Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
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|ClinicalTrials.gov Identifier: NCT00786409|
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Biological: Gardasil||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of the Quadrivalent HPV Vaccine Gardasil in Female Systemic Lupus Erythematosus Patients Aged 9-26|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||December 2011|
30 patients will receive 0.5 ml Gardasil vaccine at months 0,2, and 6.
0.5 ml Gardasil vaccine will be administered to each patient at months 0,2 and 6.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786409
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Linda Wagner-Weiner, MD||University of Chicago|