NCT02175420|Completed
Role of BCG as Booster Vaccination
Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
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Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
Sponsor study identifier
interventional
30
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
November 2015
Actual (reported)The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2014
Actual (reported)June 26, 2014
Actual (reported)April 2015
Actual (reported)November 2015
Actual (reported)anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV
anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.
2 weeks
anti-salmonella typhi Vi antigen antibody titer 3 months post TFV
anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.
3 months
Change in ex vivo cytokine responses
0, 1 and 4 days; 2 weeks, 3 months
Typhim Vi
BCG (SSI, Denmark) followed after 14 days by Typhim Vi
Radboudumc
Nijmegen, 6500HB, Netherlands
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.
Mihai Netea, Prof. Dr.
Radboud University Medical Center
30 participants (actual enrollment reported by the registry).
First Submitted
June 20, 2014
First Posted
June 26, 2014
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
April 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
February 23, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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