Role of BCG as Booster Vaccination

NCT02175420 | Completed

• 1 other identifier: BCG-TFV1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

BCG Vaccination

Keywords

BCG; Salmonella; Trained immunity; Non-specific effect vaccines

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Change in ex vivo cytokine responses

  0, 1 and 4 days; 2 weeks, 3 months

Study Arms (2)

TFV alone

ACTIVE COMPARATOR

Typhim Vi

Biological: TFV

BCG+TFV

EXPERIMENTAL

BCG (SSI, Denmark) followed after 14 days by Typhim Vi

Biological: BCG; Biological: TFV

Interventions

BCG BIOLOGICAL

Also known as: BCG vaccine (SSI, Denmark)

BCG+TFV

TFV BIOLOGICAL

Also known as: Typhim Vi

BCG+TFV; TFV alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6500HB, Netherlands

Location

Related Publications (1)

• Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.

  PMID: 32065303 DERIVED

MeSH Terms

Interventions

BCG Vaccine; Vi polysaccharide vaccine, typhoid

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Mihai Netea, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

NL (1)