Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-07-31
2015-11-30
Brief Summary
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Apart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.
Several studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.
The study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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TFV alone
Typhim Vi
TFV
BCG+TFV
BCG (SSI, Denmark) followed after 14 days by Typhim Vi
BCG
TFV
Interventions
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BCG
TFV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Oral medication except anticonceptive drugs
* Previous vaccination with BCG and/or TFV
18 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mihai Netea, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, , Netherlands
Countries
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References
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Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.
Other Identifiers
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BCG-TFV1
Identifier Type: -
Identifier Source: org_study_id
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