| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Gardasil Vaccine - Stem Cell Transplant - Immunogenicity - Quadrivalent HPC Vaccine - Healthy Volunteers |
| Purpose: |
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Background:
- Gardasil(Registered Trademark), 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 45 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.
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| Study summary: |
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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 (Registered Trademark))
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 (Registered Trademark) 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 post-transplant 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). Gardasil(Registered
Trademark) will be administered using the FDA approved regimen of 3 separate 0.5ml
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. |
| Criteria: |
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- INCLUSION CRITERIA:
Female stem cell transplant recipient at least 90 days post stem cell transplant
OR
Female stem cell transplant recipient at least 90 days post HSCT and on immunosuppression
OR
The matched female stem cell transplant donor for an included stem cell transplant
recipient
OR
Healthy female subject
Age greater than or equal to 18 years and less than or equal to 45 years
EXCLUSION CRITERIA:
Vaccine Recipient:
Obvious HPV condyloma or obvious severe dysplasia (greater than or equal to CIN II)
History of severe adverse reaction to any components (yeast, eggs, monosodium glutamate or
neomycin) of the quadrivalent HPV vaccine.
Untreated or persistent life-threatening infections not controlled by current treatment
Uncontrolled chronic GVHD i.e. highly active eGVHD requiring immediate intervention
Pregnant or breast feeding or unwilling to be abstinent or practice effective
contraception during the study period (note: patients who have been rendered infertile
with total body irradiation are eligible)
Enrollment in another vaccine clinical trial during the study period
Enrollment of healthy volunteer in a drug clinical trial during the study period
Inability to comprehend the investigational nature of the study and provide informed
consent
Prior Gardasil or other HPV vaccination
Persistent or recurrent malignancy |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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