Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
|Systemic Lupus Erythematosus||Drug: human papillomavirus vaccination (Gardasil)||Phase 4|
|Study Design:||Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With Systemic Lupus Erythematosus (SLE): a Controlled Study|
- antibody titers against 4 strains of human papillomavirus [ Time Frame: baseline, month 7 and month 12 ]
|Study Start Date:||October 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Vaccine arm
subjects receiving vaccination
Drug: human papillomavirus vaccination (Gardasil)
3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
Other Name: Gardasil
Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, especially those patients who are immunocompromised, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.
Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911521
|Department of Medicine, Tuen Mun Hospital|
|Hong Kong, China, 000|
|Principal Investigator:||Chi Chiu Mok, MD, FRCP||Tuen Mun Hospital, Hong Kong, China|