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

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Licensed quadrivalent HPV vaccine, Gardasil

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant

Eligibility Criteria

12 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Royal Childrens Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.

Full Information

NCT ID

NCT00964210

First Posted

August 21, 2009

Last Updated

April 14, 2011

Sponsor

Murdoch Childrens Research Institute

Collaborators

Brockhoff Foundation Australia, Shepherd Foundation Australia

1. Study Identification

Unique Protocol Identification Number

NCT00964210

Brief Title

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

Acronym

HPV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Murdoch Childrens Research Institute

Collaborators

Brockhoff Foundation Australia, Shepherd Foundation Australia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Licensed quadrivalent HPV vaccine, Gardasil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

One Month post HPV vaccination

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Females aged 12-26 years Have been diagnosed by a specialist with one of the six chronic medical conditions described: Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplant Exclusion Criteria: Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jim Buttery

Organizational Affiliation

NHMRC CCRE in Childhood and Adolescent Immunisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Childrens Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3152

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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