NIH Clinical Center Search the Studies: Study Number, Study Title

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 | Eligibility | Citations | Contacts

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
Max Age: 50

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.

--Back to Top--

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


--Back to Top--

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Richard W. Childs, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 3-5330
10 CENTER DR
BETHESDA MD 20814
(301) 451-7128
childsr@nhlbi.nih.gov

Pamela Stratton, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 7-4647
10 CENTER DR
BETHESDA MD 20892
(301) 435-4068
strattop@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01092195

--Back to Top--