Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults
NCT ID: NCT01386164
Last Updated: 2013-08-16
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
PHASE4
92 participants
INTERVENTIONAL
2011-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Gardasil®
Gardasil
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Cervarix®
Cervarix
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Interventions
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Gardasil
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Cervarix
Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age above 18 at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Subjects whom the investigator believes can and will comply with the requirements of the protocol.
* If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.
Exclusion Criteria
* Pregnant or breastfeeding female.
* Previous enrollment in the study.
* Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
* Chronic administration of immunosuppressive drugs
* Cancer or autoimmune disease
* Previous allergic reaction to vaccination
* Known allergy towards on or more components of either of the test drugs.
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Lars Østergaard, MD,PhD,DmSC
Role: STUDY_DIRECTOR
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Lars Toft, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Locations
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Department of Infectious Diseases, Aarhus University Hospital
Aarhus N, , Denmark
Countries
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References
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Toft L, Tolstrup M, Muller M, Sehr P, Bonde J, Storgaard M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity of Cervarix(R) and Gardasil(R) human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults. Hum Vaccin Immunother. 2014;10(5):1147-54. doi: 10.4161/hv.27925. Epub 2014 Feb 19.
Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014 Apr 15;209(8):1165-73. doi: 10.1093/infdis/jit657. Epub 2013 Nov 23.
Other Identifiers
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LTN0001
Identifier Type: -
Identifier Source: org_study_id