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Comparing Morbidity and Mortality Effects of Two Different Strains of BCG

NCT03400878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17505

Last updated 2020-12-16

No results posted yet for this study

Summary

Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (TB) is associated with reduced mortality in the first months of life.

BCG is a live attenuated vaccine, which means that it consists of active tuberculosis bacteria that are not capable of infecting a human with TB. BCG has been grown and maintained at many different laboratories all over the world using slightly different laboratory techniques. Due to the accumulation of genetic mutations in the different BCG strains, many variants of the vaccine exists today. These have different properties when it comes to immune response, side effects, protection against TB and scar formation. The BCG scar status after vaccination is a good marker for the non-specific effects of the vaccine; among BCG-vaccinated infants, those with a BCG scar have improved survival. The investigators hypothesize that the different types of BCG vary in terms of the strength of the non-specific effects and thus the impact on overall morbidity and mortality.

In the trial, the investigators will compare the two most widely used BCG strains in the world, BCG-Russia and BCG-Japan, with respect to their non-specific effects on morbidity and mortality. As an addition, the investigators will study the effect of maternal BCG vaccination on the subsequent effect of BCG-vaccination in the offspring, since there are indications that the maternal BCG scar status primes for a stronger non-specific response in the offspring.

Conditions

  • Heterologous Immunity
  • Infant Morbidity
  • Infant Mortality
  • Trained Immunity
  • Vaccine Reaction
  • Vaccine Adverse Reaction

Interventions

BIOLOGICAL

BCG-Japan

One dose of 0.05 ml BCG-Japan vaccine applied to the left deltoid region.

BIOLOGICAL

BCG-Russia

One dose of 0.05 ml BCG-Russia vaccine applied to the left deltoid region.

Sponsors & Collaborators

  • Research Center for Vitamins and Vaccines

    collaborator UNKNOWN

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, Professor · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
42 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-14
Primary Completion
2020-06-01
Completion
2020-10-01

Countries

  • Guinea-Bissau

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400878 on ClinicalTrials.gov