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BC

BCG vaccine

✓ Approved

AJVaccines · Cell-based Therapies · Cell-based Therapies

What is BCG vaccine?

BCG vaccine is a cell-based therapies developed by AJVaccines. It is approved for therapeutic indications via injectable (others) or intradermal injection.

Drug Profile

CompanyAJVaccines
Drug ClassCell-based Therapies, Vaccine
RouteInjectable (Others), Intradermal Injection
StatusApproved
Sources: ClinicalTrials.gov, AJVaccines

Related Research Articles

PubMedTransboundary and emerging diseases2026-10-16

Monoclonal Antibodies Targeting Bacillus Calmette-Guérin (BCG) Outer Membrane Proteins Confer Protection Against Tuberculosis.

Li Huoming H, Jiang Yanyan Y, Shi Chenxi C, Zuo You Y et al.

Tuberculosis (TB), caused by the Mycobacterium tuberculosis complex (MTBC), is a persistent global health crisis, remaining the world's leading infectious killer. There were abundant outer membrane proteins (OMPs) distributed in the bacterial cell wall, while fewer proteins were identified and characterized as antigens that could induce protective antibodies against TB. The OMPs of BCG were extracted with the detergent N-octyl-β-D-glucopyranoside, and the extracted proteins were used to immunize mice to generate an antibody library. Subsequently, the library underwent HAT/HT screening, and five specific monoclonal antibodies (mAbs) targeting OMPs with higher titers named 9C5, 14E9, 9F6, 7B10, and 6F4 were obtained. Among the five mAbs, 9C5, 14E9, and 9F6 could increase macrophage phagocytosis, inhibit the mycobacteria growth in peripheral blood mononuclear cells (PBMCs), and enhance the fusion of phagosomes and lysosomes in macrophages. Mice were immunized with the three antibodies before being challenged with M. bovis, among which two antibodies, 14E9 and 9C5, exhibited a preventive effect against TB infection. Furthermore, antibody 9C5 also showed a therapeutic effect, characterized by significant decreases in lung burden and ameliorated lung lesions. The antigens targeted by the two antibodies 9C5 and 14E9 were identified by coimmunoprecipitation (co-IP) combined with mass spectrometry (MS), and the results demonstrated that antibodies 9C5 and 14E9 recognize BCG_2760c and MPB83, respectively. This research promotes a better understanding of host protective humoral immunity by BCG vaccination and the roles of antibodies in TB vaccine design and development.

PMID 42885427
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PubMedNature reviews. Urology2026-10-16

Combination therapy for BCG-unresponsive non-muscle-invasive bladder cancer: biological rationale and ongoing clinical strategies.

Daneshmand Siamak S, Boorjian Stephen A SA, Meeks Joshua J JJ, Lotan Yair Y et al.

Radical cystectomy is the current first-line treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer; however, this surgical procedure is associated with considerable morbidity and mortality. Bladder-preserving treatments, including single agents - such as nadofaragene firadenovec, a nonreplicating adenoviral-vector-based gene therapy; pembrolizumab, an immune checkpoint inhibitor immunotherapy; and single-agent intravesical chemotherapy using valrubicin or controlled-release gemcitabine - and combination therapies, including nogapendekin alfa inbakicept-pmln (an IL-15 receptor agonist immunotherapy) plus BCG - and multiagent intravesical chemotherapy (for example, gemcitabine plus docetaxel) are also recommended by current guidelines. Single-agent therapies can lead to development of acquired immune resistance; thus, combination therapies are a key area of interest for improving patient outcomes. Options for this approach include combinations of intravesical chemotherapy, BCG, immunotherapy, gene therapy and radiotherapy. These bladder-preserving combination therapies have the potential to change the treatment paradigm for patients with BCG-unresponsive non-muscle-invasive bladder cancer by improving clinical efficacy and avoiding the need for cystectomy. Future studies must evaluate the benefits and risks associated with combination treatment, considering patient convenience, toxicity, efficacy, the risk of progression and treatment cost.

PMID 42881230
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PubMedJournal of clinical medicine2026-10-16

Does Timing Matter? Perioperative Outcomes and Quality of Life After Early Versus Delayed Radical Cystectomy Following BCG Therapy.

Volz Yannic Y, Ghali Verena V, Pyrgidis Nikolaos N, Fabritius Matthias P MP et al.

Objectives: To determine whether the timing of radical cystectomy (RC), either early versus delayed following BCG therapy, affects perioperative outcomes and health-related quality of life (HRQOL) in patients with very-high-risk non-muscle invasive bladder cancer (NMIBC). While existing data focus on oncological endpoints, the impact of BCG on these outcomes remains unevaluated. Methods: We retrospectively analysed a prospectively maintained database of 126 patients undergoing RC for very-high-risk NMIBC at a tertiary referral centre, stratified into early RC (n = 81) and delayed RC (n = 45, following BCG therapy). Perioperative outcomes, HRQOL assessed by EORTC-QLQ-C30 at baseline and 3, 12, and 24 months postoperative, and overall survival (OS) were compared. Longitudinal HRQOL changes were analysed using linear mixed-effects models adjusted for age and Carcinoma in situ (CIS) status, correcting for multiple comparisons. Results: Groups were well-balanced at baseline regarding age, sex, BMI, and ECOG performance status. No significant between-group differences were observed in overall complication rates, hospital stay length, or any QLQ-C30 domain at any timepoint, including global health status (GHS), in linear mixed-effects models accounting for repeated measures and multiple comparisons. OS did not differ between groups (p = 0.720). Conclusions: Prior BCG therapy does not adversely influence perioperative outcomes or HRQOL following RC for very-high-risk NMIBC. These findings support the initial use of BCG in eligible patients, as a trial of intravesical therapy does not appear to compromise surgical safety or postoperative quality of life when cystectomy is ultimately required.

PMID 42881948
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PubMedImmunology2026-10-16

Epigenetic and Metabolic Changes That Drive Trained Immunity in Response to Microbes and Vaccines.

Abebaw Desalegn D, Atnaf Aytenew A, Tegegne Bantayehu Addis BA, Fenta Abebe A et al.

Trained immunity is a form of innate immune memory in which initial exposure to microbial components or vaccines leads to long-lasting functional reprogramming of innate immune cells through epigenetic and metabolic changes. Unlike adaptive immunity, it does not rely on B or T lymphocytes and provides broad, nonspecific protection against various pathogens. This phenomenon has been observed across a range of immune cells, including monocytes, macrophages, neutrophils, NK cells and even γδ T-cells, as well as at the level of haematopoietic stem and progenitor cells (HSPCs). Key inducers include microbial products (e.g., β-glucan, BCG and MMR vaccines), metabolic byproducts (e.g., mevalonate and lactate) and cytokines such as IL-1β. These agents activate signalling pathways such as the Akt/mTOR/HIF-1α pathway and lead to chromatin remodelling via histone modifications such as H3K4me3 and H3K9me3. Immunometabolism plays a pivotal role, with trained cells shifting toward glycolysis, glutaminolysis and cholesterol synthesis. Lactate and fumarate further link metabolism to epigenetic remodelling. Notably, trained immunity can be protective in infectious diseases and beneficial in noninfectious contexts, such as cancer immunotherapy and autoimmune regulation. This review provides a comprehensive overview of the cellular, epigenetic and metabolic mechanisms underlying trained immunity, highlighting how innate immune cells acquire memory-like properties independent of adaptive immunity. This study also provides insights into the therapeutic potential of leveraging trained immunity for vaccine development, infection control and immunomodulation in noninfectious diseases.

PMID 42885325
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PubMedInternational journal of molecular sciences2026-10-16

Immune Profiles Elicited by Different HBV Vaccine Modalities and Their Associations with Serological and Intrahepatic Viral Outcomes.

Xiao Huiying H, He Jinhang J, Zhu Lili L, Wang Songmei S et al.

Therapeutic vaccination for chronic hepatitis B aims to restore HBV-specific T-cell immunity and contribute to a functional cure. We systematically compared the immune profiles and antiviral efficacy of four vaccine modalities: recombinant HBsAg (rHBsAg), antigen-antibody immune complex (IC), a DNA vaccine encoding HBsAg (DNA-HBsAg), and an HBsAg-Fc fusion DNA vaccine (DNA-HBsAg-Fc). In naïve mice, the rHBsAg vaccine predominantly induced anti-HBs IgG responses, whereas the IC vaccine elicited strong anti-HBs IgG and detectable CD4+ T-cell responses. In contrast, DNA vaccines preferentially induced HBsAg-specific CD8+ T-cell immunity, which was further enhanced by fusion to the Fc fragment of human IgG1. In the pre-immunization/AAV-HBV model, high anti-HBs titers in rHBsAg and IC groups were associated with rapid clearance of circulating HBsAg but not with comparable reductions in HBcAg+ hepatocytes, whereas stronger HBsAg-specific CD8+ T-cell responses in the DNA vaccine groups were associated with greater reductions in HBcAg+ hepatocytes. However, in the therapeutic AAV-HBV model, all vaccine monotherapies showed limited and non-sustained antiviral efficacy, with only transient reductions in serum HBsAg and limited reductions in HBcAg+ hepatocytes. These findings highlight the distinct immune profiles of different vaccine platforms and an association between stronger HBsAg-specific CD8+ T-cell responses and reduced intrahepatic HBcAg expression, while underscoring the limited efficacy of vaccine monotherapy in the AAV-HBV model.

PMID 42883747
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PubMedMilitary medicine2026-10-16

The Case for Dedicated Vaccine Communication Training: A Survey of Military Pediatricians.

Auvil Daley D, Jones Katherine K, Ratusnik Rebecca R, Adams Daniel J DJ

Vaccine uncertainty is rising among families in the United States, even among military families. The ACGME mandates that pediatric residents be trained in effective communication strategies for patients and families hesitant about recommended vaccinations, yet few validated curriculum tools exist. We aimed to understand the current landscape of vaccine uncertainty experienced by military general pediatricians and see what communication strategies were routinely being implemented in clinical practice. In March 2025, 45 graduates of a mid-sized military pediatrics residency program from the years 2016-2024 who were currently practicing general pediatricians were invited to participate in a survey on vaccine communication in clinical practice. The survey was a mix of quantitative questions asking for experienced trends in vaccine uncertainty as well as open-ended questions about communication strategies being implemented. Three clinical researchers performed a manual thematic analysis of free-text answers to understand and quantify common themes. Thirty-seven general pediatricians (82%) responded, and 95% of those surveyed rated a curriculum during medical training on vaccine communication as "very" or "extremely important." Only 19% of physicians were able to recall formal training in addressing vaccine hesitancy during medical school, and only 62% during residency. The 3 most commonly declined vaccines were COVID-19, influenza, and HPV. Pediatricians reported using communication strategies focused on knowledge-sharing (65%), partnership with families (62%), and normalizing vaccines (40%). Common barriers to vaccine acceptance were mistrust and disinterest, most commonly with unwillingness to engage in a conversation. Most practicing military pediatricians who graduated from our residency program report a rise in vaccine uncertainty in their practice and agree that a residency curriculum on vaccine communication is highly important. Such curricula should encourage evidence-based communication styles using vaccine normalization while de-emphasizing the urge to combat misinformation using knowledge-sharing and should specifically address the most commonly declined immunizations.

PMID 42885154
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