Immunogenicity of HPV Vaccine in Immunosuppressed Children
Immunogenicity of HPV Vaccine in Immunosuppressed Children
Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause
 of several other cancers and conditions. There are now effective vaccines against the main
 oncogenic HPV types, HPV16 and 18.

 Most research and discussion has focused on targeting the vaccine to young women and older
 adolescents. Based on this, a national free HPV vaccination program for adolescent girls
 commenced in 2007, in Australia. However, at the time of commencement, there had been no
 research on the use of this vaccine in immunosuppressed. Therefore, information on the
 immunogenicity, safety and duration of efficacy of HPV vaccine when administered to
 immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent
 HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity,
 followed for 5 years for duration of immunity.
To determine the immunogenicity, safety and persistence of immunity following human
 papillomavirus (HPV) vaccination in three groups of immunosuppressed children: recipients of
 allogenic bone marrow transplant, recipients of renal and liver transplants, and patients
 with juvenile chronic arthritis, inflammatory bowel disease and other autoimmune conditions
 who are on longterm immunosuppressive therapy.

 Significance: Immunosuppressed populations are diverse in terms of degree, type and duration
 of immunosuppression. The study compares several groups in order to address the heterogeneity
 of immunosuppression and how this affects vaccine response. BMT patients have extreme, severe
 immunosuppression in the short term, but recover immune function with time. In contrast,
 solid organ transplant recipients have ongoing, chronic immunosuppression. Although
 successful cessation of immunosuppressives in liver transplant patients has been reported,
 most patients require ongoing treatment. The inflammatory bowel disease group of patients
 represents a non-transplant group who require ongoing, often low level immunosuppression,
 often with corticosteroids. Our study will compare these three groups, followed up for five
 years for duration of immunity. Time of vaccines, time of serological measures of immune
 response are as follows.

 Serum collections:

 0 - Baseline (before HPV vaccine dose 1); 2 months - At the time of receipt of HPV vaccine
 dose 2 (to measure response to dose 1); 6 months - At the time of receipt of HPV vaccine dose
 3 (to measure response to dose 2); 7 months - 1 month after HPV vaccine dose 3; 12 months -
 after HPV vaccine dose 1; 2 years after HPV vaccine dose 1; 3 years after HPV vaccine dose 1;
 4 years after HPV vaccine dose 1; 5 years after HPV vaccine dose 1.
Inclusion Criteria:

 - Immunosuppressed patients with following diseases; Bone marrow transplant recipients,
 liver transplant patients, renal transplant, Children with inflammatory bowel disease,
 juvenile Idiopathic arthritis and autoimmune conditions.

 Exclusion Criteria:

 -  A platelet count of <50

 -  Immunoglobulin therapy within 3 months.

 -  Yeast allergy

 -  Any other known allergies to one of the vaccine component