Safety of and Immune Response to a DNA HIV Vaccine Followed By Boosting With One of Two Serotypes of Adenoviral Vector HIV Vaccine in Healthy Adults
NCT ID: NCT00472719
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2007-08-31
2013-01-31
Brief Summary
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Detailed Description
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Each volunteer will participate in the study for at least 6 months. Participants will be randomly assigned to one of four groups and will receive either an experimental vaccine or placebo at each vaccination visit. Group 1 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00-VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. Group 2 participants will receive an injection of the adenoviral vector vaccine VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. Group 3 participants will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VP at Month 6. Group 4 participants will receive an injection of the DNA HIV vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6.
For Groups 1 and 2, there will be 9 study visits. For Groups 3 and 4, there will be 13 study visits. Medication history, assessment of intercurrent illness and adverse effects, and HIV and pregnancy prevention counseling will occur at all visits. A medical history, a physical exam, HIV testing and counseling and blood and urine collection will occur at selected visits. Participants will also be asked to complete social impact and HIV testing and history questionnaires at selected visits.
As of 11/19/07 enrollment and vaccinations have been discontinued. Participants who have already been enrolled have been told which vaccinations they received and will be followed for a total of 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Participants in this group will receive an injection of the adenoviral vector vaccine VRC-HIVADV027-00VP at study entry and an injection of VRC-HIVADV038-00-VP at Month 3. There will be 9 study visits for this arm.
VRC-HIVADV027-00-VP
Adenoviral vector booster vaccine
VRC-HIVADV038-00-VP
Adenovirus vector booster vaccine
2
Participants in this group will receive an injection of VRC-HIVADV038-00-VP at study entry and an injection of VRC-HIVADV027-00-VP at Month 3. There will be 9 study visits for this group.
VRC-HIVADV027-00-VP
Adenoviral vector booster vaccine
VRC-HIVADV038-00-VP
Adenovirus vector booster vaccine
3
Participants in this group will receive an injection of the VRC-HIVDNA044-00-VP vaccine at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV027-00-VPat Month 6. There will be 13 study visits for this group.
VRC-HIVADV027-00-VP
Adenoviral vector booster vaccine
VRC-HIVDNA044-00-VP
Experimental, multiclade, multigene HIV DNA vaccine
4
Participants in this group will receive an injection of VRC-HIVDNA044-00-VP at study entry and Months 1 and 2, followed by an injection of VRC-HIVADV038-00-VP at Month 6. There will be 13 study visits for this group.
VRC-HIVADV038-00-VP
Adenovirus vector booster vaccine
VRC-HIVDNA044-00-VP
Experimental, multiclade, multigene HIV DNA vaccine
Interventions
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VRC-HIVADV027-00-VP
Adenoviral vector booster vaccine
VRC-HIVADV038-00-VP
Adenovirus vector booster vaccine
VRC-HIVDNA044-00-VP
Experimental, multiclade, multigene HIV DNA vaccine
Eligibility Criteria
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Inclusion Criteria
* Have access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
* Willing to receive HIV test results
* Good general health
* Pre-existing adenovirus 5 (Ad5) neutralizing antibody titer of 1:1000 ratio or greater
* Willing to use acceptable forms of contraception from at least 21 days prior to enrollment through the duration of the study
Exclusion Criteria
* 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 anti-tuberculosis prophylaxis or therapy
* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
* Any medical, psychiatric, or social condition that would interfere with the study.
* Serious adverse reaction to vaccines. Participants who have had an adverse reaction to pertussis vaccine as a child are not excluded.
* Autoimmune disease or immunodeficiency
* Active syphilis infection. Participants with fully treated syphilis at least 6 months prior to study entry are not excluded.
* Unstable asthma. More information about this criterion can be found in the protocol.
* Diabetes mellitus type 1 or 2. Participants with a history of isolated gestational diabetes are not excluded.
* Absence of thyroid or thyroid disease requiring treatment
* Serious angioedema within the past 3 years or requiring medication within 2 years of study entry
* Body mass index (BMI) of 40 or less OR BMI of 35 or less if certain other criteria apply. More information about these criteria can be found in the protocol.
* Uncontrolled hypertension
* Bleeding disorder
* Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
* Seizure disorder
* Absence of spleen
* Certain abnormal laboratory values
* 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 breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
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HIV Vaccine Trials Network
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jonathan Fuchs, MD, MPH
Role: STUDY_CHAIR
San Francisco Department of Public Health, University of California, San Francisco
Locations
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Alabama Vaccine CRS
Birmingham, Alabama, United States
Bridge HIV CRS
San Francisco, California, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Countries
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References
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Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
Barouch DH, Pau MG, Custers JH, Koudstaal W, Kostense S, Havenga MJ, Truitt DM, Sumida SM, Kishko MG, Arthur JC, Korioth-Schmitz B, Newberg MH, Gorgone DA, Lifton MA, Panicali DL, Nabel GJ, Letvin NL, Goudsmit J. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J Immunol. 2004 May 15;172(10):6290-7. doi: 10.4049/jimmunol.172.10.6290.
Cohen P. Immunity's yin and yang. A successful vaccine must first avoid being eliminated by pre-existing immunity before it can promote a protective immune response. IAVI Rep. 2006 Jan-Feb;10(1):1-5. No abstract available.
Lemckert AA, Sumida SM, Holterman L, Vogels R, Truitt DM, Lynch DM, Nanda A, Ewald BA, Gorgone DA, Lifton MA, Goudsmit J, Havenga MJ, Barouch DH. Immunogenicity of heterologous prime-boost regimens involving recombinant adenovirus serotype 11 (Ad11) and Ad35 vaccine vectors in the presence of anti-ad5 immunity. J Virol. 2005 Aug;79(15):9694-701. doi: 10.1128/JVI.79.15.9694-9701.2005.
Wu L, Kong WP, Nabel GJ. Enhanced breadth of CD4 T-cell immunity by DNA prime and adenovirus boost immunization to human immunodeficiency virus Env and Gag immunogens. J Virol. 2005 Jul;79(13):8024-31. doi: 10.1128/JVI.79.13.8024-8031.2005.
Other Identifiers
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10517
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 072
Identifier Type: -
Identifier Source: org_study_id