Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
NCT ID: NCT00119873
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
48 participants
INTERVENTIONAL
2006-10-31
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. At study entry, participants in each group will receive a single injection of either one of two doses of the adenoviral vector vaccine or placebo. Participants will record their temperature and other side effects in a symptom log on the day of vaccination and for 3 days thereafter. Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy prevention counseling, and blood and urine collection will occur at each visit. Participants will also be asked about side effects they may be experiencing and medications they are taking.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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VRC-HIVADV014-00-VP
Eligibility Criteria
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Inclusion Criteria
* Willing to receive HIV test results
* Able to understand and comply with study requirements
* In good general health
* Have neutralizing adenovirus antibody levels that are less than a 1:12 ratio
* Agree to use acceptable methods of contraception for at least 21 days prior to study start and for the duration of the study.
Exclusion Criteria
* Positive hepatitis B surface antigen
* Positive anti-hepatitis C virus antibodies
* Prior receipt of an HIV vaccine
* Immunosuppressive drugs within 168 days prior to first vaccination
* Have received donated blood within 120 days prior to first vaccination
* Have received immunoglobulin within 60 days of the first vaccination
* Live attenuated vaccines or investigational research agents within 30 days prior to first vaccination
* Subunit or killed vaccines within 14 days prior to first vaccination
* Current preventive or therapeutic anti-tuberculosis (TB) treatment
* Any medical, psychiatric, or social condition that would interfere with the study
* Any occupational or other responsibility that would interfere with the study
* Serious adverse reactions to vaccines
* Autoimmune disease
* Immunodeficiency
* Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
* Asthma. Participants who have had completely resolved childhood asthma are not excluded.
* Diabetes mellitus type I or II. Participants who have had isolated gestational diabetes are not excluded.
* Thyroid disease or removal of the thyroid
* Blood vessel swelling within the last 3 years
* Uncontrolled hypertension
* Body mass index (BMI) of 40 or higher
* Bleeding disorder
* Cancer. Participants whose cancer has been removed and is unlikely to recur during the study are not excluded.
* Seizure disorder. Participants who have not required medication or had a seizure for 3 years prior to study entry are not excluded.
* Removal of the spleen or have a nonfunctioning spleen
* Psychiatric conditions that may interfere with the study
* Pregnancy, breastfeeding, or plan to become pregnant during the study
18 Years
50 Years
FEMALE
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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Laurence Peiperl, MD
Role: STUDY_CHAIR
San Francisco Department of Public Health
Locations
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San Francisco Vaccine and Prevention CRS
San Francisco, California, 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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Shiver J. A non-replicating adenoviral vector as a potential HIV vaccine. Res Initiat Treat Action. 2003 Spring;8(2):14-6.
Casimiro DR, Bett AJ, Fu TM, Davies ME, Tang A, Wilson KA, Chen M, Long R, McKelvey T, Chastain M, Gurunathan S, Tartaglia J, Emini EA, Shiver J. Heterologous human immunodeficiency virus type 1 priming-boosting immunization strategies involving replication-defective adenovirus and poxvirus vaccine vectors. J Virol. 2004 Oct;78(20):11434-8. doi: 10.1128/JVI.78.20.11434-11438.2004.
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.
Gomez-Roman VR, Robert-Guroff M. Adenoviruses as vectors for HIV vaccines. AIDS Rev. 2003 Jul-Sep;5(3):178-85.
Peiperl L, Morgan C, Moodie Z, Li H, Russell N, Graham BS, Tomaras GD, De Rosa SC, McElrath MJ; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of a replication-defective adenovirus type 5 HIV vaccine in Ad5-seronegative persons: a randomized clinical trial (HVTN 054). PLoS One. 2010 Oct 27;5(10):e13579. doi: 10.1371/journal.pone.0013579.
Other Identifiers
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10121
Identifier Type: REGISTRY
Identifier Source: secondary_id
HVTN 054
Identifier Type: -
Identifier Source: org_study_id