- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00964210
Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination (HPV)
Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3152
- Royal Childrens Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Females aged 12-26 years
Have been diagnosed by a specialist with one of the six chronic medical conditions described:
- Paediatric Rheumatological Disease
- Inflammatory Bowel Disease
- Acute Lymphoblastic Leukaemia
- Solid Organ Transplant Recipients (kidney and liver)
- Chronic Renal Disease
- Bone Marrow Transplant
Exclusion Criteria:
- Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
One Month post HPV vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
One month post third HPV vaccination
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jim Buttery, NHMRC CCRE in Childhood and Adolescent Immunisation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCH CA27091
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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