None listed
Conditions
Brief summary
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 focussed around targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls will commence in 2007. There is 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.
Interventions
Site One
Three doses will be given; the first will be given at 6-12mths post transplant for bone marrow transplant patients and pre-transplant for liver transplant patients. Patients with Inflammatory bowel disease will receive it at enrolment. The second vaccination will be given in 2 months post the first vaccination. The third dose will be 4 months post the second visit (6 months from the first vaccine).
Site Two
Three doses will be given, the first will be given at enrolment for patients
Site One Three doses will be given; the first will be given at 6-12mths post transplant for bone marrow transplant patients and pre-transplant for liver transplant patients. Patients with Inflammatory bowel disease will receive it at enrolment. The second vaccination will be given in 2 months post the first vaccination. The third dose will be 4 months post the second visit (6 months from the first vaccine). Site Two Three doses will be given, the first will be given at enrolment for patients with rheumatic disease such as juvenile idiopathic arthritis (JIA) and systemic lupus erythematosus (SLE). The second vaccination will be given in 2 months post the first vaccination. The third dose will be 4 months post the second visit (6 months from the first vaccine). At both sites The vaccines will be given in the non-dominant arm by a trained and experienced paediatric immunisation nurse Dose: Three 0.5 mL doses of Gardasil (registered product)
Sponsors
The Children's Hospital at Westmead
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Site One Must be either a Bone Marrow, Renal or Liver transplant recipient with no medical contraindication or a child with inflammatory bowel disease who has been on long-term immunosuppressive medication Cannot have previously received immunisation with HPV Vaccine. Must have a platelet count of >50 Cannot have had immunoglobulin therapy within 3 months Cannot have a yeast allergy or any other known allergies to one of the vaccine component Site Two Must have a diagnosis of Rheumatic disease" (such as Systemic Lupus Erythematosus or Juvenile Idiopathic Arthritis). Cannot have previously received immunisation with HPV Vaccine. Must have a platelet count of >50 Cannot have had immunoglobulin therapy within 3 months Cannot have a yeast allergy or any other known allergies to one of the vaccine component Cannot have had a flare of disease activity within three months prior to first dose of vaccine
Exclusion criteria
- A platelet count of <50 - Immunoglobulin therapy within 3 months. -Yeast allergy - Any other known allergies to one of the vaccine component
Outcome results
None listed