Gardasil Vaccination in Post Stem Cell Transplant Patients

NCT01092195 | Completed Phase 1 Results

• 2 other identifiers: 10008310-H-0083
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gardasil Vaccine; Stem Cell Transplant; Immunogenicity

Keywords

Women's Health; Genital Precancer; Stem Cell Donor; Cervical Cytology; Healthy Volunteers; Stem Cell Transplant; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Developed Antibody Response to the Vaccine.

  The percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.

  12 months

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Female subjects post stem cell transplant on no systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.

Biological: Gardasil

Cohort 2

ACTIVE COMPARATOR

Female subjects post stem cell transplant with chronic GVHD requiring systemic immunosuppression. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.

Biological: Gardasil

Cohort 3

ACTIVE COMPARATOR

Healthy normal female volunteers. Gardasil® will be administered using the FDA approved regimen of 3 separate 0.5ml intramuscular injections at 0, 2, and 6 months.

Biological: Gardasil

Interventions

Gardasil BIOLOGICAL

3 separate 0.5 ml intramuscular

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female stem cell transplant recipient at least 90 days post stem cell transplant
• Female stem cell transplant recipient at least 90 days post HSCT and on immunosuppression
• The matched female stem cell transplant donor for an included stem cell transplant recipient
• Healthy female subject
• Age greater than or equal to 18 years and less than or equal to 50 years

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague 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. doi: 10.1056/NEJMoa021641.

  PMID: 12571259 BACKGROUND

• Koutsky LA, Galloway DA, Holmes KK. Epidemiology of genital human papillomavirus infection. Epidemiol Rev. 1988;10:122-63. doi: 10.1093/oxfordjournals.epirev.a036020.

  PMID: 2852116 BACKGROUND

• 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. doi: 10.1097/01.olq.0000145851.76025.ad.

  PMID: 15608590 BACKGROUND

• Stratton P, Battiwalla M, Tian X, Abdelazim S, Baird K, Barrett AJ, Cantilena CR, Childs RW, DeJesus J, Fitzhugh C, Fowler D, Gea-Banacloche J, Gress RE, Hickstein D, Hsieh M, Ito S, Kemp TJ, Khachikyan I, Merideth MA, Pavletic SZ, Quint W, Schiffman M, Scrivani C, Shanis D, Shenoy AG, Struijk L, Tisdale JF, Wagner S, Williams KM, Yu Q, Wood LV, Pinto LA. Immune Response Following Quadrivalent Human Papillomavirus Vaccination in Women After Hematopoietic Allogeneic Stem Cell Transplant: A Nonrandomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):696-705. doi: 10.1001/jamaoncol.2019.6722.

  PMID: 32105293 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Pamela Stratton MD
• Organization: National Institutes of Health

strattop@mail.nih.gov

301-435-4068

Study Officials

• Richard W Childs, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 24, 2010
• Study Start: June 2, 2010
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: August 6, 2019
• Results First Posted: July 1, 2019

Record last verified: 2018-07

Locations

US (1)