Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.
18 Years
50 Years
Female
Systemic Lupus Erythematosus
Trial Information
Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.
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®.
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., SELENDA-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 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To assess change in safety information and adverse events related to the use of Gardasil® in mild to moderate and minimally active or inactive SLE.
Outcome Time Frame:
1,61,66,181,186,211,330 days
Safety Issue:
Yes
Principal Investigator
Patricia J Dhar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wayne State University
Authority:
United States: Food and Drug Administration
Study ID:
0412GARDASIL
NCT ID:
NCT01741012
Start Date:
January 2013
Completion Date:
May 2014
Related Keywords:
- Systemic Lupus Erythematosus
- Lupus
- Lupus Erythematosus, Systemic
Name | Location |
|---|---|
| DCaTS-Clinical Research Center | Detroit, Michigan 48201 |
