ArticleiScience2026
Long-term stability of the GMP-compliant recombinant BCG vaccine against human RSV under quality control analyses.
Article in iScience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The human respiratory syncytial virus (RSV) is a leading cause of severe respiratory infections in newborns, young children, immunocompromised patients, and older adults. The current landscape of approaches to preventing the RSV disease includes vaccines for older adults and pregnant women, as well as prophylactic monoclonal antibodies for newborns and infants, with positive results. To expand the availability of prophylactic options against the RSV disease for vulnerable individuals, including newborns and older adults, we developed a recombinant BCG-based vaccine expressing the RSV nucleoprotein (rBCG-N-RSV) and manufactured under Good Manufacturing Practice (GMP) conditions. This vaccine has previously been shown to be safe and immunogenic in murine models, in neonatal calves, and has completed a phase 1 clinical trial in human adults. This article aims to assess the quality control testing of a GMP lot of rBCG-N-RSV to ensure antigen expression, potency, safety, and efficacy, which are required to advance to further clinical trials. Notably, all these parameters complied with release requirements. Furthermore, vaccine safety and protection were evaluated in a murine model of RSV infection, demonstrating enhanced virus-specific CD4
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