Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients (GARDASIL)
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|ClinicalTrials.gov Identifier: NCT01741012|
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Gardasil||Phase 1|
To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE.
To gather information on SLE disease activity flares after vaccination with Gardasil®.
To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||November 2015|
0.5 ml single dose Gardasil vaccine given at three separate visits
0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
- Frequency of Participants With Adverse Events [ Time Frame: 1,61,66,181,186,211,330 days ]Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
- Number of Non Vaccine Adverse Events [ Time Frame: 1,61,66,181,186,211,330 days ]the number of non vaccine adverse events
- Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer [ Time Frame: Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study. ]1. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18
- SLE Disease Activity Flares [ Time Frame: 1,61,66,181,186,211,330 days ]SELENA-SLEDAI measurements > or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of >2.
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): NCT01741012
|United States, Michigan|
|DCaTS-Clinical Research Center|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Patricia J Dhar, MD||Wayne State University|