Safety of and Immune Response to an HIV Vaccine (VRC-HIVDNA009-00-VP) Administered With Interleukin-2/Immunoglobulin (IL-2/Ig) DNA Adjuvant in 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: NCT00069030
Recruitment Status : Completed
First Posted : September 16, 2003
Last Update Posted : November 8, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

This study will test the safety of and immune system response to a new HIV vaccine. The vaccine in this study is made from HIV DNA produced in a laboratory. Only part of the virus's DNA is used in the vaccine and the vaccine itself cannot cause HIV infection or AIDS. In addition to HIV DNA, the vaccine contains interleukin-2 (IL-2) DNA fused to a portion of immunoglobulin (Ig) DNA. IL-2 is a chemical that stimulates the immune system and may improve response to the vaccine.

Study hypothesis: The IL-2/Ig plasmid will be very well tolerated in humans.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade-Env) with adjuvant VRC-ADJDNA004-IL2-VP Phase 1

Detailed Description:

Over 90% of the 40 million people infected with HIV live in developing countries and have little or no access to antiretroviral medications. The worldwide HIV/AIDS epidemic will only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. The DNA vaccine in this study, VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade Env), uses multiple gene products to increase the breadth of the immune response across different HIV subtypes. The DNA plasmids in VRC-HIVDNA009-00-VP code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world.

The study vaccine is administered with an adjuvant. The adjuvant is a DNA plasmid encoding interleukin 2 (IL-2) fused to the Fc portion of IgG for enhanced stability. This IL-2/Ig adjuvant may augment the immune system's response to the vaccine.

Participants in this study will be randomly assigned to receive either the vaccine and adjuvant, the vaccine and placebo, the adjuvant and placebo, or placebo alone. All injections will be administered by needle-free injection in the upper arm. Participants will receive four does of vaccine: one at their first study visit and then at Months 1, 2, and 6. Participants will have a follow-up visit 2 days after each injection. Some participants may receive another injection at this follow-up visit. All study participants will be followed for 18 months and will have 16 to 20 study visits. Study visits will last 1/2 to 2 hours and will include blood and urine tests and a physical exam. Participants will also have six HIV tests over the course of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP (Gag-Pol-Nef-multiclade Env) With the Plasmid Cytokine Adjuvant VRC-ADJDNA004-IL2-VP (IL-2/Ig)
Study Start Date : December 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Clinical observation and monitoring of hematological, chemical, and immunologic parameters
  2. local and systemic adverse reactions after each injection and for 12 months after last injection

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
  • 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
  • Normal thyroid stimulating hormone (TSH) level

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
  • Clinical depression with pharmacological treatment within the past 2 years
  • 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 judgement 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): NCT00069030

United States, Maryland
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
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, 02215
United States, New York
NY Blood Ctr./Bronx CRS
Bronx, New York, United States, 10456
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Raphael Dolin, MD Harvard Medical School

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00069030     History of Changes
Other Study ID Numbers: HVTN 044
5K08AI051223-03 ( U.S. NIH Grant/Contract )
10120 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: September 16, 2003    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine
AIDS Vaccines
Vaccines, DNA
Dose-Response Relationship, Immunologic
Adjuvants, Immunologic
Drug Administration Schedule

Additional relevant MeSH terms:
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