Systemic Lupus ErythematosusPhase 4NCT00911521
Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
A Phase 4 study testing human papillomavirus vaccination (Gardasil) in people with Systemic Lupus Erythematosus, run by Tuen Mun Hospital at 1 site in China.
Trial summary
The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- human papillomavirus vaccination (Gardasil)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Jun 2011
- Phase
- Phase 4
- 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 Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- SLE patients
- Female patients aged ≤ 35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
- Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
- Able to give written informed consent
- Controls
Show all 9Show fewer
- Women aged ≤ 35 years, matched those of SLE patients recruited
- No known chronic medical diseases
- Not receiving any long-term medications including herbs
Who cannot join
- History of allergy to HPV vaccines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled Study
The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.
Read the detailed description
Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, especially those patients who are immunocompromised, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- human papillomavirus vaccination (Gardasil)
- Keywords
- human papillomavirus, vaccine, 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.
human papillomavirus vaccination (Gardasil)Drug
Also called Gardasil
3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
| Study group | Role | What they receive |
|---|---|---|
| Vaccine arm | Active comparator | subjects receiving vaccination Receives: Drug: human papillomavirus vaccination (Gardasil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody titers against 4 strains of human papillomavirus
Measured: baseline, month 7 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionJun 2011
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- Chi Chiu Mok, MD, FRCP, Principal investigator, Tuen Mun Hospital, Hong Kong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911521
- Sponsor's protocol ID
- NTWC/CREC/704/09
- Status last verified
- Oct 2011
- First submitted
- 28 May 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled Study
- ClinicalTrials.gov ID
- NCT00911521
- Acronym / sponsor ID
- NTWC/CREC/704/09
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- human papillomavirus, vaccine, lupus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tuen Mun HospitalOther government
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Jun 2009 (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.
The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.
Detailed description
Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, especially those patients who are immunocompromised, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine arm | Active comparator | Drug: human papillomavirus vaccination (Gardasil)subjects receiving vaccination |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- SLE patients
- Female patients aged ≤ 35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
- Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
- Able to give written informed consent
Key exclusion criteria (1 listed)
- History of allergy to HPV vaccines
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 |
|---|---|---|
| human papillomavirus vaccination (Gardasil)Also: Gardasil3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6 | Drug | Vaccine arm |
Primary outcome
antibody titers against 4 strains of human papillomavirus
Time frame: baseline, month 7 and month 12
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 12 Oct 2011.
- 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.
Chi Chiu Mok, MD, FRCP principal investigator
Tuen Mun Hospital, Hong Kong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing human papillomavirus vaccination (Gardasil) in people with 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 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: finished, as of the sponsor's last update on 12 Oct 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
antibody titers against 4 strains of human papillomavirus (time frame: baseline, month 7 and month 12). 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 NCT00911521, 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 12 Oct 2011; AzTrials last refreshed its copy on 8 Nov 2026.