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Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients (GARDASIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01741012
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patricia Dhar, Wayne State University

Brief Summary:
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Gardasil Phase 1

Detailed Description:

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®.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Gardasil
0.5 ml single dose Gardasil vaccine given at three separate visits
Drug: Gardasil
0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6

Primary Outcome Measures :
  1. 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,

  2. Number of Non Vaccine Adverse Events [ Time Frame: 1,61,66,181,186,211,330 days ]
    the number of non vaccine adverse events

Secondary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Diagnosis of systemic lupus erythematosis (SLE) by the American College of Rheumatology (ACR) Criteria.

History of a positive antinuclear antibody (ANA) test result at any time in the past.

40 participants with history of mild to moderate SLE disease Minimally active or inactive SLE disease, i.e., (Safety of Estrogens in Lupus Erythematosis National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SELENA-SLEDAI ≤2 at the start of the study.

Age ≥ 18 years and ≤ 50 years. Gender: females Ability to provide informed consent. Maintenance Prednisone dose ≤ 15 mg/day. Plaquenil ≤ 400 mg/day.

Exclusion Criteria:

Hypersensitivity to any vaccine component Active infections including but not limited to human immunodeficiency virus (HIV positive), Hepatitis B or C, tuberculosis.

Positive purified protein derivative (PPD) test results without evidence of prior treatment or administration of bacilli Calmette-Guerin (BCG) vaccine. A positive PPD is defined as ≥ 5 mm induration 24-38 hours after receiving 5TU (TU=tuberculin units) of PPD.

Pregnancy or desire to become pregnant during the study period. Breast feeding. Inability to complete the immunization series. Received any blood product or component in the previous 6 months before enrollment.

Received any inactivated vaccine product within 14 days before enrollment. Received any live vaccine product within 21 days before enrollment.

Fever (temperature > 100°F) at the time of enrollment. Inability to provided informed consent.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01741012

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United States, Michigan
DCaTS-Clinical Research Center
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Merck Sharp & Dohme Corp.
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Principal Investigator: Patricia J Dhar, MD Wayne State University
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Patricia Dhar, Assistant Professor of Medicine, Wayne State University Identifier: NCT01741012    
Other Study ID Numbers: 0412GARDASIL
First Posted: December 4, 2012    Key Record Dates
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data will be shared with any researcher, only aggregated de-identified data
Keywords provided by Patricia Dhar, Wayne State University:
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases