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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) HIV Vaccine Trials Network Dale and Betty Bumpers Vaccine Research Center |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00384787 |
The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously).
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.
Condition | Intervention | Phase |
HIV Infections |
Biological: VRC-HIVDNA009-00-VP Biological: VRC-HIVADV014-00-VP |
Phase I |
MedlinePlus related topics: | AIDS |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase Ib Clinical Trial to Compare the Safety, Tolerability, and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly, Intradermally, or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults |
Estimated Enrollment: | 90 |
Study Start Date: | March 2006 |
Arms | Assigned Interventions |
1: Experimental
Group 1 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intramuscularly at Month 6.
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Biological: VRC-HIVDNA009-00-VP
HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
Biological: VRC-HIVADV014-00-VP
Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
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2: Experimental
Group 2 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intradermally at Month 6.
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Biological: VRC-HIVDNA009-00-VP
HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
Biological: VRC-HIVADV014-00-VP
Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
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3: Experimental
Group 3 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost subcutaneously at Month 6.
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Biological: VRC-HIVDNA009-00-VP
HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
Biological: VRC-HIVADV014-00-VP
Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
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One factor that may affect safety and immunogenicity to an HIV vaccine is the route of vaccine administration. Administration into the skin (intradermal) or subcutaneous tissue may be more immunogenic or provide a different pattern of immune responses than administration by the intramuscular route. Previous studies with other preventive vaccines suggest that the resulting immunogenicity following intradermal or subcutaneous vaccine administration is comparable or better than immunogenicity observed following intramuscular administration. Increased immunogenicity though use of a particular route will likely result in greater demonstrated efficacy, requiring fewer or lower doses of vaccine to elicit a sufficient immune response.
The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity when given intramuscularly and has appeared safe and well tolerated in prior vaccine trials in HIV uninfected adults. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C. This study will evaluate the safety, immunogenicity, and tolerability to a DNA HIV vaccine, followed by an adenoviral vaccine boost given either intramuscularly, intradermally, or subcutaneously, in HIV uninfected adults.
All participants will receive three doses of the DNA vaccine intramuscularly at study entry and Months 1 and 2. Participants will be randomly assigned to one of three groups, differing by how they will receive the adenoviral vaccine boost:
This study will last 1 year. There will be 12 study visits; a physical exam, medication history, and risk reduction/pregnancy prevention compliance counseling will occur at all visits. Urine and blood collection will occur at selected visits. Participants will be asked to complete a social impact assessment at Months 2, 6, and 12 and an outside testing and belief questionnaire at Months 6 and 12. Participants will be asked to record their temperature and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects.
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
University of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294-2041 | |||||
United States, Massachusetts | |||||
Harvard Medical School/Brigham & Womens Hospital | |||||
Boston, Massachusetts, United States, 02115 | |||||
United States, New York | |||||
New York Blood Center - Union Square | |||||
New York, New York, United States, 10003 | |||||
New York Blood Center - Bronx | |||||
Bronx, New York, United States, 10456 | |||||
Columbia University | |||||
New York, New York, United States, 10032 | |||||
United States, Washington | |||||
FHCRC/UW - Vaccine Trials Unit | |||||
Seattle, Washington, United States, 98104 | |||||
Peru, Loreto | |||||
Asociacion Civil Selva Amazonica | |||||
Iquitos, Loreto, Peru |
National Institute of Allergy and Infectious Diseases (NIAID) |
HIV Vaccine Trials Network |
Dale and Betty Bumpers Vaccine Research Center |
Study Chair: | Beryl Koblin, PhD | New York Blood Center |
Study Chair: | Martin Casapia, MD | Asociación Civil Impacta Salud y Educación (IMPACTA), Peru |
Click here for more information about preventive HIV vaccines 
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Haga clic aquí para ver información sobre este ensayo clínico en español 
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Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HVTN 069 |
First Received: | October 4, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00384787 |
Health Authority: | United States: Food and Drug Administration |
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