Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Reproductive neoplasms female malignant and unspecified
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome immunogenicity is defined as the serological immune response
measured by antibody levels against HPV serotype 16 & 18. The antibody levels
will be measured prior to vaccination, and after 3, 7 and 12 months. Antibody
titers over time above the cutoffs 20 and 24 mMU/ml for HPV 16 and 18 or a >=2
fold increase in antibody titers against both serotypes are seen as a positive
response and will be analyzed in patients and healthy controls..
Secondary outcome
The secondary outcome is safety of vaccination, measured as activity of the
underlying disease. Other secondary outcomes are frequency of common adverse
effects, and immunological changes induced by HPV vaccination, such as number
and function of cytotoxic T cells and Tregs.
Background summary
Rationale:
In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to
the National Vaccination Program for girls to protect against the development
of cervical cancer. The vaccine protects against HPV type 16 & 18, which cause
about 75% of cervical cancer. Studies have shown that the vaccine is effective
in healthy subjects in preventing infection by HPV 16 & 18. However, no
evidence exists on the immunogenicity and safety of HPV vaccination in patients
with an immunesytem disorder, such as autoimmune diseases. Concerns exist that
vaccination may cause an aggravation of the underlying disease. In addition,
the immune response to vaccination may be diminished due to immunosuppressive
therapy or the underlying disease.
Study objective
Objective: The primary goal of the current study is to study the immunogenicity
and safety of HPV vaccination in patients with an autoimmune disease. Based on
retrospective analysis with other vaccines we hypothesize that patients with
autoimmune diseases who are under immunosuppressive medication and patients
with a immunesystem disorder are still able to mount a serological response to
HPV vaccination ( in case of humoral immunodeficiency we assume a protective
cellular immune response can be induced); that these HPV antibodies are
maintained; and that vaccination is safe. The secondary objective is to study
immune regulatory mechanisms induced by vaccination in a subset of patients. We
hypothesize HPV-induced regulatory T cells are able to prevent an increase in
the activity of an autoimmune disease.
Study design
Study design: multi center prospective observational cohort study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
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
venapunctures of the patients. However, one extra visit to the hospital and
vena puncture is expected. 4 ml (extra) blood is obtained four times from all
patients for serological analysis. Included healthy controls will have a
venapunctures four times during the study, during which 4mL of blood is
obtained. In a subset of patients (n=50) and healthy controls (n=15), an
additional 18 ml is obtained for immunological analysis.
Risks: participants may experience adverse events of the HPV vaccination.
Benefits: Protection against human Papillomavirusinfection and therefore
reduced risk of cervix carcinoma, certainty about protection against HPV 16 &
18 and about safety of HPV vaccination.
Group relatedness: This study can only be done in patients who need this
vaccination (i.e. females in the age group 12-17 years) and have an
immunesystem disorder, such as JIA, SLE, JDM.
PB 85090 -
Utrecht 3508AB
NL
PB 85090 -
Utrecht 3508AB
NL
Listed location countries
Age
Inclusion criteria
Females Who have one of the following immunsystem disorder:
a. Juvenile Idiopathic Arthritis
b. Systemic Lupus Erythematosus
c. Juvenile Dermatomyositis
Current co-medication: all co-medication such as Methotrexate, etanercept, anakinra or infliximab may be continued.
And who are in the following age groups:
a. 12 years (these girls are vaccinated via the National Vaccination Program from September 2009)
b. 13-17 years (these girls are vaccinated during a national vaccination campaign from March-May 2009)
Exclusion criteria
- Refusal to be vaccinated with the HPV vaccine
- Allergic reactions to one of the components of the vaccine.
- Acute, severe disease accompanied with fever. In this case, the moment of vaccination will be postponed for 1 month. A light infection, such as an upper airway infection, is not a reason to postpone the vaccination.
-Proven or suspected cervix carcinoma
-failure to comply
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-008169-36-NL |
| ClinicalTrials.gov | NCT00815282 |
| CCMO | NL26113.000.08 |