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

Cervical Cancer Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964210
• Other study ID #: RCH CA27091
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2009
• Last updated: April 14, 2011
• Start date: March 2008
• Est. completion date: April 2011

Study information

• Verified date: August 2009
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 26 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Childrens Hospital	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Brockhoff Foundation Australia, Shepherd Foundation Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes