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Trial registered on ANZCTR


Registration number
ACTRN12609000571279
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
13/07/2009
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Human Papilloma Virus (HPV) Vaccination in Special Risk Groups
Scientific title
Prospective non controlled study of immunogenicity of Human Papilloma Virus (HPV) Vaccine in groups at special risk of poor vaccine result
Secondary ID [1] 273288 0
HPV special risk
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Special Risk Groups
1. Paediatric Rheumatalogical Disease
2. Inflammatory Bowel Disease
3. Acute Lymphoblastic Leukaemia
4. Solid Organ Transplant Recipients (kidney and liver)
5. Chronic Renal Disease
6. Bone Marrow Transsplant
The response to the HPV vaccine will be studied within these 6 special risk groups.
237155 0
Condition category
Condition code
Inflammatory and Immune System 237481 237481 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 236869 0
Prevention
Comparator / control treatment
Historical samples from original Merck immunogenicity study
Treatment given in original trial, 3 doses 4vHPV at 0, 2 & 6 months
(Reference:EA Joura, SK Kjaer, CM Wheeler, K Sigurdsson, O-E Iversen, M Hernandez-Avila, G Perez, DR Brown, LA Koutsky, EH Tay, et al: HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine 2008, 26:6844-6851.)
Control group
Historical

Outcomes
Primary outcome [1] 238287 0
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.
Timepoint [1] 238287 0
One month post third HPV vaccination
Secondary outcome [1] 244661 0
Describe the safety of the HPV vaccine in the six study groups using self reports and liason with treating sub specialist team.
Timepoint [1] 244661 0
One month post third HPV vaccination

Eligibility
Key inclusion criteria
Females aged 12-26 years
Have been diagnosed by a specialist with one of the six chronic medical conditions described.
Special Risk Groups
1. Paediatric Rheumatalogical Disease
2. Inflammatory Bowel Disease
3. Acute Lymphoblastic Leukaemia
4. Solid Organ Transplant Recipients (kidney and liver)
5. Chronic Renal Disease
6. Bone Marrow Transsplant
Minimum age
12 Years
Maximum age
26 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous immunisation with HPV vaccine
Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible Patients will be identified via the treating specialist physicians or clinics at the Royal Childrens Hospital
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237259 0
Charities/Societies/Foundations
Name [1] 237259 0
Shepherd Foundation
Address [1] 237259 0
Suite 33, Cabrini Medical Centre
Malvern vic 3144
Country [1] 237259 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council & Clinical Centre of Research Excellence(NHMRC CCRE) in Childhood and Adolescent Immunisation
Address
Department of General Medicine 5th floor, AP1 Building , Murdoch Childrens Research Institute
Royal Childrens Hospital Flemington Road Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 236745 0
Hospital
Name [1] 236745 0
Royal Childrens Hospital
Address [1] 236745 0
Department of General Medicine 5th floor, AP1 Building , Murdoch Childrens Research Institute
Royal Childrens Hospital Flemington Road Parkville Vic 3052
Country [1] 236745 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239361 0
The Royal Children's Hospital Ethics in Human Research Committee
Ethics committee address [1] 239361 0
Ethics and Research Department
Royal Children's Hospital
Flemington Road Parkville Vic 3052
Ethics committee country [1] 239361 0
Australia
Date submitted for ethics approval [1] 239361 0
Approval date [1] 239361 0
05/09/2007
Ethics approval number [1] 239361 0

Summary
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 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.
Trial website
Trial related presentations / publications
J Rheumatol. 2013 Sep;40(9):1626-7
Public notes

Contacts
Principal investigator
Name 29844 0
Dr Jim Buttery
Address 29844 0
SAEFVIC, MCRI. Royal Children's Hospital, Royal Pde Parkville, VIc. 3052
Country 29844 0
Australia
Phone 29844 0
+61 3 9345 4772
Fax 29844 0
Email 29844 0
jim.buttery@mcri.edu.au
Contact person for public queries
Name 13091 0
Dr Dr Jim Buttery
Address 13091 0
SAEFVIC, MCRI. Royal Children's Hospital, Royal Pde Parkville, VIc. 3052
Country 13091 0
Australia
Phone 13091 0
+61 3 9345 4772
Fax 13091 0
+61 3 9345 4163
Email 13091 0
jim.buttery@mcri.edu.au
Contact person for scientific queries
Name 4019 0
Dr Dr Jim Buttery
Address 4019 0
SAEFVIC, MCRI. Royal Children's Hospital, Royal Pde Parkville, VIc. 3052
Country 4019 0
Australia
Phone 4019 0
+61 3 9345 4772
Fax 4019 0
+61 3 9345 4163
Email 4019 0
jim.buttery@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary