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Safety of and Immune Response to an HIV-1 DNA Vaccine (VRC HIVDNA009-00-VP) 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: NCT00071851
Recruitment Status : Completed
First Posted : November 5, 2003
Last Update Posted : April 10, 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 and immune response to an HIV-1 vaccine, VRC-HIVDNA009-00-VP, in HIV uninfected participants. Two different doses of the vaccine will be tested.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: VRC-HIVDNA009-00-VP Phase 1 Phase 2

Detailed Description:

The worldwide HIV epidemic highlights the importance of developing an affordable, globally successful vaccine for HIV prevention. The VRC-HIVDNA009-00-VP vaccine used in this study was developed to incorporate HIV genes from multiple virus clades, representing the viral subtypes responsible for about 90% of new HIV infections in the world. The purpose of this study is to determine the safety and immunogenicity of VRC-HIVDNA009-00-VP in healthy, HIV uninfected individuals.

Participants will be randomly assigned to one of three groups and will be followed for one year. Study injections will be given by needle-free intramuscular injection at the start of study and at Months 1 and 2. Group 1 will receive 3 injections of the study vaccine; Group 2 will receive 2 injections of the study vaccine (at start and Month 2) and injection of placebo (at Month 1); Group 3 will receive 3 injections of placebo. After a screening visit, study visits will occur at enrollment (initial injection) followed by 5 visits every 14 days for the first 2.5 months, with three additional visits at Months 6, 9, and 12. All participants will undergo physical exams, blood and urine tests to assess measures of health, and blood tests to assess HIV infection and immune response to the injections.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase IB Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP, Administered at 2 Different Dosing Schedules, in HIV-1-Uninfected Adult Participants
Study Start Date : December 2003
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Understanding of vaccination procedure
  • Willing to receive HIV test results and provide informed consent
  • Good general health
  • HIV negative
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
  • Not pregnant and agrees to use acceptable forms of contraception

Exclusion Criteria

  • HIV vaccines or placebo in a prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to study
  • Blood products within 120 days prior to study
  • Immunoglobulin within 60 days prior to study
  • Live attenuated vaccines within 30 days prior to study
  • Investigational research agents within 30 days prior to study
  • Medically indicated subunit or killed vaccines within 14 days prior to study
  • Current anti-tuberculosis prophylaxis or therapy
  • Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection
  • Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
  • Diabetes mellitus; a participant with past gestational diabetes is not excluded
  • Thyroid disease, including removal of thyroid and diagnoses requiring medication
  • Serious angioedema
  • Hypertension
  • Diagnosis of bleeding disorder
  • Malignancy, except those with a surgical excision and subsequent observation period that in the investigator's estimate has a reasonable assurance of sustained cure and/or is unlikely to recur during the period of the study
  • Seizure disorder requiring medication within the last 3 years
  • Absence of the spleen
  • Mental illness that would interfere with compliance with the protocol
  • Pregnant or breastfeeding
  • Two or more elevated liver function tests

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): NCT00071851

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United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States, 94102
United States, Maryland
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States, 21205
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, Missouri
Saint Louis Univ. School of Medicine, HVTU
St. Louis, Missouri, United States, 63110
United States, New York
NY Blood Ctr./Bronx CRS
Bronx, New York, United States, 10455
NY Blood Ctr./Union Square CRS
New York, New York, United States, 10003
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Julie McElrath Fred Hutchinson Cancer Research Center / University of Washington
Study Chair: Larry Peiperl San Francisco Department of Public Health / University of California - San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00071851    
Other Study ID Numbers: HVTN 052
10198 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: November 5, 2003    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Seronegativity
HIV Preventive Vaccine
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