BCG-PRIME

This is a randomized, controlled, multicenter trial that included 6112 immunologically vulnerable individuals aged over 60.

From the first inclusion to the end of their follow-up, the study took place in a period between September 2020 to June 2021. Participants were randomized 1:1 to receive either placebo or BCG vccination. Participants were asked to answer questions about infection symptoms, SARS-CoV-2 tests, vaccinations, and healthcare visits either via a smartphone application or via regular telephone calls for 6 months after intervention.

In this cohort, the available data are as follows:

• – Demographics and health-data
• – DNA methylation (from a subgroup, baseline only)
• – Cytokine production upon incubation with various viral, fungal and bacterial stimuli
• – Proteomics
• – Immunophenotyping

*The trial was approved by the Utrecht Institutional Review Board (protocol NL74730.041.20) and registered in the European Clinical Trials Database (2020-003470-47) and in clinicaltrials.gov (NCT04537663).

Selected Publications

Liu, Z., Ziogas, A., Zhang, Y., Gupta, M. K., Föhse, K., Taks, E., Dulfer, E., Sarlea, A., Ventriglia, L., Geckin, B., Ballan, M., van Unen, N., Helder, L., Trittel, S., Riese, P., Moorlag, S., de Bree, C., Koeken, V., Mourits, V., Jaeger, M., … Netea, M. G. (2026). Interferon-related inflammaging links epigenetic age acceleration to multimorbidity., Cell genomics, 6(6), 101218. https://doi.org/10.1016/j.xgen.2026.101218

Koekenbier, E. L., Fohse, K., van de Maat, J. S., Oosterheert, J. J., van Nieuwkoop, C., Hoogerwerf, J. J., Grobusch, M. P., van den Bosch, M. A. A. J., van de Wijgert, J. H. H., Netea, M. G., Rosendaal, F. R., Bonten, M. J. M., Werkhoven, C. H. H. V., & BCG-PRIME study group (2023). Bacillus Calmette-Guérin vaccine for prevention of COVID-19 and other respiratory tract infections in older adults with comorbidities: a randomized controlled trial. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases, 29(6), 781–788. https://doi.org/10.1016/j.cmi.2023.01.019