Systemic Lupus ErythematosusNCT00786409
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
A study testing Gardasil in people with Systemic Lupus Erythematosus, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women. Read more about this study
- Who is it for?
- Ages 9 to 26 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Gardasil
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2011
- Phase
- Interventional
- 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 9 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 9 to 26 years of age
- Gender: Female
- All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
- Current SLEDAI score ≤ 6
- Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment
Who cannot join
- Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
- Current SLEDAI score > 6
- Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous administration of any HPV vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
The purpose of this study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
Read the detailed description
Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.
The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Gardasil
- 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.
GardasilBiological
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Gardasil | Other | 30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6. Receives: Biological: Gardasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV 6 Seroconversion
Percent Seropositive
Measured: 7 months
Anti-HPV 6 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Measured: 7 months
Anti-HPV 11 Seroconversion
% Seropositive
Measured: 7 months
Anti-HPV 11 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Measured: 7 months
Anti-HPV 16 Seroconversion
% Seropositive
Measured: 7 months
Anti-HPV 16 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Measured: 7 months
Anti-HPV 18 Seroconversion
% Seropositive
Measured: 7 months
Anti-HPV 18 GMT
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Measured: 7 months
SLEDAI Change Score
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.
Measured: 7 months
Secondary outcomes (3)
Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP
Measured: 7 months
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)
Measured: 7 months
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2010
- Study completionDec 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Linda Wagner-Weiner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786409
- Sponsor's protocol ID
- 15960A
- Other IDs
- MERCK: MISP for Gardasil#33598
- Status last verified
- Feb 2018
- First submitted
- 5 Nov 2008
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25. doi: 10.1002/art.22667.
PubMed 17471531
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26
- ClinicalTrials.gov ID
- NCT00786409
- Acronym / sponsor ID
- 15960A
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 15 Feb 2018
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 study is to evaluate the immunogenicity and safety of the HPV vaccine Gardasil in young women.
Detailed description
Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies.
The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gardasil | Other | Biological: Gardasil30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age: 9 to 26 years of age
- Gender: Female
- All patients must fulfill the revised American College of Rheumatology Classification Criteria for SLE diagnosis.
- Current SLEDAI score ≤ 6
- Written, witnessed informed consent and/or assent will be obtained from the subject and the subject's parents (if under 18 years of age) or legally acceptable representative prior to enrollment
Key exclusion criteria (5 listed)
- Acute exacerbation of disease within past 30 days which required increase in corticosteroid dose, initiation of a new immunosuppressive medication, or hospitalization
- Current SLEDAI score > 6
- Patients who have received rituximab in the last 6 months, or are currently on cyclophosphamide treatment
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous administration of any HPV vaccine
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 |
|---|---|---|
| Gardasil0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6. | Biological | Gardasil |
Primary outcome
Anti-HPV 6 Seroconversion
Time frame: 7 months
Percent Seropositive
Anti-HPV 6 GMT
Time frame: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 11 Seroconversion
Time frame: 7 months
% Seropositive
Anti-HPV 11 GMT
Time frame: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 16 Seroconversion
Time frame: 7 months
% Seropositive
Anti-HPV 16 GMT
Time frame: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
Anti-HPV 18 Seroconversion
Time frame: 7 months
% Seropositive
Anti-HPV 18 GMT
Time frame: 7 months
Geometric mean titre in milli-Merck units per ml (mMu/ml)
SLEDAI Change Score
Time frame: 7 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.
3 secondary outcomes
Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP
Time frame: 7 months
Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)
Time frame: 7 months
Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17471531Nath R, Mant C, Luxton J, Hughes G, Raju KS, Shepherd P, Cason J. High risk of human papillomavirus type 16 infections and of development of cervical squamous intraepithelial lesions in systemic lupus erythematosus patients. Arthritis Rheum. 2007 May 15;57(4):619-25. doi: 10.1002/art.22667.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Linda Wagner-Weiner, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardasil in people with Systemic Lupus Erythematosus, run by University of Chicago at 1 site in United States.
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 5 inclusion and 5 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 15 Feb 2018. 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 United States. 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 Feb 2018). 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?
Anti-HPV 6 Seroconversion (time frame: 7 months). The study lists 9 primary outcomes in all. 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 NCT00786409, 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 15 Feb 2018.