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Role of BCG as Booster Vaccination

NCT02175420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-02-23

No results posted yet for this study

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.

Conditions

  • BCG Vaccination

Interventions

BIOLOGICAL

BCG

BIOLOGICAL

TFV

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Mihai Netea, Prof. Dr. · Radboud University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-04-30
Completion
2015-11-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02175420 on ClinicalTrials.gov