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

NCT00964210 | Completed Phase 3 DMC

• 1 other identifier: RCH CA27091
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

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.

  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.

  One month post third HPV vaccination

Interventions

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.

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Brockhoff Foundation Australia: collaborator
• Shepherd Foundation Australia: collaborator

Study Sites (1)

Royal Childrens Hospital

Melbourne, Victoria, 3152, Australia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Arthritis, Juvenile; Inflammatory Bowel Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Renal Insufficiency, Chronic

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Jim Buttery

  NHMRC CCRE in Childhood and Adolescent Immunisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 24, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2009-08

Locations

AU (1)