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Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination

This study has been completed.
Sponsor:
Collaborators:
Brockhoff Foundation Australia
Shepherd Foundation Australia
Information provided by:
Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier:
NCT00964210
First received: August 21, 2009
Last updated: April 14, 2011
Last verified: August 2009
History of Changes
  Purpose

A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 & 18, cervical cancer and HPV types 6 & 11, anogenital warts.

The six special risk groups include:

Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.

This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.


Condition Intervention Phase
Cervical Cancer
 Drug: Licensed quadrivalent HPV vaccine, Gardasil
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Murdoch Childrens Research Institute:

Primary Outcome Measures:
  • Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity. [ Time Frame: One Month post HPV vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team. [ Time Frame: One month post third HPV vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Licensed quadrivalent HPV vaccine, Gardasil
    The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.
  Eligibility

Ages Eligible for Study:   12 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females aged 12-26 years

  • Have been diagnosed by a specialist with one of the six chronic medical conditions described:

    1. Paediatric Rheumatological Disease
    2. Inflammatory Bowel Disease
    3. Acute Lymphoblastic Leukaemia
    4. Solid Organ Transplant Recipients (kidney and liver)
    5. Chronic Renal Disease
    6. Bone Marrow Transplant

Exclusion Criteria:

  • Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964210

Locations
Australia, Victoria
Royal Childrens Hospital
Melbourne, Victoria, Australia, 3152
Sponsors and Collaborators
Murdoch Childrens Research Institute
Brockhoff Foundation Australia
Shepherd Foundation Australia
Investigators
Principal Investigator: Jim Buttery NHMRC CCRE in Childhood and Adolescent Immunisation
  More Information

No publications provided

Responsible Party: Doctor Jim Buttery, Royal Childrens hospital
ClinicalTrials.gov Identifier: NCT00964210     History of Changes
Other Study ID Numbers: RCH CA27091
Study First Received: August 21, 2009
Last Updated: April 14, 2011
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Murdoch Childrens Research Institute:
Juvenile Idiopathic Arthritis
Inflammatory Bowel Disease
Acute Lymphoblastic Leukemia
Chronic Renal Disease
Solid Organ Transplant

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Papilloma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013