Gardasil Vaccination in Post Stem Cell Transplant Patients

Completed · Phase 1

Conditions studied: Gardasil Vaccine, Stem Cell Transplant, Immunogenicity

In brief

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.

Key facts

Study ID

NCT01092195

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

64

Starts

2010-06-02

Expected to finish

2016-07-19

Last updated by the study team

2019-08-06

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Vaccine Recipient:
• Obvious HPV condyloma or obvious severe dysplasia (greater than or equal to CIN II) warranting treatment
• 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<TAB>
• Prior Gardasil or other HPV vaccination
• Persistent or recurrent malignancy

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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