Protocol Details
A Phase I Trial of Safety and Immunogenicity of Gardasil Vaccination Post Stem Cell Transplantation in Patients with and without Immunosuppression
This study is NOT currently recruiting participants.
Summary
Number |
10-H-0083 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 18 Years
Max Age: 50 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children;
Male;
Pregnant Women;
Fetuses |
Keywords |
Women's Health;
Genital Precancer;
Stem Cell Donor;
Cervical Cytology;
Healthy Volunteers |
Recruitment Keyword(s) |
Stem Cell Transplant;
Healthy Volunteer;
HV |
Condition(s) |
Gardasil Vaccine;
Stem Cell Transplant;
Immunogenicity |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Biological/Vaccine: Gardasil
|
Supporting Site |
National Heart, Lung, and Blood Institute |
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.
Eligibility
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 50 years
EXCLUSION CRITERIA:
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
Citations:
Munoz N, Bosch FX, de Sanjos(SqrRoot)(Copyright) S, Herrero R, Castellsagu(SqrRoot)(Copyright) 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.
Koutsky LA, Galloway DA, Holmes KK. Epidemiology of genital human papillomavirus infection. Epidemiol Rev. 1988;10:122-63.
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.
Contacts:
Clinical Trials Number:
NCT01092195