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

April 14, 2011 updated by: Murdoch Childrens Research Institute

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

Completed

Conditions

Cervical Cancer

Intervention / Treatment

Drug: Licensed quadrivalent HPV vaccine, Gardasil

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia, 3152
    - Royal Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Collaborators

Brockhoff Foundation Australia

Shepherd Foundation Australia

Investigators

Principal Investigator: Jim Buttery, NHMRC CCRE in Childhood and Adolescent Immunisation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria