Prevention/Treatment Trials CRS
Gaborone, Botswana
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Geoffrey J. Gorse, MD St. Louis University


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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00054860     History of Changes
Other Study ID Numbers: HVTN 048
10197 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: February 13, 2003    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
HIV Seronegativity
AIDS Vaccines
Vaccines, DNA
Dose-Response Relationship, Immunologic
CD4-Positive T-Lymphocytes
CD8-Positive T-Lymphocytes
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs