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NCT Number: NCT02175420

Role of BCG as Booster Vaccination

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.

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Key information

Conditions

BCG Vaccination

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCG

Biological

Other names: BCG vaccine (SSI, Denmark)

TFV

Biological

Other names: Typhim Vi

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. Change in ex vivo cytokine responses

    Time frame: 0, 1 and 4 days; 2 weeks, 3 months

    Ex vivo cytokine response to unrelated antigens

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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