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Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease

NCT00815282 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2017-11-13

No results posted yet for this study

Summary

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 immune system disorder, such as primary humoral immunodeficiency (i.e. hypogammaglobulinemia) or 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.

Objective: The primary goal of the current study is to study the immunogenicity of HPV vaccination in patients with an autoimmune disease and a primary humoral immunodeficiency.

Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune diseases who are under immunosuppressive medication and patients with a immune system disorder have a decreased serological response to HPV vaccination, and that the produced HPV antibodies titers decrease more rapidly than in healthy individuals.

The secondary objective is to explore safety of HPV vaccination and immune regulatory mechanisms induced by vaccination in a subset of patients. The investigators hypothesize that HPV vaccination is safe and that HPV-induced regulatory T cells are able to prevent an increase in the activity of an autoimmune disease.

Conditions

Interventions

OTHER

Human papilloma virus vaccine (cervarix)

vaccination at 0, 1 and 6 months

Sponsors & Collaborators

  • National Institute for Public Health and the Environment (RIVM)

    collaborator OTHER_GOV

  • N.M. Wulffraat

    lead OTHER

Principal Investigators

  • Nico M Wulffraat, MD, PhD · UMC Utrecht

  • Fiona van der KLis, MD, PhD · National Institute for Public Health and the Environment

  • Guy Berbers, PhD · National Institute for Public Health and the Environment

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00815282 on ClinicalTrials.gov