Primary Objective: • To develop new criteria for the interpretation of the IgG response to pneumococcal polysaccharide vaccination using serotype-specific normal values.Secondary Objectives: • To develop criteria for the interpretation of the IgG1,…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Distribution of serotype-specific IgG antibody titers to 13 pneumococcal
serotypes four weeks after vaccination.
Secondary outcome
Distribution of serotype-specific IgG antibody titers to 13 pneumococcal
serotypes eight weeks after vaccination.
Distribution of serotype-specific IgG1, IgG2, IgM and IgA antibody titers to 13
pneumococcal serotypes four and eight weeks after vaccination.
Distribution of serotype-specific percent change in IgG, IgG1, IgG2, IgM and
IgA antibody titers to 13 pneumococcal serotypes four and eight weeks after
vaccination in comparison to pre-vaccination.
Background summary
Polysaccharide vaccination can be used to assess the functioning of the humoral
immune system. An impaired response to vaccination supports the diagnosis of an
antibody deficiency, and can be an indication for starten immunoglobulin
substitution therapy.
However, the current classification of the response to pneumococcal
polysaccharide vaccination is not optimal. According to the current diagnostic
criteria over 40% of healthy individuals, will be classified as an impaired
responder. Because there is significant inter-serotype variation in
post-vaccination antibody levels, it should be endeavoured to develop
serotype-specific normal values, and study these in cohorts of healthy
individuals, as well as in patients with suspected or proven immunodeficiency.
Study objective
Primary Objective:
• To develop new criteria for the interpretation of the IgG response to
pneumococcal polysaccharide vaccination using serotype-specific normal values.
Secondary Objectives:
• To develop criteria for the interpretation of the IgG1, IgG2, IgM and IgA
response to pneumococcal polysaccharide vaccination using serotype-specific
normal values.
• To study the effect of age and gender on the response to pneumococcal
polysaccharide vaccination in healthy adults
Study design
Single-arm intervention study.
Intervention
One-time administration of the 23-valent pneumococcal polysaccharide vaccine.
Study burden and risks
These study procedures have negligible risk for adverse effects on patients*
health and/or well-being. The blood draws might cause some minor inconvenience,
but carry a negligible risk for any serious damage. Administration of the
vaccine might cause minor local side effects, and is associated with a very
small probability of more severe side effect. Importantly, the vaccine is
currently registered for use in all adults, to prevent pneumococcal infections.
Furthermore, nation-wide vaccination recommendations already include the
pneumococcal polysaccharide vaccine for healthy elderly because the risk of
serious harm was deemed to be very small. Potentially, participants will be
protected against invasive pneumococcal infections. 10 Otherwise, there are no
direct benefits that derive from participating in the study. We deem the
potential inconvenience caused by study procedures to be outweighed by the
potential benefits of the study results for future patients.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 years and <=80 years
• Fits within pre-specified age and gender stratification blocks
• Informed consent
Exclusion criteria
• Previous vaccination with pneumococcal polysaccharide or conjugate vaccination
• Chronic disease that requires the use of immunosuppressive agents
• Known or highly suspected primary or secondary immunodeficiency
• Pregnancy
• Fever or active infection
• History of allergic reaction to one of the vaccine components
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 | EUCTR2019-001118-40-NL |
| CCMO | NL69183.100.19 |