Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
| Status: | Completed |
|---|---|
| Conditions: | Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/7/2018 |
| Start Date: | January 2013 |
| End Date: | November 2015 |
Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.
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.
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.
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®.
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., (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.
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: Patricia Dhar, MD
Phone: 313-577-1579
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