Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02477254
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2015-06-17
Brief Title:
Long-term Immunogenicity of a HPV Vaccine in SLE
Sponsor:
Tuen Mun Hospital
Organization:
Tuen Mun Hospital
Study Overview
Official Title:
Long-term Immunogenicity of a Quadrivalent Human Papillomavirus HPV Vaccine in Patients With Systemic Lupus Erythematosus a Case-control Study
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls
Detailed Description:
Most cases of human papilloma virus HPV infection are asymptomatic transient and resolve without treatment However in some individuals especially those patients who are immunocompromised because of various underlying diseases and those who are receiving long-term immunosuppressive agents HPV infection is persistent and may result in genital warts cervical smear abnormalities cervical intraepithelial neoplasia CIN and rarely cervical cancer
High-risk HPV serotypes are those which are oncogenic and associated with invasive cancers of the cervix and vulva Examples are the HPV 16 and HPV 18 HPV 16 accounts for almost half of all cervical cancers whereas HPV 18 infection is present in 10-12 of all cervical cancers
Systemic lupus erythematosus SLE patients are at risk of persistent HPV infection This is because of the immune aberration related to the disease itself and the immunosuppressive state induced by various treatments One study of 85 SLE patients revealed a 165 prevalence of abnormal Pap smears and 12 prevalence of cervical squamous intraepithelial neoplasia CIN on routine screening which was significantly higher than those figures reported in age-matched healthy women corresponding figures for abnormal Pap smear and CIN were 57 and 2 respectively Thus prevention of HPV infection is important in patients with SLE in order to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run
The investigators have conducted a case-control study on the safety and immunogenicity of the quadrivalent HPV vaccine GARDASIL in 2010 Fifty female SLE patients and 50 age-matched healthy controls were studied At month 12 after vaccination the sero-conversion rates of anti-HPV serotypes 6 11 16 and 18 in patients and controls were 82 89 95 76 and 98 98 98 80 respectively Injection site reaction was the commonest adverse event AE 5 and the incidence of AEs was comparable between patients with SLE and controls
The investigators plan to study the long-term immunogenicity durability of the immune response of the HPV vaccine in the same cohort of patients and controls followed for 5 years In particular in patients with SLE the investigators would like to evaluate the effect of disease flares and ongoing immunosuppressive treatment on the immune response to the HPV serotypes 5 years after vaccination
High-risk HPV serotypes are those which are oncogenic and associated with invasive cancers of the cervix and vulva Examples are the HPV 16 and HPV 18 HPV 16 accounts for almost half of all cervical cancers whereas HPV 18 infection is present in 10-12 of all cervical cancers
Systemic lupus erythematosus SLE patients are at risk of persistent HPV infection This is because of the immune aberration related to the disease itself and the immunosuppressive state induced by various treatments One study of 85 SLE patients revealed a 165 prevalence of abnormal Pap smears and 12 prevalence of cervical squamous intraepithelial neoplasia CIN on routine screening which was significantly higher than those figures reported in age-matched healthy women corresponding figures for abnormal Pap smear and CIN were 57 and 2 respectively Thus prevention of HPV infection is important in patients with SLE in order to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run
The investigators have conducted a case-control study on the safety and immunogenicity of the quadrivalent HPV vaccine GARDASIL in 2010 Fifty female SLE patients and 50 age-matched healthy controls were studied At month 12 after vaccination the sero-conversion rates of anti-HPV serotypes 6 11 16 and 18 in patients and controls were 82 89 95 76 and 98 98 98 80 respectively Injection site reaction was the commonest adverse event AE 5 and the incidence of AEs was comparable between patients with SLE and controls
The investigators plan to study the long-term immunogenicity durability of the immune response of the HPV vaccine in the same cohort of patients and controls followed for 5 years In particular in patients with SLE the investigators would like to evaluate the effect of disease flares and ongoing immunosuppressive treatment on the immune response to the HPV serotypes 5 years after vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None