To examine the effect of BCG as an adjuvant on DTP vaccination, and to investigate the non-specific training effects of BCG and DTP, alone and in combination, on the innate immune system.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of pertussis-specific antibody and T-cell responses, as well as gene
transcription between BCG, TDaP-IPV and BCG+TDaP-IPV vaccinated groups.
Comparison of cytokine responses to unrelated antigens and/or pathogens before
and after BCG, TDaP-IPV or BCG+TDaP-IPV vaccination.
Secondary outcome
Epigenetic markers associated with immune function.
Background summary
The Bacillus Calmette-Guerin (BCG) vaccine not only protects against
Mycobacterium tuberculosis, but has also been shown to reduce morbidity and
mortality caused by non-related infections. This effect is likely due to
non-specific immunomodulatory effects, at least in part on the innate immune
system. Additionally, BCG has been shown to improve immunogenicity of other
vaccinations.
In contrast, whilst the diphtheria-tetanus-pertussis (DTP) combination vaccine
protects against infection with Bordetella pertussis, Clostridium tetani and
Corynebacterium diphtheria, it has also been associated with increased
mortality due to unrelated infections, particularly in girls in high-mortality
countries.
Although widespread DTP vaccination has initially reduced pertussis mortality,
the disease has persisted and recently resurged in a number of countries with
highly vaccinated populations, including the Netherlands. This has been
partially attributed to the switch from a whole-cell vaccine (which is still
being used in low-income countries) to a more defined acellular pertussis
vaccine, which only protects for a limited period (5-8 years). Strategies to
improve the efficacy of pertussis vaccination are therefore urgently required.
Study objective
To examine the effect of BCG as an adjuvant on DTP vaccination, and to
investigate the non-specific training effects of BCG and DTP, alone and in
combination, on the innate immune system.
Study design
Healthy volunteers will be divided in three groups. Group 1 will receive BCG
first, followed by Boostrix Polio (diphteria, tetanus, pertussis,
poliomyelitis) 3 months later. Group 2 will receive BCG and Boostrix Polio
simultaneously. Group 3 will first receive Boostrix polio, followed by BCG 3
month later. Blood will be taken before and at different timepoints after
vaccination.
Intervention
BCG vaccination
Vaccination with Boostrix Polio
Study burden and risks
There is no direct benefit to the study participants but these results will
potentially lead to novel strategies to optimize vaccinations. The risks for
participants are negligible, with the only expected risks being minor
side-effects from vaccination and local hematoma forming at the site of
venepuncture. This will be minimized by the performance of these procedures by
experienced personnel.
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Geert Grooteplein-Zuid 10
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Healthy adults
Exclusion criteria
Systemic medication other oral contraceptives. Diseases resulting in immunodeficiency. Previous BCG vaccination. Pregnancy.
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 | NL49814.091.14 |