Gardasil Vaccination in Post Stem Cell Transplant Patients

Summary

Background: * Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus (HPV), provides immunity to four types of HPV that are associated with genital warts and cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be highly effective in preventing infection with these HPV types and was approved for use by the Food and Drug Administration. * More research is needed about the vaccine s ability to induce immunity in individuals with suppressed immune systems, such as those who have had other kinds of cancer treatment such as stem cell transplant. Genital warts, precancer, and cancer have been reported as a late complication after stem cell transplant. Researchers are interested in determining whether the HPV vaccine is safe to give and able to induce immunity in female stem cell transplant recipients, their female donors, and healthy female volunteers. Objectives: \- To assess the safety and immune response of the HPV vaccine in female recipients of stem cell transplants who are either off or on stable doses of immunosuppression. Eligibility: * Females between 18 and 50 years of age who have had allogenic stem cell transplants. * Healthy female volunteers, including stem cell donors, are also eligible for this study. Design: * Participants will be screened with a physical examination, blood and urine tests, and saliva samples, and will be asked to complete a sexual quality of life questionnaire. * Sexually active participants will also have a routine gynecologic evaluation. * Participants will receive three HPV vaccinations according to the standard vaccination schedule (with the second and third following 2 and 6 months after the first). Participants will record their daily temperature and any reactions to the vaccine on a vaccine report card for 1 week after each vaccination. * Participants will have clinic visits for further testing 2, 6, 7, and 12 months after receiving the first HPV vaccine.

Timeline

Start

2010-06-02

Primary completion

2016-07-19

Completion

2016-07-19

Publications

• Background Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.
• Background Koutsky LA, Galloway DA, Holmes KK. Epidemiology of genital human papillomavirus infection. Epidemiol Rev. 1988;10:122-63. doi: 10.1093/oxfordjournals.epirev.a036020.
• Background Koshiol JE, Laurent SA, Pimenta JM. Rate and predictors of new genital warts claims and genital warts-related healthcare utilization among privately insured patients in the United States. Sex Transm Dis. 2004 Dec;31(12):748-52. doi: 10.1097/01.olq.0000145851.76025.ad.
• Stratton P, Battiwalla M, Tian X, Abdelazim S, Baird K, Barrett AJ, Cantilena CR, Childs RW, DeJesus J, Fitzhugh C, Fowler D, Gea-Banacloche J, Gress RE, Hickstein D, Hsieh M, Ito S, Kemp TJ, Khachikyan I, Merideth MA, Pavletic SZ, Quint W, Schiffman M, Scrivani C, Shanis D, Shenoy AG, Struijk L, Tisdale JF, Wagner S, Williams KM, Yu Q, Wood LV, Pinto LA. Immune Response Following Quadrivalent Human Papillomavirus Vaccination in Women After Hematopoietic Allogeneic Stem Cell Transplant: A Nonrandomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):696-705. doi: 10.1001/jamaoncol.2019.6722.

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