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

Phase 3

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT00964210
• Lead Sponsor: Murdoch Childrens Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2009-08
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2010-12
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	One Month post HPV vaccination

Secondary Outcome Measures

Name	Time	Method
Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.	One month post third HPV vaccination

Trial Locations

Locations (1)

Royal Childrens Hospital; 🇦🇺 Melbourne, Victoria, Australia