This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil) against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males...
Date First Received: April 22, 2008
Last Updated: June 3, 2008
Verified by: Southern California Institute for Research and Education, June 2008
Clinical Trial Phase: N/A | Start Date: June 2008
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-Infected Men”
Condition Keyword(s):
Intervention(s):
This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil) against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.
Study Type: Interventional
Study Design: Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: December 2009
Detailed Clinical Trial Description
This is a prospective pilot study that will attempt to enroll approximately 150-200 HIV-infected males followed regularly in the ID Primary Care Clinic at the VA Long Beach Healthcare System. All consenting patients will be given the HPV vaccine (Gardasil) in three intramuscular injections. Baseline antibody titers to HPV strains 16 and 18 will be obtained at day 0 and repeat levels will be obtained approximately 8 weeks after the completion of the vaccination series to determine whether patients without antibodies at baseline have now produced antibodies, or to determine the change in antibody levels in those patients who have evidence of antibodies prior to the first injection of the vaccine. Patients will undergo routine anal PAP smear with HPV DNA testing at baseline and another PAP smear/HPV test approximately 8 weeks after completion of the series. Patients will report any side effects of the vaccine to the PI. Patients will have blood work to monitor HIV-1 viral load and CD4 lymphocytes counts at various points during the study.
Intervention(s) in this Clinical Trial
- Biological: Gardasil
- Intramuscular injections of Gardasil at Day 0, Month 2 and at Month 6
Outcome Measures for this Clinical Trial
Primary Measures
- Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies
- Time Frame: nine months
Safety Issue?: No
- Time Frame: nine months
- Determine percentage of subjects who seroconverted or mounted a significant serologic response to each of the 2 antigens 16 and 18
- Time Frame: 8-9 months
Safety Issue?: No
- Time Frame: 8-9 months
- Determine how many patients, if any, develop evidence of anal HPV infection, as measured by development of a positive HPV test.
- Time Frame: 9 months
Safety Issue?: No
- Time Frame: 9 months
- Determine if vaccinations will activate the subject's immune systems sufficiently that the HIV-1 viral load either increases from the baseline value, or becomes detectable and stays detectable after being undetectable at the baseline visit
- Time Frame: nine months
Safety Issue?: Yes
- Time Frame: nine months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male veterans
- Age 18 or older
- HIV-positive
- Seen regularly in the ID Primary Care Clinic at the VA Long Beach Healthcare System
Exclusion Criteria:
- None
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Southern California Institute for Research and Education
Overall Clinical Trial Officials and Contacts
Stephen M Berman, M.D., Ph.D. Principal Investigator Southern California Institute for Research and Education
Overall Contact: Stephen M Berman, M.D., Ph.D. (562) 826-8000 stephen.berman2@va.gov
Related Publications
References
Chin-Hong PV, Palefsky JM. Natural history and clinical management of anal human papillomavirus disease in men and women infected with human immunodeficiency virus. Clin Infect Dis. 2002 Nov 1;35(9):1127-34. Epub 2002 Oct 14.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27.
Emeny RT, Wheeler CM, Jansen KU, Hunt WC, Fu TM, Smith JF, MacMullen S, Esser MT, Paliard X. Priming of human papillomavirus type 11-specific humoral and cellular immune responses in college-aged women with a virus-like particle vaccine. J Virol. 2002 Aug;76(15):7832-42.
Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8.
Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Høye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. Epub 2007 Apr 20.
Bower M, Powles T, Newsom-Davis T, Thirlwell C, Stebbing J, Mandalia S, Nelson M, Gazzard B. HIV-associated anal cancer: has highly active antiretroviral therapy reduced the incidence or improved the outcome? J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1563-5.
Bozzette SA, Phillips B, Asch S, Gifford AL, Lenert L, Menke T, Oritz E, Owens D, Deyton L. Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Med Care. 2000 Jun;38(6 Suppl 1):I60-9. Review.
Additional Information
Information obtained from ClinicalTrials.gov on August 21, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666107
Study ID Number: #33245
ClinicalTrials.gov Identifier: NCT00666107
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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