Autoimmune DiseasePhase 3NCT02263703
Immunogenicity of HPV Vaccine in Immunosuppressed Children
A Phase 3 study testing Quadrivalent HPV vaccine in people with Autoimmune Disease and Juvenile Idiopathic Arthritis, run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autoimmune Disease, Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease
- What is being tested?
- Quadrivalent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- May 2007to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- A platelet count of <50
- Immunoglobulin therapy within 3 months.
- Yeast allergy
- Any other known allergies to one of the vaccine component
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Public Health and Community Medicine
Sydney, New South Wales, 2052
About this study
Official title: Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine
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.
Read the detailed description
To determine the immunogenicity, safety and persistence of immunity following human papillomavirus (HPV) vaccination in three groups of immunosuppressed children: recipients of allogenic bone marrow transplant, recipients of renal and liver transplants, and patients with juvenile chronic arthritis, inflammatory bowel disease and other autoimmune conditions who are on longterm immunosuppressive therapy.
Significance: Immunosuppressed populations are diverse in terms of degree, type and duration of immunosuppression. The study compares several groups in order to address the heterogeneity of immunosuppression and how this affects vaccine response. BMT patients have extreme, severe immunosuppression in the short term, but recover immune function with time. In contrast, solid organ transplant recipients have ongoing, chronic immunosuppression. Although successful cessation of immunosuppressives in liver transplant patients has been reported, most patients require ongoing treatment. The inflammatory bowel disease group of patients represents a non-transplant group who require ongoing, often low level immunosuppression, often with corticosteroids. Our study will compare these three groups, followed up for five years for duration of immunity. Time of vaccines, time of serological measures of immune response are as follows.
Serum collections:
0 - Baseline (before HPV vaccine dose 1); 2 months - At the time of receipt of HPV vaccine dose 2 (to measure response to dose 1); 6 months - At the time of receipt of HPV vaccine dose 3 (to measure response to dose 2); 7 months - 1 month after HPV vaccine dose 3; 12 months - after HPV vaccine dose 1; 2 years after HPV vaccine dose 1; 3 years after HPV vaccine dose 1; 4 years after HPV vaccine dose 1; 5 years after HPV vaccine dose 1.
- Conditions
- Autoimmune Disease, Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Evidence of Liver Transplantation, Kidney Transplant Infection, Bone Marrow Transplant Infection
- Being tested
- Quadrivalent HPV vaccine
- Keywords
- HPV vaccine, children, immunocompromised
- Medical subject headings
- Autoimmune Diseases, Arthritis, Juvenile, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent HPV vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccine | Experimental | Quadrivalent HPV vaccine Receives: Biological: Quadrivalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
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.
Measured: 2 years
Secondary outcomes (1)
Duration of immunity
Interpretation of Results: Persistance of immunity will be measured over 5 years, as well as the comparison of immunogenicity by immune status.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMay 2007
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Sydney Children's Hospitals Network, Women's and Children's Hospital, Australia
- Responsible party
- Principal investigator, Prof Raina MacIntyre, The University of New South Wales
- Investigators
- Raina MacIntyre, Principal investigator, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263703
- Sponsor's protocol ID
- 2007/028
- Status last verified
- May 2024
- First submitted
- 3 Oct 2014
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We would like to share publication(s) that may arise from the study when applicable.
Publications
MacIntyre CR, Shaw P, Mackie FE, Boros C, Marshall H, Barnes M, Seale H, Kennedy SE, Moa A, Hayen A, Chughtai AA, O'Loughlin EV, Stormon M. Immunogenicity and persistence of immunity of a quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2016 Aug 5;34(36):4343-50. doi: 10.1016/j.vaccine.2016.06.049. Epub 2016 Jul 9.
PubMed 27406936MacIntyre CR, Shaw PJ, Mackie FE, Boros C, Marshall H, Seale H, Kennedy SE, Moa A, Chughtai AA, Trent M, O'Loughlin EV, Stormon M. Long term follow up of persistence of immunity following quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2019 Sep 3;37(37):5630-5636. doi: 10.1016/j.vaccine.2019.07.072. Epub 2019 Aug 8.
PubMed 31402238
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Duration of Immunity in Immunosuppressed Children Vaccinated With Quadrivalent HPV Vaccine
- ClinicalTrials.gov ID
- NCT02263703
- Acronym / sponsor ID
- 2007/028
- Conditions
- Autoimmune Disease, Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Evidence of Liver Transplantation, Kidney Transplant Infection, Bone Marrow Transplant Infection
- Keywords
- HPV vaccine, children, immunocompromised
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Sydney Children's Hospitals Network, Women's and Children's Hospital, Australia
- Study start
- May 2007 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To determine the immunogenicity, safety and persistence of immunity following human papillomavirus (HPV) vaccination in three groups of immunosuppressed children: recipients of allogenic bone marrow transplant, recipients of renal and liver transplants, and patients with juvenile chronic arthritis, inflammatory bowel disease and other autoimmune conditions who are on longterm immunosuppressive therapy.
Significance: Immunosuppressed populations are diverse in terms of degree, type and duration of immunosuppression. The study compares several groups in order to address the heterogeneity of immunosuppression and how this affects vaccine response. BMT patients have extreme, severe immunosuppression in the short term, but recover immune function with time. In contrast, solid organ transplant recipients have ongoing, chronic immunosuppression. Although successful cessation of immunosuppressives in liver transplant patients has been reported, most patients require ongoing treatment. The inflammatory bowel disease group of patients represents a non-transplant group who require ongoing, often low level immunosuppression, often with corticosteroids. Our study will compare these three groups, followed up for five years for duration of immunity. Time of vaccines, time of serological measures of immune response are as follows.
Serum collections:
0 - Baseline (before HPV vaccine dose 1); 2 months - At the time of receipt of HPV vaccine dose 2 (to measure response to dose 1); 6 months - At the time of receipt of HPV vaccine dose 3 (to measure response to dose 2); 7 months - 1 month after HPV vaccine dose 3; 12 months - after HPV vaccine dose 1; 2 years after HPV vaccine dose 1; 3 years after HPV vaccine dose 1; 4 years after HPV vaccine dose 1; 5 years after HPV vaccine dose 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV vaccine | Experimental | Biological: Quadrivalent HPV vaccineQuadrivalent HPV vaccine |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- A platelet count of <50
- Immunoglobulin therapy within 3 months.
- Yeast allergy
- Any other known allergies to one of the vaccine component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent HPV vaccineThree 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. | Biological | HPV vaccine |
Primary outcome
Immunogenicity
Time frame: 2 years
Indicator: 1. Geometric mean four fold rises (with 95% confidence intervals) of the vaccine serotype specific IgG antibody in all participants. 2. 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.
1 secondary outcome
Duration of immunity
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 27406936MacIntyre CR, Shaw P, Mackie FE, Boros C, Marshall H, Barnes M, Seale H, Kennedy SE, Moa A, Hayen A, Chughtai AA, O'Loughlin EV, Stormon M. Immunogenicity and persistence of immunity of a quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2016 Aug 5;34(36):4343-50. doi: 10.1016/j.vaccine.2016.06.049. Epub 2016 Jul 9.
- Derived from this study: PubMed 31402238MacIntyre CR, Shaw PJ, Mackie FE, Boros C, Marshall H, Seale H, Kennedy SE, Moa A, Chughtai AA, Trent M, O'Loughlin EV, Stormon M. Long term follow up of persistence of immunity following quadrivalent Human Papillomavirus (HPV) vaccine in immunocompromised children. Vaccine. 2019 Sep 3;37(37):5630-5636. doi: 10.1016/j.vaccine.2019.07.072. Epub 2019 Aug 8.
- Individual participant dataSharing planned: No. We would like to share publication(s) that may arise from the study when applicable.
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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.
Raina MacIntyre principal investigator
The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent HPV vaccine in people with Autoimmune Disease and Juvenile Idiopathic Arthritis, run by The University of New South Wales 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 4 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: finished, as of the sponsor's last update on 8 May 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263703, which also lists 2 linked publications.
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 8 May 2024.