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Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

Phase 4
12 Years
18 Years
Open (Enrolling)
Juvenile Idiopathic Arthritis, Systemic Lupus Erythematosus, Juvenile Dermatomyositis

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Trial Information

Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

Study design: prospective observational cohort study.

Study population: Females aged 12 - 18 years with one of the autoimmune diseases Juvenile
Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE) and Juvenile Dermatomyositis
(JDM) are included. Included females are treated at the rheumatology unit from the
University Medical Center Utrecht. A small control group of healthy girls aged 13 -17 years
will also be included to compare the kinetics of HPV serology with healthy individuals.

Intervention: Starting from September 2009 all girls aged 12 years will be offered a HPV
vaccination via the National Vaccination Program. Prior to this, a national campaign will be
started in March 2009 to vaccinate all girls aged 13-17 years at once.We will use this
national vaccination campaign as an opportunity to analyze the serological response and
safety of this vaccine in a large group of with an immune system disorder. The vaccines are
administered by our national health organisation. The effects are monitored in our clinics.

Main study parameters/endpoints:

- Primary outcome immunogenicity is measured by antibody levels against HPV serotype 16 &
18 over time. We consider HPV vaccination to be immunogenic at antibody titers above
the cutoffs 20 and 24 mMU/ml for HPV 16 and 18, respectively; or at a ≥2 fold increase
in antibody levels against both serotypes. The antibody levels will be measured prior
to vaccination, and after 3,7 and 12 months.

- The secondary outcome is safety of vaccination, measured as activity of the underlying
autoimmune disease. In addition, frequency of common adverse effects, and immunological
changes induced by HPV vaccination, such as number and function of cytotoxic T cells
and Tregs will be described.

Nature and extent of the burden and risks associated with participation, benefit and group

Burden: included patients will be asked to visit the hospital 4 times in a period of 12
months. During these visits, physical examination will be performed and blood will be
obtained for serological and immunological analysis. Most of these visits are combined with
routine follow-up and venous punctures of the patients. However, one extra visit to the
hospital and vena puncture is expected. 5 ml (extra) blood is obtained four times from all
patients for serological analysis. Included healthy controls will be asked to visit one
plenary information meeting in the evening. Controls will have a venous punctures four times
during the study, during which 5 ml of blood is obtained. These samples will be obtained at
the hospital during evening clinics or at school. In a subset of patients (n=50) and healthy
controls (n=10), an additional 15 ml is obtained for immunological analysis.

Risks: participants may experience adverse events of the HPV vaccination. Benefits:
Protection against human Papillomavirus infection and therefore reduced risk of cervix
carcinoma, certainty about protection against HPV 16 & 18 and about safety of HPV

Group relatedness: This study can only be done in patients who need this vaccination (i.e.
females in the age group 12-24 years) and have an immune system disorder, such as JIA, SLE
or JDM. Appropriate comparison with healthy controls must be performed in age-matched
healthy females who are also recruited for the National HPV vaccination campaign, in this
case girls in the age group 13-17 years.

Inclusion Criteria:

- Females

- Clinical diagnosis of JIA, SLE or JDM

- And who are in the following age groups:

- 12 years (these girls are vaccinated via the National Vaccination Program from
September 2009)

- 13-18 years (these girls are vaccinated during a national vaccination campaign
from March-May 2009)

- Current co-medication: all co-medication prescribed may be continued

- And in the control group: healthy girls aged 13-17 years (these girls are vaccinated
during a national vaccination campaign from March-May 2009)

Exclusion Criteria:

- No HPV vaccination

- Refusal to allow venous puncture

- Proven or suspected cervical carcinoma

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

the immunogenicity of HPV vaccination in patients with immune system disorders. The immunogenicity of HPV vaccination in patients will be compared to healthy controls, measured by antibody levels against HPV serotype 16 & 18.

Outcome Time Frame:

0, 3, 7, 12 months

Safety Issue:


Principal Investigator

Nico M Wulffraat, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht


Netherlands: Ministry of Health, Welfare and Sport

Study ID:




Start Date:

February 2009

Completion Date:

December 2013

Related Keywords:

  • Juvenile Idiopathic Arthritis
  • Systemic Lupus Erythematosus
  • Juvenile Dermatomyositis
  • Arthritis
  • Autoimmune Diseases
  • Dermatomyositis
  • Lupus Erythematosus, Systemic
  • Arthritis, Juvenile Rheumatoid