Study of the value of alternative methods to pneumococcal polysaccharide vaccine response for diagnosis of a specific polysaccharide antibody deficiency. Specific polysaccharide antibody deficiency is an immunodeficiency characterized by a deficient production of antibodies to the cell wall of encapsulated bacteria, leading to recurrent ENT and lung infections.
- Conditions
- Specific polysaccharide antibody deficiency.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2014-003007-29-BE
- Lead Sponsor
- niversity Hospitals Leuven, department of pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Cohort 1:
Subjects, in whom humoral immunity is evaluated, will be included in cohort 1 when the below-mentioned criteria are fulfilled.
• Assessment of polysaccharide antibody response is indicated for the clinical care of the patient
• Age between 18 months and 55 years
• Informed consent given
Cohort 2:
Healthy volunteers, recruited at the travel clinic and by advertising, will be included in cohort 2 when the below-mentioned criteria are fulfilled.
• Age between 18 months and 55 years
• Informed consent given
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Age >55 years
• Age <18 months
• History of serious adverse reaction to a vaccine
• Vaccination with Typhim or Pneumovax 23 in 5 years prior to the study
• Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method