Role of BCG as Booster Vaccination
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|ClinicalTrials.gov Identifier: NCT02175420|
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : February 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|BCG Vaccination||Biological: BCG Biological: TFV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||November 2015|
Active Comparator: TFV alone
Other Name: Typhim Vi
BCG (SSI, Denmark) followed after 14 days by Typhim Vi
Other Name: BCG vaccine (SSI, Denmark)
Other Name: Typhim Vi
- anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV [ Time Frame: 2 weeks ]anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.
- anti-salmonella typhi Vi antigen antibody titer 3 months post TFV [ Time Frame: 3 months ]anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.
- Change in ex vivo cytokine responses [ Time Frame: 0, 1 and 4 days; 2 weeks, 3 months ]Ex vivo cytokine response to unrelated antigens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175420
|Nijmegen, Netherlands, 6500HB|
|Principal Investigator:||Mihai Netea, Prof. Dr.||Radboud University|