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

Systemic Lupus Erythematosus Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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®. ;

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT01741012
• Study type: Interventional
• Source: Wayne State University
• Status: Completed
• Phase: Phase 1
• Start date: January 2013
• Completion date: November 2015