NCT01741012

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

Phase I, Safety and Immunogenicity of Gardasil® in Systemic Lupus Erythematosus.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Gardasil	0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-01-01
• Completion: 2015-11-01
• First posted: 2012-12-04
• Last updated: 2018-11-05
• Results posted: 2018-11-05

Locations

1 site across 1 country: United States