Skip to main content
OpenTrials
Completed

NCT Number: NCT00964210

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Arthritis Arthritis, Juvenile Autoimmune Diseases Chronic Disease Connective Tissue Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Kidney Diseases Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Renal Insufficiency Renal Insufficiency, Chronic Rheumatic Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

12 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royal Childrens Hospital

Melbourne, Victoria, 3152, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Licensed quadrivalent HPV vaccine, Gardasil

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Brockhoff Foundation Australia
  • Shepherd Foundation Australia

Registry information

Official study title

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

Acronym: HPV

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 24, 2009
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.