NCT00964210

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

Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: Female
• Age: 12 Years – 26 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-12-01
• Completion: 2011-04-01
• First posted: 2009-08-24
• Last updated: 2011-04-15

Locations

1 site across 1 country: Australia