Long-term Immunogenicity of a HPV Vaccine in SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

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 16.5% 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 5.7% 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.
    

Intervention name(s): Vaccination
Intervention type(s): Biological
Intervention description(s): A quadrivalent HPV vaccine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        SLE patients

          1. Female patients aged 18-35 years

          2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification
             of SLE

          3. Having participated in the investigators' original HPV study in 2010

          4. Able to give written informed consent

        Controls

          1. Women aged 18-35 years, matched those of SLE patients recruited

          2. No known chronic medical diseases

          3. Having participated in our HPV study in 2010
      
Biospecimen description: 
      serum
    
Keywords: lupus