Role of BCG as Booster Vaccination

Radboud University Medical Center

Status: Completed

Conditions: BCG Vaccination

Treatments: Biological: TFV; Biological: BCG

Study type: Interventional

Funder types: Other

Identifiers

NCT02175420

BCG-TFV1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

TFV alone

Active Comparator group

Description:

Typhim Vi

Treatment:

Biological: TFV

BCG+TFV

Experimental group

Description:

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

Treatment:

Biological: BCG

Biological: TFV