Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00964210




Registration number
NCT00964210
Ethics application status
Date submitted
21/08/2009
Date registered
24/08/2009
Date last updated
15/04/2011

Titles & IDs
Public title
Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination
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] 0 0
RCH CA27091
Universal Trial Number (UTN)
Trial acronym
HPV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Licensed quadrivalent HPV vaccine, Gardasil

Treatment: Drugs: Licensed quadrivalent HPV vaccine, Gardasil
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] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

1. Paediatric Rheumatological Disease

2. Inflammatory Bowel Disease

3. Acute Lymphoblastic Leukaemia

4. Solid Organ Transplant Recipients (kidney and liver)

5. Chronic Renal Disease

6. Bone Marrow Transplant
Minimum age
12 Years
Maximum age
26 Years
Sex
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
N/A
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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Childrens Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3152 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Brockhoff Foundation Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Shepherd Foundation Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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 Rheumatological 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
https://clinicaltrials.gov/ct2/show/NCT00964210
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim Buttery
Address 0 0
NHMRC CCRE in Childhood and Adolescent Immunisation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00964210