Safety of and Immune Response to Two Different HIV Vaccines, Each Followed by a Adenoviral Vaccine Boost, in HIV Uninfected Adults
NCT ID: NCT00270218
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
66 participants
INTERVENTIONAL
2006-02-28
2007-08-31
Brief Summary
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Detailed Description
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This study will last 1 year. Participants will be randomly assigned to one of two groups. Within each group, participants will be randomly assigned to receive either vaccine or control injections. Group 1 participants will receive either placebo or the adenoviral HIV vaccine at study entry and Month 6. Group 2 participants will receive either placebo or the DNA HIV vaccine at study entry and Month 1 and the adenoviral HIV vaccine at Month 6. Participants will be asked to record their temperatures and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects.
Group 1 participants will have 16 study visits, and a physical exam and HIV and pregnancy prevention counseling will occur at each visit. Participants will also be asked about any side effects and medications they are taking. Blood collection will occur at most visits. Urine collection will occur at selected visits. Participants will be asked to complete a social impact assessment at Months 2, 6, and 12 and a testing and belief questionnaire at Months 6 and 12.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Arm 1 participants will be given an injection of VRC-HIVADV014-00-VP vaccine on Days 0 and 168.
VRC-HIVADV014-00-VP
HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid
2
Arm 2 participants will be given an injection of final formulation buffer (FFB) on Days 0 and 168.
FFB
Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid
3
Arm 3 participants will be given an injection of VRC-HIVDNA009-00-VP vaccine on Days 0 and 28. Participants will also be given an injection of VRC-HIVADV014-00-VP on Day 168.
VRC-HIVADV014-00-VP
HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid
VRC-HIVDNA009-00-VP
HIV-1 DNA plasmid vaccine given as a 1 mL intramuscular injection in the deltoid
4
Arm 4 participants will be given an injection of phosphate buffered saline (PBS) on Days 0 and 28 and an injection of FFB on Day 168.
FFB
Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid
PBS
phosphate buffered saline
Interventions
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VRC-HIVADV014-00-VP
HIV-1 recombinant adenoviral vector vaccine given as a 1 mL intramuscular injection in the deltoid
VRC-HIVDNA009-00-VP
HIV-1 DNA plasmid vaccine given as a 1 mL intramuscular injection in the deltoid
FFB
Adenoviral vector FFB given as a 1 mL intramuscular injection in the deltoid
PBS
phosphate buffered saline
Eligibility Criteria
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Inclusion Criteria
* Good general health
* Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of less than a 1:12 ratio
* Hepatitis B surface antigen negative
* Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
* Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
* Willing to receive HIV test results
* Understand the vaccination procedure
* Willing to use acceptable forms of contraception
Exclusion Criteria
* Immunosuppressive medications within 168 days prior to first study vaccination
* Blood products within 120 days prior to first study vaccination
* Live attenuated vaccines within 30 days prior to first study vaccination
* Investigational research agents within 30 days prior to first study vaccination
* Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
* Current anti-tuberculosis (TB) preventive therapy or treatment
* 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. More information about this criterion can be found in the protocol.
* Any job-related responsibility that would interfere with the study
* Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
* Autoimmune disease or immunodeficiency
* Active syphilis infection. Participants who have been fully treated for syphilis for more than 6 months prior to study entry are not excluded.
* Moderate to severe asthma. More information on this criterion can be found in the protocol.
* Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
* Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
* Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
* Uncontrolled hypertension
* Body mass index (BMI) of 40 or greater OR BMI of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol.
* Bleeding disorder
* Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
* Seizure disorder
* Absence of the spleen
* Mental illness that would interfere with the study
* Pregnancy or breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Stephen De Rosa, MD
Role: STUDY_CHAIR
Fred Hutchinson Cancer Research Center and University of Washington
Spyros A. Kalams, MD
Role: STUDY_CHAIR
Vanderbilt University
Locations
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Alabama Vaccine CRS
Birmingham, Alabama, United States
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
NY Blood Ctr./Union Square CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Univ. of Rochester HVTN CRS
Rochester, New York, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
FHCRC/UW Vaccine 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.
De Rosa SC, Lu FX, Yu J, Perfetto SP, Falloon J, Moser S, Evans TG, Koup R, Miller CJ, Roederer M. Vaccination in humans generates broad T cell cytokine responses. J Immunol. 2004 Nov 1;173(9):5372-80. doi: 10.4049/jimmunol.173.9.5372.
Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
Vanniasinkam T, Ertl HC. Adenoviral gene delivery for HIV-1 vaccination. Curr Gene Ther. 2005 Apr;5(2):203-12. doi: 10.2174/1566523053544236.
Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
Other Identifiers
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10060
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 068
Identifier Type: -
Identifier Source: org_study_id