Clinical trial NCT01741012: Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
Official title: Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-12-04
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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®.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Participants With Adverse Events
timeFrame: 1,61,66,181,186,211,330 days
measure: Number of Non Vaccine Adverse Events
timeFrame: 1,61,66,181,186,211,330 days
Secondary outcomes:
measure: Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
timeFrame: 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.
measure: SLE Disease Activity Flares
timeFrame: 1,61,66,181,186,211,330 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: DCaTS-Clinical Research Center
state: Michigan
Study officials:
affiliation: Wayne State University
name: Patricia J Dhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhar JP, Essenmacher L, Dhar R, Magee A, Ager J, Sokol RJ. The safety and immunogenicity of Quadrivalent HPV (qHPV) vaccine in systemic lupus erythematosus. Vaccine. 2017 May 9;35(20):2642-2646. doi: 10.1016/j.vaccine.2017.04.001. Epub 2017 Apr 9.