Role of BCG as Booster Vaccination

NCT ID: NCT02175420

Last Updated: 2016-02-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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BCG Vaccination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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TFV alone

Typhim Vi

Group Type ACTIVE_COMPARATOR

TFV

Intervention Type BIOLOGICAL

BCG+TFV

BCG (SSI, Denmark) followed after 14 days by Typhim Vi

Group Type EXPERIMENTAL

BCG

Intervention Type BIOLOGICAL

TFV

Intervention Type BIOLOGICAL

Interventions

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BCG

Intervention Type BIOLOGICAL

TFV

Intervention Type BIOLOGICAL

Other Intervention Names

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BCG vaccine (SSI, Denmark) Typhim Vi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Netherlands

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.

Reference Type DERIVED
PMID: 32065303 (View on PubMed)

Other Identifiers

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BCG-TFV1

Identifier Type: -

Identifier Source: org_study_id

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