Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination (HPV)
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|ClinicalTrials.gov Identifier: NCT00964210|
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : April 15, 2011
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 or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Licensed quadrivalent HPV vaccine, Gardasil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2011|
- 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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964210
|Royal Childrens Hospital|
|Melbourne, Victoria, Australia, 3152|
|Principal Investigator:||Jim Buttery||NHMRC CCRE in Childhood and Adolescent Immunisation|