Role of BCG as Booster Vaccination

Not Applicable

Completed

• Conditions: BCG Vaccination
• Interventions: Biological: BCG; Biological: TFV

• Registration Number: NCT02175420
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Primary Completion: 2015-04
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy volunteers

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Exclusion Criteria

• Born in Salmonella typhi endemic country
• Pregnancy
• Oral medication except anticonceptive drugs
• Previous vaccination with BCG and/or TFV

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCG+TFV	BCG	BCG (SSI, Denmark) followed after 14 days by Typhim Vi
TFV alone	TFV	Typhim Vi
BCG+TFV	TFV	BCG (SSI, Denmark) followed after 14 days by Typhim Vi

Primary Outcome Measures

Name	Time	Method
anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV	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.
anti-salmonella typhi Vi antigen antibody titer 3 months post TFV	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

Name	Time	Method
Change in ex vivo cytokine responses	0, 1 and 4 days; 2 weeks, 3 months	Ex vivo cytokine response to unrelated antigens

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands