To identify complement donors with no or low antibodies to Meningococcal strains to be used used as a complement source in SBAs against a panel of meningococci during evaluation of clinical trial samples
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
N.A.
Secondary outcome
N.A.
Background summary
Due to the severity of the disease, challenge studies are unethical. Therefore,
existing meningococcal vaccines have been licensed using the results of an in
vitro surrogate of protection: the Serum Bactericidal Assay (SBA) .
In this study, suitable complement donors will be identified whose serum can be
used as a complement source in SBAs against a panel of meningococci during
evaluation of clinical trial samples
Study objective
To identify complement donors with no or low antibodies to Meningococcal
strains to be used used as a complement source in SBAs against a panel of
meningococci during evaluation of clinical trial samples
Study design
Observational study in healthy volunteers.
Study burden and risks
Risk regarding blood drawing: risk to bruise or infection
Archimedesweg 4-6
Leiden 2333 CN
NL
Archimedesweg 4-6
Leiden 2333 CN
NL
Listed location countries
Age
Inclusion criteria
Healthy males and females
Exclusion criteria
Currently taking antibiotics or have taken antibiotics in the 2 weeks preceding blood collection.
Having had any vaccination in the 2 weeks preceding blood collection.
Blood donation outside the limits of Sanquin
Design
Recruitment
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 |
|---|---|
| CCMO | NL46901.058.13 |