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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02263703
Registration number
NCT02263703
Ethics application status
Date submitted
3/10/2014
Date registered
13/10/2014
Date last updated
8/05/2024
Titles & IDs
Public title
Immunogenicity of HPV Vaccine in Immunosuppressed Children
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Scientific title
Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine
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Secondary ID [1]
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2007/028
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autoimmune Disease
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0
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Juvenile Idiopathic Arthritis
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Inflammatory Bowel Disease
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Evidence of Liver Transplantation
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Kidney Transplant Infection
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Bone Marrow Transplant Infection
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0
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Infection
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0
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0
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Sexually transmitted infections
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Musculoskeletal
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Quadrivalent HPV vaccine
Experimental: HPV vaccine - Quadrivalent HPV vaccine
Other interventions: Quadrivalent HPV vaccine
Three 0.5 mL doses will be given at time 0, 2 months after the 1st dose and then 6 months after the initial dose. For kidney transplant recipients the first dose will be at least 6 months post-transplant.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Immunogenicity
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Assessment method [1]
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Indicator:
Geometric mean four fold rises (with 95% confidence intervals) of the vaccine serotype specific IgG antibody in all participants.
Proportion of subjects achieving a 4 fold rise in antibody titre for each serotype. Serum antibody levels will be measured using a Luminex immunoassay.
Analysis: For each individual, the change in log-22FA levels for each serotype pre-post vaccination will be calculated. The average change will then be compared over time for each group and also between healthy and immunosuppressed groups using t-tests. Geometric mean titres of antibody for each serotype will be measured and compared at each follow up interval.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Duration of immunity
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Assessment method [1]
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Interpretation of Results: Persistance of immunity will be measured over 5 years, as well as the comparison of immunogenicity by immune status.
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Timepoint [1]
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5 years
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Eligibility
Key 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.
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Minimum age
5
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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School of Public Health and Community Medicine - Sydney
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Recruitment postcode(s) [1]
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2052 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Sydney Children's Hospitals Network
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Address [1]
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0
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Country [1]
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0
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Other collaborator category [2]
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Other
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Name [2]
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Women's and Children's Hospital, Australia
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Address [2]
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0
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Country [2]
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Ethics approval
Ethics application status
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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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02263703
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Raina MacIntyre
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Address
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The University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02263703
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