PRD (Paediatric Rheumatological Disease)NCT01896986
HPV Vaccination in Special Risk Groups: 5 Year Follow-up
An observational study of PRD (Paediatric Rheumatological Disease) and IBD (Inflammatory Bowel Disease), run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology. Read more about this study
- Who is it for?
- Ages 12 to 26 years, women only
- Conditions the study is for
- PRD (Paediatric Rheumatological Disease), IBD (Inflammatory Bowel Disease)
- How many people
- 37 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2012to Mar 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: In 2007 we began a clinical audit of the 'special risk patients' within two subgroups (PRD\&IBD). From April 2007- March 2010 there were 64 special risk female participants including 38 PRD patients of which 28 had juvenile idiopathic arthritis (JIA). The other subgroups included: 14 IBD; 10 paediatric cancer; 1 SOTR (solid organ transplant recipient) and 1 CRD (Chronic Renal Disease). The median age at the first dose of 4vHPV vaccine administration was 14.7 years [range 11.8 to 24.7]. The overall results were good with all participants showing at least some level of antibody protection against HPV. Long-term follow-up will help determine the requirement for booster vaccine doses, including those patients treated with combination immunosuppressive therapies.
Who may be able to join
- Females who participated in the initial HPV vaccine immunogenicity study in 2007.
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HPV Immunisation Protecting Special Risk Group Patients From Cervical Cancer: 5 Year Follow-up Post-vaccination
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology. The serological response to the vaccine was measured 1 month post the third and final dose (n=70) finding a robust response overall.
The aim of this follow-on study is to provide data on the long-term protection offered by the HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the impact on cervical cytology abnormalities in these special risk groups is important.
The study results will help inform national immunisation program recommendations re- booster HPV vaccine doses.
Read the detailed description
This study is an open interventional study based at two paediatric tertiary centres in Melbourne, Australia. It is specifically looking at the long term immunogenic response to the 4 valent HPV vaccine (4vHPV) Gardasil in paediatric rheumatology disease (PRD) and Irritable bowel disease (IBD) in participants who complete the primary HPV immunological study.
The study participant's response to the vaccine will be compared to Merck historical age-matched controls as there is currently no serological correlate of protection for the HPV vaccine.
The participants have already received the vaccine as part of the Australian federally funded catch up program which will run until mid-2009. All participants are part of 'Special risk groups'; which as defined by the Australian Immunisation Handbook, as patients who may have:
- special vaccination needs (e.g. children/ adolescents with a chronic medical condition) ; or
- a suboptimal response to vaccination (e.g. due to impaired immunity); or
- an increased risk of adverse events following immunization (AEFI)
The 'special risk groups' currently included in the study are:
- PRD- Paediatric Rheumatological Diseases
- IBD- Inflammatory Bowel Disease
Number of participants
Total number of patients to be recruited is N = 60
The aim is to recruit n= 45 patients from PRD and n=15 patients from IBD.
Immunisation history will be correlated with the HPV register.
Main outcome measures
The primary immunogenicity endpoint will be serum antibody by month 60 (i.e. 5 years post 3rd and final dose of 4vHPV vaccine).
Antibody titres are determined by using type-specific competitive neutralising antibody to epitopes on virus like particles (VLP). This will be for each of the 4 serotypes in the vaccine [6,11,16,18], with geometric mean titre (GMT) will be measured in mMU; and will be compared with GMT from historical age-matched controls.
Frequency of assessment
There will only be one immunogenicity assessment point, 60 month post the third and final dose of 4vHPV vaccine.
Primary Objective:
- Long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne. Antibody titres are determined by using type specific neutralizing antibody.The geometric mean titre (GMT) will be measured in mMU; with a type specific cutoff for the assay (> 20mMU/ml for the HPV6; > 16mMU/ml for the HPV11; > 20mMU/ml for the HPV16 and >24mMU/ml for the HPV18). [13,15] HPV serology will be performed using competitive Luminex based immunoassays.
Secondary Objective:
- The safety of the HPV vaccine in the 2 (PRD, IBD) study groups, measured by the number of adverse events reported by study participants.
- Keywords
- Special risk patients, Immunosuppressive biologic treatments, PRD (Paediatric Rheumatological Disease), IBD (Inflammatory Bowel Disease)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRD patrients | Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy | |
| IBD patients | Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity to HPV Vaccine Gardasil
To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PRD (Paediatric Rheumatological Disease)Studies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Monash Medical Centre
- Responsible party
- Principal investigator, Nigel Crawford, Murdoch Childrens Research Institute
- Investigators
- Nigel Crawford, PhDMPHMBBS, Principal investigator, Royal Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896986
- Sponsor's protocol ID
- HPV girls 5year followup
- Status last verified
- Mar 2017
- First submitted
- 25 Jun 2013
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Immunisation Protecting Special Risk Group Patients From Cervical Cancer: 5 Year Follow-up Post-vaccination
- ClinicalTrials.gov ID
- NCT01896986
- Acronym / sponsor ID
- HPV girls 5year followup
- Keywords
- Special risk patients, Immunosuppressive biologic treatments, PRD (Paediatric Rheumatological Disease), IBD (Inflammatory Bowel Disease)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment problems
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Monash Medical Centre
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 15 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2007-2009 the investigators conducted a study to determine the immunogenicity response to HPV vaccine in special risk patients known to be at increased risk of abnormal cervical cytology. The serological response to the vaccine was measured 1 month post the third and final dose (n=70) finding a robust response overall.
The aim of this follow-on study is to provide data on the long-term protection offered by the HPV vaccination. The persistence of antibody 5 years post immunisation is unknown and the impact on cervical cytology abnormalities in these special risk groups is important.
The study results will help inform national immunisation program recommendations re- booster HPV vaccine doses.
Detailed description
This study is an open interventional study based at two paediatric tertiary centres in Melbourne, Australia. It is specifically looking at the long term immunogenic response to the 4 valent HPV vaccine (4vHPV) Gardasil in paediatric rheumatology disease (PRD) and Irritable bowel disease (IBD) in participants who complete the primary HPV immunological study.
The study participant's response to the vaccine will be compared to Merck historical age-matched controls as there is currently no serological correlate of protection for the HPV vaccine.
The participants have already received the vaccine as part of the Australian federally funded catch up program which will run until mid-2009. All participants are part of 'Special risk groups'; which as defined by the Australian Immunisation Handbook, as patients who may have:
- special vaccination needs (e.g. children/ adolescents with a chronic medical condition) ; or
- a suboptimal response to vaccination (e.g. due to impaired immunity); or
- an increased risk of adverse events following immunization (AEFI)
The 'special risk groups' currently included in the study are:
- PRD- Paediatric Rheumatological Diseases
- IBD- Inflammatory Bowel Disease
Number of participants
Total number of patients to be recruited is N = 60
The aim is to recruit n= 45 patients from PRD and n=15 patients from IBD.
Immunisation history will be correlated with the HPV register.
Main outcome measures
The primary immunogenicity endpoint will be serum antibody by month 60 (i.e. 5 years post 3rd and final dose of 4vHPV vaccine).
Antibody titres are determined by using type-specific competitive neutralising antibody to epitopes on virus like particles (VLP). This will be for each of the 4 serotypes in the vaccine [6,11,16,18], with geometric mean titre (GMT) will be measured in mMU; and will be compared with GMT from historical age-matched controls.
Frequency of assessment
There will only be one immunogenicity assessment point, 60 month post the third and final dose of 4vHPV vaccine.
Primary Objective:
- Long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne. Antibody titres are determined by using type specific neutralizing antibody.The geometric mean titre (GMT) will be measured in mMU; with a type specific cutoff for the assay (> 20mMU/ml for the HPV6; > 16mMU/ml for the HPV11; > 20mMU/ml for the HPV16 and >24mMU/ml for the HPV18). [13,15] HPV serology will be performed using competitive Luminex based immunoassays.
Secondary Objective:
- The safety of the HPV vaccine in the 2 (PRD, IBD) study groups, measured by the number of adverse events reported by study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRD patrients | – | –Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy |
| IBD patients | – | –Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy |
Who may qualify
- Ages
- 12 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- In 2007 we began a clinical audit of the 'special risk patients' within two subgroups (PRD\&IBD). From April 2007- March 2010 there were 64 special risk female participants including 38 PRD patients of which 28 had juvenile idiopathic arthritis (JIA). The other subgroups included: 14 IBD; 10 paediatric cancer; 1 SOTR (solid organ transplant recipient) and 1 CRD (Chronic Renal Disease). The median age at the first dose of 4vHPV vaccine administration was 14.7 years [range 11.8 to 24.7]. The overall results were good with all participants showing at least some level of antibody protection against HPV. Long-term follow-up will help determine the requirement for booster vaccine doses, including those patients treated with combination immunosuppressive therapies.
Key inclusion criteria (1 listed)
- Females who participated in the initial HPV vaccine immunogenicity study in 2007.
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunogenicity to HPV Vaccine Gardasil
Time frame: 12 months
To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Crawford, PhDMPHMBBS principal investigator
Royal Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PRD (Paediatric Rheumatological Disease) and IBD (Inflammatory Bowel Disease), run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity to HPV Vaccine Gardasil (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.