View Clinical Trial (Medical Research Study)
A Phase I Trial of Safety and Immunogenicity of Gardasil(Registered Trademark) Vaccination Post Stem Cell Transplantation in Patients With and Without Immunosuppression
| City: |
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Bethesda |
| State: |
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Maryland |
| 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 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 .
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| 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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| NCT ID: |
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NCT01092195 |
| Primary Contact: |
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Principal Investigator
Pamela Stratton, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pamela Stratton, M.D.
Phone: (301) 496-5800
Email: strattop@exchange.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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