Trial | NCT00964210  Report issue

Title

Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination
Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    240
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 Started
Mar 31
2008
Primary Completion
Dec 31
2010
Study Completion
Apr 30
2011
Last Update
Apr 15
2011
Estimate

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.

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
No Results Posted