Role of BCG as Booster Vaccination

Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02175420

Enrollment

Registered

2014-06-26

Start date

2012-07-31

Completion date

2015-11-30

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BCG Vaccination

Keywords

BCG, Salmonella, Trained immunity, Non-specific effect vaccines

Brief summary

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.

Interventions

BIOLOGICALBCG

BIOLOGICALTFV

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Born in Salmonella typhi endemic country * Pregnancy * Oral medication except anticonceptive drugs * Previous vaccination with BCG and/or TFV

Design outcomes

Primary

Measure	Time frame	Description
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV	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	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.

Secondary

Measure	Time frame	Description
Change in ex vivo cytokine responses	0, 1 and 4 days; 2 weeks, 3 months	Ex vivo cytokine response to unrelated antigens

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026