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Trial registered on ANZCTR


Registration number
ACTRN12608000260325
Ethics application status
Approved
Date submitted
15/05/2008
Date registered
22/05/2008
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immunogenicity and duration of immunity in immunosuppressed children vaccinated with Human papillomavirus vaccine
Scientific title
Immunogenicity of Human papillomavirus vaccine in immunosuppressed children
Secondary ID [1] 283571 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human papillomavirus (HPV) 3145 0
Condition category
Condition code
Cancer 3304 3304 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 2882 0
Prevention
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4194 0
Reactogenicity
Measuring Instruments: The subject or carer will be given diary card, a digital thermometer, and ruler. The nurse will provide instructions on how to use the thermometer and how to record any local or systemic reactions on the diary.
Study nurses will complete an adverse event questionnaire by telephone on day 1 and day 7. Any medical consultations, medications taken and hospitalisations will be ascertained at 3 months, 6 months (follow up visit), 9 months and 12 months (follow up visit)
Timepoint [1] 4194 0
6- monthly intervals for the first 2 years and every 12 months for the following 3 years
Primary outcome [2] 4195 0
Duration of immunity
Measuring Instruments: Serological immunity to HPV serotypes in the vaccine at baseline and according to the listed schedule.
Timepoint [2] 4195 0
6- monthly intervals for the first 2 years and every 12 months for the following 3 years
Primary outcome [3] 4196 0
Immunogenicity
Measuring Instruments: Serological immunity to HPV serotypes in the vaccine at baseline and according to the listed schedule. Serum anti-HPV 16/18 antibody levels will be measured using a Luminex immunoassay. Antibody titres will be determined in a competitive format, where known, type-specific, phycoerythrin-labeled, neutralizing antibodies compete with patient serum antibodies for binding to conformationally sensitive, neutralizing epitopes on the virus like particles (VLPs). The monoclonal antibodies to be used in the HPV cLIA include H16.V5 for HPV 16 and H18.J4 for HPV 18.
Timepoint [3] 4196 0
6- monthly intervals for the first 2 years and every 12 months for the following 3 years
Secondary outcome [1] 7088 0
Immunogenicity to other vaccinations administered- pneumococcal, hepatitis B, diphtheria, tetanus, pertussis, influenza, polio and meningococcal. There are limited data on response to these vaccines in immunosuppressed populations.
Timepoint [1] 7088 0
Up to 5 years

Eligibility
Key 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
Minimum age
5 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A platelet count of <50
- Immunoglobulin therapy within 3 months.
-Yeast allergy
- Any other known allergies to one of the vaccine component

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
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)
NSW,SA

Funding & Sponsors
Funding source category [1] 3381 0
Commercial sector/Industry
Name [1] 3381 0
CSL Biotherapies
Address [1] 3381 0
45 Poplar Road
Parkville,
Victoria 3052
Australia
Country [1] 3381 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead, 2145
Country
Australia
Secondary sponsor category [1] 3023 0
Other Collaborative groups
Name [1] 3023 0
Center for Infectious Diseases and Microbiology
Address [1] 3023 0
Level 3, ICPMR Building
Westmead Hospital, Darcy Road, NSW 2145
Country [1] 3023 0
Australia
Secondary sponsor category [2] 3402 0
Hospital
Name [2] 3402 0
Women's & Children's Hospital
Address [2] 3402 0
72 King William Road,
North Adelaide, SA, 5006
Country [2] 3402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5406 0
The Children's Hospital at Westmead, Ethics Committee
Ethics committee address [1] 5406 0
The Children's Hospital at Westmead
Corner Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead, NSW, 2145
Ethics committee country [1] 5406 0
Australia
Date submitted for ethics approval [1] 5406 0
21/02/2007
Approval date [1] 5406 0
22/04/2007
Ethics approval number [1] 5406 0

Summary
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.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 28586 0
Prof Raina MacIntyre
Address 28586 0
Biosecurity Research Program, Level 6, Wallace Wurth building, Kirby Institute
UNSW Sydney, NSW 2052
Country 28586 0
Australia
Phone 28586 0
+61 2 93850874
Fax 28586 0
+61 2 9385 0920
Email 28586 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 11743 0
Dr Aye Moa
Address 11743 0
Biosecurity Research Program, Level 6, Wallace Wurth building, Kirby Institute
UNSW Sydney, NSW 2052
Country 11743 0
Australia
Phone 11743 0
+61 2 9385 0938
Fax 11743 0
+61 2 9385 0920
Email 11743 0
a.moa@unsw.edu.au
Contact person for scientific queries
Name 2671 0
Prof Prof Raina MacIntyre
Address 2671 0
Level 3, Samuels Building,
The School of Public Health and Community Medicine, Faculty of Medicine,
The University of New South Wales
Country 2671 0
Australia
Phone 2671 0
+61 2 9385 0874
Fax 2671 0
+61 2 9385 0920
Email 2671 0
r.macintyre@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5820 0
MacIntyre CR, Shaw PJ, Mackie FE, Boros C, Marshall H, Seale H, et al. Long term follow up of persistence of immunity following quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2019;37(37):5630-6.
Available online 8 August 2019.
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary