CompletedPhase 3ACTRN12609000571279

Human Papilloma Virus (HPV) Vaccination in Special Risk Groups

Prospective non controlled study of immunogenicity of Human Papilloma Virus (HPV) Vaccine in groups at special risk of poor vaccine result


Sponsor

National Health and Medical Research Council & Clinical Centre of Research Excellence(NHMRC CCRE) in Childhood and Adolescent Immunisation

Enrollment

100 participants

Start Date

Mar 12, 2008

Study Type

Interventional

Conditions

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 Rheumatalogical 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.


Eligibility

Sex: FemalesMin Age: 12 YearssMax Age: 26 Yearss

Inclusion Criteria9

  • Females aged 12-26 years
  • Have been diagnosed by a specialist with one of the six chronic medical conditions described.
  • Special Risk Groups
  • Paediatric Rheumatalogical Disease
  • Inflammatory Bowel Disease
  • Acute Lymphoblastic Leukaemia
  • Solid Organ Transplant Recipients (kidney and liver)
  • Chronic Renal Disease
  • Bone Marrow Transsplant

Exclusion Criteria2

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

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Interventions

Licensed quadrivalent HPV vaccine. 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.

Licensed quadrivalent HPV vaccine. 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.


Locations(1)

Australia

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ACTRN12609000571279