Systemic Lupus ErythematosusNCT02477254
Long-term Immunogenicity of a HPV Vaccine in SLE
An observational study of Systemic Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
Trial summary
To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Oct 2016
- Phase
- Observational
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: SLE patients 1. Female patients aged 18-35 years 2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE 3. Having participated in the investigators' original HPV study in 2010 4. Able to give written informed consent Controls 1. Women aged 18-35 years, matched those of SLE patients recruited 2. No known chronic medical diseases 3. Having participated in our HPV study in 2010
Who may be able to join
- SLE patients
- Female patients aged 18-35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
- Having participated in the investigators' original HPV study in 2010
- Able to give written informed consent
- Controls
Show all 9Show fewer
- Women aged 18-35 years, matched those of SLE patients recruited
- No known chronic medical diseases
- Having participated in our HPV study in 2010
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control Study
To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls.
Read the detailed description
Most cases of human papilloma virus (HPV) infection are asymptomatic, transient and resolve without treatment. However, in some individuals, especially those patients who are immunocompromised because of various underlying diseases and those who are receiving long-term immunosuppressive agents, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
High-risk HPV serotypes are those which are oncogenic and associated with invasive cancers of the cervix and vulva. Examples are the HPV 16 and HPV 18. HPV 16 accounts for almost half of all cervical cancers whereas HPV 18 infection is present in 10-12% of all cervical cancers.
Systemic lupus erythematosus (SLE) patients are at risk of persistent HPV infection. This is because of the immune aberration related to the disease itself and the immunosuppressive state induced by various treatments. One study of 85 SLE patients revealed a 16.5% prevalence of abnormal Pap smears and 12% prevalence of cervical squamous intraepithelial neoplasia (CIN) on routine screening, which was significantly higher than those figures reported in age-matched healthy women (corresponding figures for abnormal Pap smear and CIN were 5.7% and 2%, respectively). Thus, prevention of HPV infection is important in patients with SLE in order to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The investigators have conducted a case-control study on the safety and immunogenicity of the quadrivalent HPV vaccine, GARDASIL, in 2010. Fifty female SLE patients and 50 age-matched healthy controls were studied. At month 12 after vaccination, the sero-conversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. Injection site reaction was the commonest adverse event (AE) (5%), and the incidence of AEs was comparable between patients with SLE and controls.
The investigators plan to study the long-term immunogenicity (durability of the immune response) of the HPV vaccine in the same cohort of patients and controls followed for 5 years. In particular, in patients with SLE, the investigators would like to evaluate the effect of disease flares and ongoing immunosuppressive treatment on the immune response to the HPV serotypes 5 years after vaccination.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Vaccination
- Keywords
- lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBiological
A quadrivalent HPV vaccine
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | SLE patients who received HPV vaccination Receives: Biological: Vaccination | |
| Control subjects | Healthy subjects who received HPV vaccination Receives: Biological: Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
proportion of subjects in each arm who remains sero-converted for each HPV serotype at 5 years after vaccination
Measured: 5 years
Secondary outcomes (1)
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
the change in anti-HPV titers at 5 years as compared to 12 months post-vaccination
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 posted22 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuen Mun Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chi Chiu Mok, Tuen Mun Hospital
- Investigators
- CC Mok, MD, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477254
- Sponsor's protocol ID
- NTWC/CREC/15035
- Status last verified
- Oct 2016
- First submitted
- 17 Jun 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mok CC, Ho LY, To CH. Long-term immunogenicity of a quadrivalent human papillomavirus vaccine in systemic lupus erythematosus. Vaccine. 2018 May 31;36(23):3301-3307. doi: 10.1016/j.vaccine.2018.04.056. Epub 2018 Apr 24.
PubMed 29699792
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Immunogenicity of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus: a Case-control Study
- ClinicalTrials.gov ID
- NCT02477254
- Acronym / sponsor ID
- NTWC/CREC/15035
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Jun 2015 (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.
To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls.
Detailed description
Most cases of human papilloma virus (HPV) infection are asymptomatic, transient and resolve without treatment. However, in some individuals, especially those patients who are immunocompromised because of various underlying diseases and those who are receiving long-term immunosuppressive agents, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
High-risk HPV serotypes are those which are oncogenic and associated with invasive cancers of the cervix and vulva. Examples are the HPV 16 and HPV 18. HPV 16 accounts for almost half of all cervical cancers whereas HPV 18 infection is present in 10-12% of all cervical cancers.
Systemic lupus erythematosus (SLE) patients are at risk of persistent HPV infection. This is because of the immune aberration related to the disease itself and the immunosuppressive state induced by various treatments. One study of 85 SLE patients revealed a 16.5% prevalence of abnormal Pap smears and 12% prevalence of cervical squamous intraepithelial neoplasia (CIN) on routine screening, which was significantly higher than those figures reported in age-matched healthy women (corresponding figures for abnormal Pap smear and CIN were 5.7% and 2%, respectively). Thus, prevention of HPV infection is important in patients with SLE in order to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The investigators have conducted a case-control study on the safety and immunogenicity of the quadrivalent HPV vaccine, GARDASIL, in 2010. Fifty female SLE patients and 50 age-matched healthy controls were studied. At month 12 after vaccination, the sero-conversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. Injection site reaction was the commonest adverse event (AE) (5%), and the incidence of AEs was comparable between patients with SLE and controls.
The investigators plan to study the long-term immunogenicity (durability of the immune response) of the HPV vaccine in the same cohort of patients and controls followed for 5 years. In particular, in patients with SLE, the investigators would like to evaluate the effect of disease flares and ongoing immunosuppressive treatment on the immune response to the HPV serotypes 5 years after vaccination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | Biological: VaccinationSLE patients who received HPV vaccination |
| Control subjects | – | Biological: VaccinationHealthy subjects who received HPV vaccination |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- SLE patients 1. Female patients aged 18-35 years 2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE 3. Having participated in the investigators' original HPV study in 2010 4. Able to give written informed consent Controls 1. Women aged 18-35 years, matched those of SLE patients recruited 2. No known chronic medical diseases 3. Having participated in our HPV study in 2010
Key inclusion criteria (9 listed)
- SLE patients
- Female patients aged 18-35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
- Having participated in the investigators' original HPV study in 2010
- Able to give written informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VaccinationA quadrivalent HPV vaccine | Biological | Control subjects, SLE patients |
Primary outcome
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
Time frame: 5 years
proportion of subjects in each arm who remains sero-converted for each HPV serotype at 5 years after vaccination
1 secondary outcome
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
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 19 Oct 2016.
- Derived from this study: PubMed 29699792Mok CC, Ho LY, To CH. Long-term immunogenicity of a quadrivalent human papillomavirus vaccine in systemic lupus erythematosus. Vaccine. 2018 May 31;36(23):3301-3307. doi: 10.1016/j.vaccine.2018.04.056. Epub 2018 Apr 24.
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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.
CC Mok, MD principal investigator
Tuen Mun 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 Systemic Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
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 9 inclusion and 0 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 19 Oct 2016. 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 China. 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?
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?
Neutralizing antibodies to HPV serotypes 6,11,16 and 18 (time frame: 5 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 NCT02477254, which also lists 1 linked publication.
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 19 Oct 2016.