Trial Information

A Phase I Trial of Safety and Immunogenicity of Gardasil(Registered Trademark) Vaccination Post Stem Cell Transplantation in Patients With and Without Immunosuppression

HPV associated genital dysplasia is a complication following hematopoetic allogeneic stem
cell transplantation (HSCT). In a recent study from this institution, one third of female
transplant recipients had HPV related genital tract dysplasia. The quadrivalent human
papillomavirus virus (HPV) (types 6,11, 16, 18) vaccine (Gardasil e) is now approved for use
in females aged 9-26 for the prevention of cervical cancer and more recently vulvar and
vaginal cancer. In this study, Gardasil e will be used in females age 18 years or older at
least 90 days post stem cell transplant with full donor chimerism in two study cohorts to
determine its safety and immunogenicity in this population, as a first step to reduce
posttransplant HPV-related co-morbidity, genital dysplasia and malignancy. The two study
cohorts will both be post transplant; one off of immunosuppression (n=24), and one on
immunosuppression (n=24). Gardasile will be administered using the FDA approved regimen of 3
separate O.Sml intramuscular injections at 0, 2, and 6 months. The primary objectives of
this study are to determine the safety and immunogenicity of Gardasil in female allogeneic
HSCT recipients. A cohort of healthy subjects will also be vaccinated (n=24) and will serve
as a control. Immunogenicity studies characterizing the CD4 and CD8 T- cell response, change
in antibody titer and cytokine response from baseline to months seven and twelve will be
compared in the three cohorts. Additionally, genital exams will be performed to monitor for
HPV. Secondary endpoints will characterize sexual function post transplant and
vulvar/vaginal graft versus host disease (GVHD). When available, healthy female stem cell
donors corresponding to enrolled vaccine recipients will be enrolled (n=10) as part of the
healthy cohort and vaccinated to determine whether there are differences in HPV vaccine
immunogenicity in a subset of donors and their respective allogeneic, HSCT female
recipients. As stem cell transplant becomes more applicable to the general population with
newer transplant techniques allowing for a larger donor pool and as survival improves,
problems associated with long term survivorship such as genital dysplasia, will become more
prevalent. Vaccine therapy to prevent or eradicate this disease is needed .