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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Licensed quadrivalent HPV vaccine, Gardasil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant