This study is designed to dissect the immune response after Bp booster vaccination by investigating the kinetics of innate and adaptive immune cells, and detection and characterization of Bp-specific memory B cells and plasma cells.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detailed analysis of innate and adaptive immune cells and their kinetics in
time will be performed by the means of flow cytometry. Flow cytometry-based
approach will be developed to identify antigen specific memory B cells and
plasma cells prior to analysis of their immunoglobulin receptors by the means
of high throughput sequencing. Study will be finished while all donors are
recruited.
Secondary outcome
Not applicable
Background summary
Despite obligatory vaccinations against Bordetella pertussis (Bp), the number
of Bp infections is gradually increasing world-wide. This phenomenon seems to
be caused by the replacement of the whole cellular vaccine (containing whole
inactivated bacterium), by the acellular vaccine (containing purified bacteria
proteins).To prevent increased Bp infections it is crucial to investigate
immune responses to the currently used Bp vaccines and determine biomarkers
correlated with prediction of protection, long-lasting memory and early signs
of waning.
Study objective
This study is designed to dissect the immune response after Bp booster
vaccination by investigating the kinetics of innate and adaptive immune cells,
and detection and characterization of Bp-specific memory B cells and plasma
cells.
Study design
This is a minimally invasive study, including a booster immunization with a
certified vaccine and blood drawing.
Intervention
Volunteers will receive booster vaccination with Boostrix (GSK) after which
they will donate blood samples at various fixed time points.
Study burden and risks
Boostrix (GSK) is a vaccine used in a current vaccination scheme in the
Netherlands. Additional booster should result in increased immunity against
vaccine components, while the risk of severe adverse effects is limited. The
main burden for participants will be related to additional venous blood draws
following immunization.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Healthy competent adults, who have received recommended vaccinations according
to the vaccination policy in the Netherlands
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from
participation in this study:
* has an auto-immune disease
* has an immune deficiency
* has a bleeding disorder
* underwent splenectomy
* receives immunosuppressive medication
* receives medication which influences blood clotting
* underwent active (clinically manifested) Bordetella pertussis infection at
any time point in life or had contact with such a person
* received Bp vaccination in the past 10 years
* has Hb level below 8.5 mmol/L (male) or below 7.5 mmol/L (female)
* is pregnant or breast feeding
* had an allergic response to vaccination in the past
* received any vaccination within the 14 days prior to the study
* donated blood or plasma within the month prior to the study, or is planning
to donate within the first month of the study
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | EUCTR2016-002011-18-NL |
| CCMO | NL57973.058.16 |