Role of BCG as Booster Vaccination

BCG Vaccination Clinical Trial

Official title:

Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175420
• Other study ID #: BCG-TFV1
• Status: Completed
• Phase: N/A
• First received: June 20, 2014
• Last updated: February 22, 2016
• Start date: July 2012
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• BCG Vaccination

Intervention

Biological:
• BCG

• TFV

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV	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	No
Primary	anti-salmonella typhi Vi antigen antibody titer 3 months post TFV	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	No
Secondary	Change in ex vivo cytokine responses	Ex vivo cytokine response to unrelated antigens	0, 1 and 4 days; 2 weeks, 3 months	No