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Bacillus Calmette-Guerin vaccine

✓ Approved

Verity Pharmaceuticals Inc · Cell-based Therapies · Cell-based Therapies

What is Bacillus Calmette-Guerin vaccine?

Bacillus Calmette-Guerin vaccine is a cell-based therapies developed by Verity Pharmaceuticals Inc. It is approved for therapeutic indications via injectable (others) or intravesical injection.

Drug Profile

CompanyVerity Pharmaceuticals Inc
Drug ClassCell-based Therapies, Vaccine
RouteInjectable (Others), Intravesical Injection
StatusApproved
Sources: ClinicalTrials.gov, Verity Pharmaceuticals Inc

Therapeutic Indications

Bacillus Calmette-Guerin vaccine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Neoplasms benign, malignant and unspecified (incl cysts and polyps)Bladder cancer✓ Approved

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PubMedCancer drug resistance (Alhambra, Calif.)2026-11-11

Extracellular vesicles as integrative hubs of drug resistance in bladder cancer.

Huang Cheng-Shuo CS, Yu Cheng-Ping CP, Yu Dah-Shyong DS, Wu Ying-Si YS et al.

Therapeutic resistance remains a major challenge in bladder cancer, encompassing resistance to intravesical Bacillus Calmette-Guérin (BCG) therapy, platinum- and gemcitabine-based chemotherapy and immune-checkpoint blockade. Although extracellular vesicles (EVs) have been implicated in cancer drug resistance, their roles in bladder cancer are often discussed within the broader context of EV biology, making it difficult to distinguish direct mechanisms of treatment resistance from treatment-associated remodelling or biomarker associations. In this review, we refocus EV-mediated therapeutic resistance in bladder cancer and propose an evidence-stratified framework, distinguishing EVs as causal mediators, permissive amplifiers or biomarkers of drug adaptation. Studies have provided substantial mechanistic evidence from chemotherapy-associated models, including EV-mediated regulation of gemcitabine resistance through H3C14-associated EV remodelling and chemotherapy-exposed bladder cancer EVs that support stem-like, treatment-tolerant tumour states. Evidence supporting EV involvement in platinum resistance, BCG failure and immunotherapy resistance remains biologically plausible but less directly established. Therefore, clearer drug-specific models, improved EV-subtype resolution, cargo perturbation and functional rescue experiments are needed. We also discuss urinary EVs for longitudinal monitoring of treatment response and emerging resistance in bladder cancer. By integrating drug-specific therapeutic contexts with EV-specific causality criteria, this review provides a focused framework for evaluating when EVs mediate bladder cancer drug resistance, amplify adaptive tumour-microenvironment states or primarily serve as biomarkers for therapeutic monitoring.

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PubMedFrontiers in oncology2026-11-11

Bladder cancer immune microenvironment: immune-cell distribution, disease associations, treatment remodeling, and baseline immune features associated with treatment response and prognosis.

Qin Shaobo S, Yu Xu X, Zuo Shishuai S, He Xiangfei X et al.

Bladder cancer is characterized by substantial heterogeneity in the tumor immune microenvironment (TIME), which influences recurrence, progression, treatment resistance, and responses to Bacillus Calmette-Guérin (BCG), neoadjuvant chemotherapy, immune checkpoint inhibitors, and radiotherapy. This narrative review critically synthesizes evidence on immune-cell distribution, disease-state associations, treatment-associated remodeling, and baseline immune features linked to treatment response and prognosis. Current evidence indicates that the clinical meaning of immune infiltration depends not only on cell abundance but also on localization across histological compartments, functional state, tumor compartment, and therapeutic context. Cytotoxic lymphocyte infiltration may indicate antitumor immune activity when tumor-accessible and functionally active, whereas regulatory T cells, myeloid-derived suppressor cells, and M2-like tumor-associated macrophages often reflect suppressive or treatment-resistant immune states. Treatments can reshape the bladder cancer TIME, but the strength of evidence varies across modalities: BCG has relatively stronger human support for treatment-associated immune changes, whereas evidence for chemotherapy-, immunotherapy-, and radiotherapy-associated remodeling remains more heterogeneous. Baseline or pretreatment immune architecture may provide a more informative basis for biomarker development than single immune-cell markers. Future longitudinal studies with matched pre- and post-treatment specimens are needed to determine whether treatment-induced TIME changes provide additional treatment-response-associated or prognostic information beyond baseline immune features, whereas establishment of predictive utility will require comparative treatment designs with formal biomarker-by-treatment interaction testing.

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PubMedMicrobiology resource announcements2026-11-11

Draft genome sequence of Bacillus stercoris B5-225 isolated from saline soil surrounding salt mines in the Northwestern Himalayas, India.

Rana Partiksha P, Badiyal Anila A, Bisht Nivedita N, Verma Shailender K SK et al.

We report the draft genome sequence of Bacillus stercoris strain B5-225, isolated from saline soil surrounding the salt mines of the Northwestern Himalayas, India. The draft genome comprises 3,958,477 bp in 41 contigs, with a GC content of 44.0%, an estimated completeness of 98.82%, and contamination of 0.02%.

PMID 43012416
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PubMedNPJ vaccines2026-11-11

A structure-guided trivalent subunit vaccine confers maternal protection to neonatal piglets against PEDV and PDCoV.

Liu Jia J, Chen Longping L, Li Dan D, Wang Zhuo Z et al.

Antigenic divergence among porcine epidemic diarrhea virus (PEDV) genotypes and porcine deltacoronavirus (PDCoV) limits the cross-protection provided by current commercial vaccines. Here, employing a structure-guided antigen design strategy, we developed a trivalent subunit vaccine concurrently targeting PEDV G2a, PEDV G2b, and PDCoV. The vaccine antigen set comprises optimized spike ectodomain antigens, featuring stabilizing mutations, a heptad repeat 2 (HR2) deletion, a fused neutralizing epitope, and a flagellin adjuvant fused to the N-terminus. Formulated with MF59+CpG adjuvants, this trivalent vaccine elicited robust PEDV- and PDCoV-specific neutralizing antibody responses and Th1/Th2-associated cellular immune responses characterized by IFN-γ, IL-2, and IL-4 production in mice. Immunization of pregnant sows with 300 μg dose induced high-titer IgG, IgA, and colostral secretory IgA (SIgA) against all three target viruses. Although neutralizing antibody titers were comparable between the 100 μg and 300 μg dose groups, the 300 μg group showed higher and more persistent levels of colostral binding IgG and SIgA. Following maternal immunization, piglets that acquired maternal antibodies through colostrum exhibited reduced clinical diarrhea, lower fecal viral RNA shedding, and less severe intestinal lesions after challenge with PEDV G2a, PEDV G2b, or PDCoV. These findings support this structure-guided trivalent subunit vaccine as a promising candidate for maternal immunization against co-circulating porcine enteric coronaviruses.

PMID 43009510
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PubMedNature microbiology2026-11-11

S-layer expansion is mediated by hoop-like cracks in the paracrystalline lattice during Bacillus anthracis growth.

Zhang Chen C, Yu Yuanchen Y, Yu Qiwei Q, Rudner David Z DZ

Surface layers (S-layers) are paracrystalline protein monolayers that envelop archaea and some bacteria, including Bacillus anthracis. S-layer subunits in B. anthracis are tethered to the underlying cell wall through glycopolymers that are covalently attached to the peptidoglycan (PG) meshwork. Cell growth in this rod-shaped organism occurs by dispersed PG synthesis throughout the cell cylinder. How the crystalline lattice expands in lockstep with the cell wall has remained unclear. Here, using fluorescently labelled S-layer subunits and high-resolution imaging, we show that S-layer expansion during B. anthracis growth is mediated by pervasive hoop-like cracks in the lattice. Pulse-chase experiments reveal two modes of S-layer assembly at these cracks: dispersed and focused. Our data suggest that local pulling forces on the S-layer array generated by dispersed cell wall synthesis and expansion of the underlying PG cause crack formation, with ensuing dispersed and focused synthesis enabling S-layer expansion with bacterial growth.

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PubMedHealth communication2026-11-11

Spiritual Health Locus of Control and COVID-19 Booster Intentions Among Hispanic Americans: A Culturally Grounded Extension of the Extended Parallel Process Model.

Kim Joon J, Jun Jungmi J, Zambrano Rodriguez Viviana Carolina VC

Declining uptake of COVID-19 boosters poses significant public health concerns. Hispanic Americans, who have experienced disproportionate pandemic impacts, report lower uptake of updated boosters than non-Hispanic White adults, partly attributable to vaccine hesitancy. Although religiosity plays a central role in Hispanic communities, little is known about how spiritually grounded beliefs shape cognitive and emotional responses to vaccination. This study integrates the extended parallel process model (EPPM) with spiritual health locus of control (SHLOC) to examine how exposure to faith-based and governmental vaccine information influences booster intention through spiritually grounded efficacy appraisals. Using an online survey of Hispanic American adults (N = 349), we tested a structural equation model linking SHLOC, perceived threat, efficacy beliefs, fear, and vaccination intentions. Results indicated that active SHLOC, reflecting beliefs in divine partnership in health, increased response efficacy and indirectly promoted booster intention and vaccine advocacy, whereas passive SHLOC, reflecting divine determinism, reduced self-efficacy and indirectly discouraged booster intention. Perceived threat was positively associated with fear, and efficacy beliefs emerged as the strongest predictors of booster intention. Mediation analyses supported serial pathways from message exposure to SHLOC to efficacy to intention, identifying spiritually grounded control beliefs as a culturally embedded mechanism in vaccine decision making. Findings suggest that faith-based engagement can function as either a protective or risk communication channel, depending on whether messages reinforce divine partnership or determinism. The study advances EPPM by identifying SHLOC as a culturally grounded antecedent to efficacy appraisal and offers implications for culturally responsive vaccine communication in Hispanic communities.

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