Role of BCG as Booster Vaccination

February 22, 2016 updated by: Radboud University Medical Center

Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TFV alone
Typhim Vi
Biological: TFV
Other Names:
  • Typhim Vi
Experimental: BCG+TFV
BCG (SSI, Denmark) followed after 14 days by Typhim Vi
Biological: BCG
Other Names:
  • BCG vaccine (SSI, Denmark)
Biological: TFV
Other Names:
  • Typhim Vi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Mihai Netea, Prof. Dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCG-TFV1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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