Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wayne State University
With
Merck Sharp & Dohme LLC
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®.
Age
18–50
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
