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

Murdoch Childrens Research Institute

Status and phase

Completed

Phase 3

Conditions

Cervical Cancer

Treatments

Drug: Licensed quadrivalent HPV vaccine, Gardasil

Study type

Interventional

Funder types

Other

Identifiers

NCT00964210

RCH CA27091

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

Female

Ages

12 to 26 years old

Volunteers

No 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