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Role of BCG as Booster Vaccination

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ClinicalTrials.gov Identifier: NCT02175420
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
BCG Vaccination Biological: BCG Biological: TFV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine
Study Start Date : July 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TFV alone
Typhim Vi
Biological: TFV
Other Name: Typhim Vi

Experimental: BCG+TFV
BCG (SSI, Denmark) followed after 14 days by Typhim Vi
Biological: BCG
Other Name: BCG vaccine (SSI, Denmark)

Biological: TFV
Other Name: Typhim Vi




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175420


Locations
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Netherlands
Radboudumc
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Mihai Netea, Prof. Dr. Radboud University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02175420    
Other Study ID Numbers: BCG-TFV1
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Keywords provided by Radboud University:
BCG
Salmonella
Trained immunity
Non-specific effect vaccines
Additional relevant MeSH terms:
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BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic