Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chi Chiu Mok, Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00911521
First received: May 28, 2009
Last updated: October 9, 2011
Last verified: October 2011
  Purpose

The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: human papillomavirus vaccination (Gardasil)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • antibody titers against 4 strains of human papillomavirus [ Time Frame: baseline, month 7 and month 12 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

SLE patients

  • Female patients aged ≤ 35 years
  • Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
  • Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
  • Able to give written informed consent

Controls

  • Women aged ≤ 35 years, matched those of SLE patients recruited
  • No known chronic medical diseases
  • Not receiving any long-term medications including herbs

Exclusion Criteria:

  • History of allergy to HPV vaccines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911521

Locations
China
Department of Medicine, Tuen Mun Hospital
Hong Kong, China, 000
Sponsors and Collaborators
Tuen Mun Hospital
Investigators
Principal Investigator: Chi Chiu Mok, MD, FRCP Tuen Mun Hospital, Hong Kong, China
  More Information

No publications provided

Responsible Party: Chi Chiu Mok, Consultant, Tuen Mun Hospital
ClinicalTrials.gov Identifier: NCT00911521     History of Changes
Other Study ID Numbers: NTWC/CREC/704/09
Study First Received: May 28, 2009
Last Updated: October 9, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:
human papillomavirus
vaccine
lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014