NCT03400878

Comparing Morbidity and Mortality Effects of Two Different Strains of BCG

Completed Phase 4 Last updated 16 December 2020

What this trial tests

Phase 4 trial testing BCG-Japan in Heterologous Immunity in 17,505 participants. Completed in 1 October 2020.

Timeline

14 October 2017

Primary endpoint
1 June 2020

1 October 2020

Quick facts

Lead sponsor	Bandim Health Project
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	17,505
Start date	14 October 2017
Primary completion	1 June 2020
Estimated completion	1 October 2020
Sites	2 locations across Guinea-Bissau

Drugs / interventions tested

• BCG-Japan — full drug profile →
• BCG-Russia — full drug profile →

Conditions studied

• Heterologous Immunity — all drugs for Heterologous Immunity →
• Infant Morbidity — all drugs for Infant Morbidity →
• Infant Mortality — all drugs for Infant Mortality →
• Trained Immunity — all drugs for Trained Immunity →

Sponsor

Bandim Health Project — full company profile →

Who can join

Under 42 Days, any sex, with Heterologous Immunity or Infant Morbidity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Parental Bacillus Calmette-Guérin vaccine scars decrease infant mortality in the first six weeks of life: A retrospective cohort study.
   Berendsen M, Schaltz-Buchholzer F, Bles P, Biering-Sørensen S, et al · · 2021 · cited 21× · PMID 34430834 · DOI 10.1016/j.eclinm.2021.101049
2. Effects of Neonatal BCG-Japan Versus BCG-Russia Vaccination on Overall Mortality and Morbidity: Randomized Controlled Trial From Guinea-Bissau (BCGSTRAIN II).
   Schaltz-Buchholzer F, Nielsen S, Sørensen MK, Stjernholm EB, et al · · 2024 · cited 4× · PMID 38500576 · DOI 10.1093/ofid/ofae057
3. Association of <i>Bacillus</i> Calmette Guerin Vaccine Strains with COVID-19 Morbidity and Mortality - Evaluation of Global Data.
   Chaudhari VL, Godbole CJ, Gandhe PP, Gogtay NJ, et al · · 2021 · cited 4× · PMID 35068744 · DOI 10.4103/ijcm.ijcm_103_21