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BCG vaccine

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AJVaccines · 细胞治疗 · 细胞治疗

什么是 BCG vaccine？

BCG vaccine 是一种细胞治疗，由AJVaccines研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intradermal Injection。

药物档案

公司AJVaccines
药物类别细胞治疗, 疫苗
给药途径Injectable (Others), Intradermal Injection
状态Approved
来源： ClinicalTrials.gov, AJVaccines

相关研究文献

PubMedMicroorganisms2026-10-27

Research on the Regulatory Effects of Resveratrol on BCG-Induced Autophagy and Apoptosis in Macrophages via Targeting SIRT1.

Li Ruiqian R, Xie Yujie Y, Li Mingzhu M, Wan Wenhao W et al.

Mycobacterium tuberculosis (Mtb) infection can trigger immune responses in macrophages during its autophagy and apoptosis, as two crucial cellular processes which are essential for the host to clear the pathogen. Resveratrol (RES) is a natural polyphenolic compound with various biological functions such as anti-inflammatory, antioxidant, and immunomodulatory activities. However, the specific mechanism by which it regulates autophagy and apoptosis in a Bacillus Calmette-Guérin (BCG)-infected macrophage model remains to be elucidated. This study aimed to analyze the effects of RSE on BCG-induced autophagy and apoptosis in macrophages and explore the underlying molecular mechanisms. The mouse macrophage cell line RAW264.7 was used to establish a BCG infection model and evaluate the interventional effects of RES. Cell viability was detected by CCK-8 assay. The expression levels of autophagy- and apoptosis-related proteins were analyzed by Western blotting. LC3 puncta formation was observed by immunofluorescence. Autophagy rate and apoptosis rate were determined by flow cytometry. The ultrastructure of autophagosomes and autolysosomes was observed by transmission electron microscopy. The results showed that BCG infection significantly increased the expression of LC3-II, Beclin1, Atg5, and Atg7 in macrophages; decreased p62 levels; and increased the number of intracellular autophagosomes and autolysosomes. Concurrently, BCG infection also induced apoptosis, including upregulation of Bax, Caspase 3, Caspase 9, and PARP1 expression; downregulation of Bcl-2 expression; and an increased apoptosis rate. RES promoted autophagosome accumulation and inhibited apoptosis in BCG-infected macrophages in a concentration-dependent manner; however, these effects were significantly attenuated after SIRT1 gene silencing by siRNA and inhibition by EX527. Therefore, it is speculated that RES may regulate autophagy and apoptosis through the SIRT1/FOXO1 pathway. These findings provide a potential experimental basis for developing RES into a host-directed therapeutic (HDT) agent, and offer new insights into the mechanisms by which natural products participate in host defense.

PMID 42943603
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PubMedZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences2026-10-27

[Safety and humoral immune responses of an inactivated whole-cell lysate of Mycobacterium tuberculosis B/R fusion strain prepared by combined ultrasonic disruption and enzymatic digestion].

Pan Zhimin Z, Liu Zhixun Z, Liang Su S, Li Xiaomei X et al.

Tuberculosis remains the leading cause of death from a single infectious disease. Because currently available vaccines provide limited protection, the development of novel tuberculosis vaccines with favorable safety and high efficacy remains necessary. An inactivated whole-cell lysate of Mycobacterium tuberculosis B/R fusion strain prepared by combined ultrasonic disruption and enzymatic digestion (UK-B/R) retains key antigenic components while ensuring complete bacterial inactivation; however, its safety and immunogenicity have not been fully characterized. This study aims to evaluate the safety of UK-B/R and the humoral immune responses induced by UK-B/R. In the cell experiments, murine monocyte/macrophage leukemia RAW264.7 cells were divided into a blank control (control) group, a BCG group, a B/R group, and a UK-B/R group. After 24 h of treatment, the levels of interleukin-1β (IL-1β) and interleukin-6 (IL-6) in the cell culture supernatants were measured using enzyme-linked immunosorbent assay (ELISA), and the apoptotic rate was determined by flow cytometry. In the animal experiments, 6-8-week-old C57BL/6J mice were randomly assigned to the phosphate-buffered saline (PBS), BCG, B/R, and UK-B/R groups for acute and long-term toxicity studies. In the acute toxicity study, mice in each group received a single subcutaneous administration and were observed continuously for 14 days. General condition, changes in body weight, mortality, and other parameters were recorded. In the long-term toxicity study, mice in each group were immunized subcutaneously on days 0, 14, and 28. Serum and lung, liver, spleen, and kidney tissues were collected on day 3 (acute phase) and day 14 (recovery phase) after the final immunization. Organ indices were calculated, and levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin (ALB), serum creatinine (SCr), and blood urea nitrogen (BUN) were measured. Hematoxylin and eosin staining was performed to assess histopathological changes in major organs. In addition, 15 female C57BL/6J mice aged 6 to 8 weeks were randomly assigned to the PBS, BCG, and UK-B/R groups. On day 14 after the final subcutaneous immunization, antigen-specific antibody levels in serum and bronchoalveolar lavage fluid (BALF) were measured by ELISA. IL-1β and IL-6 levels in the cell culture supernatants were significantly higher in the UK-B/R group than in the control group (both P<0.05). IL-1β levels did not differ significantly between the UK-B/R group and either the BCG or B/R group (both P>0.05), whereas IL-6 levels were significantly lower in the UK-B/R group than in the BCG and B/R groups (both P<0.05). The apoptotic rate did not differ significantly between the UK-B/R and control groups (P>0.05). In the acute toxicity study, no abnormal reactions or deaths occurred in any group. Body weight showed an increasing trend in all groups, with no significant between-group differences (P>0.05). In the long-term toxicity study, no significant differences were observed among the groups in the organ indices of the lung, liver, spleen, and kidney or in ALT, AST, ALB, SCr, and BUN levels (all P>0.05). Histopathological examination revealed no obvious pathological changes in the lung, liver, spleen, or kidney tissues of mice in any group. Immunological evaluation showed that serum antigen-specific IgG antibody levels were significantly higher in the UK-B/R group than in the PBS and BCG groups. Antigen-specific IgG and IgA antibody levels in BALF were also significantly higher in the UK-B/R group than in the PBS and BCG groups (all P<0.05). UK-B/R demonstrated favorable safety profiles at both the cellular and animal levels and induced antigen-specific humoral and mucosal immune responses.

PMID 42935198
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PubMedAnimals : an open access journal from MDPI2026-10-27

An mRNA-LNP Vaccine Encoding the Erns-E1-E2 Polyprotein Confers Complete Protection Against Bovine Viral Diarrhea Virus in Mice.

Yue Zongzhe Z, Li Yanmin Y, Yang Hongjun H, Bian Shiao S et al.

Bovine viral diarrhea virus (BVDV) remains a major barrier to sustainable livestock development. Conventional BVDV vaccines are limited by inherent drawbacks such as potential virulence reversion and insufficient protective efficacy, which severely hamper global BVDV eradication efforts. mRNA vaccine technology, characterized by high expression efficiency, a favorable safety profile, and scalable manufacturing, offers a promising platform for next-generation BVDV vaccine development. In this study, we developed an mRNA-LNP vaccine candidate (Erns/E1/E2 vaccine) encoding the full-length structural glycoproteins Erns, E1 and E2, and systematically evaluated its immunogenicity and protective efficacy in BALB/c mice. The E2 extracellular domain-human IgG1 Fc fusion mRNA vaccine (E2/IgG1 vaccine) and a commercial inactivated BVDV vaccine served as controls. Our results demonstrated that the Erns/E1/E2 vaccine elicited significantly higher neutralizing antibody titers (log10NT50 = 2.50 ± 0.082) and lymphocyte proliferation responses (stimulation index = 6.927 ± 0.145) than both control vaccines at 28 days post-primary vaccination (two weeks post-booster). Notably, no viral RNA was detected in any tissue or blood samples from Erns/E1/E2-immunized mice at any time point following BVDV challenge, indicating complete immune protection against viral infection, whereas viral loads were consistently detected in multiple tissues of both control groups. These findings establish the Erns/E1/E2 vaccine as a highly promising BVDV vaccine candidate and provide critical experimental support for advancing mRNA-based BVDV vaccine development.

PMID 42939244
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PubMedAvian diseases2026-10-27

Spike Binding and Replication of Kidney-Cell-Adapted Infectious Bronchitis Virus in Chickens.

Saiada Farjana F, Zegpi Ramon A RA, Joiner Kellye S KS, Toro Haroldo H et al.

Viral subpopulations in Arkansas Delmarva Poultry Industry (ArkDPI)-derived IBV vaccines are rapidly selected in inoculated chickens, resulting in tracheal damage and virus persistence. These subpopulations with distinct spike (S) amino acid sequences were previously eliminated from an ArkDPI-derived vaccine strain during serial passage in chicken embryonic kidney (CEK) cells, and a new viral population with an S protein harboring three amino acid differences relative to the original vaccine major population became predominant. Recombinant S protein representing the CEK-adapted vaccine strain showed severely reduced or no detectable binding to CEK cells. The two amino acid substitutions in the S1 subunit and the single amino acid substitution in the S2 subunit independently reduced binding. Structural models predicted that each of the amino acid substitutions involved an amino acid located at the interface between monomers in the trimer, suggesting that the conformation and/or stability of alternative conformations of the trimer might be affected. Recombinant S protein representing the CEK-adapted virus also exhibited reduced or nondetectable binding to most relevant chicken tissues in vitro. We compared replication after ocular inoculation in 1-day-old chickens between our CEK-adapted ArkDPI virus and a commercial ArkDPI-derived vaccine. Viral replication in individual chickens was monitored by relative levels of viral RNA in tears 3, 5, and 8 days postvaccination (DPV) and in choanal and tracheal swabs 5 and 8 DPV, determined by reverse transcription quantitative polymerase chain reaction. At 3 DPV, tears of chickens inoculated with 105 50% embryo infectious doses (EID50) of CEK-adapted vaccine and 104 EID50 commercial ArkDPI vaccine had similar viral loads, while those of chickens given 104 EID50 CEK-adapted vaccine were two orders of magnitude lower. Viral loads in tears of both chicken groups given the CEK-adapted vaccine remained at levels similar to 3 DPV through days 5 and 8 DPV, while those in chickens given the commercial vaccine increased three orders of magnitude during the same period. Statistically significant differences among groups were also observed in viral loads in choanal and tracheal swabs at both 5 and 8 DPV, though less pronounced. The sharp increase in viral load in tears of chickens given the commercial vaccine was likely due to efficient replication of vaccine subpopulations selected in chickens, which are lacking in the CEK-adapted vaccine. Selection of vaccine subpopulations in chickens given the commercial vaccine, but not in chickens given the CEK-adapted vaccine, was verified by S1 gene sequencing of the IBV genomes in samples from individual chickens in all vaccinated groups. Protection following ocular challenge at 19 DPV with virulent Ark IBV, as assessed by reductions in viral loads in tears, correlated with vaccine viral loads at 5 and 8 DPV, with the greatest correlation (r = 0.52) with vaccine viral load in choanal swabs at 8 DPV.

PMID 42937671
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PubMedVeterinary sciences2026-10-27

Immunization Efficacy of a Commercialized Inactivated Mycoplasma bovis (Strain HM) Vaccine in Calves at a Large-Scale Dairy Farm in Yancheng, Jiangsu Province.

Li Yingjian Y, Zhang Ruihua R, Jin Yiquan Y, Wang Lei L et al.

Mycoplasma bovis (M. bovis)-positive clinical Bovine Respiratory Disease (BRD) seriously threatens the survival and growth of calves. Against the global backdrop of escalating antimicrobial resistance, effective vaccines represent a promising strategy for the prevention and control of M. bovis-positive clinical BRD. This study aimed to characterize the epidemiological features of BRD on a large-scale dairy farm in Yancheng, Jiangsu Province, and to assess the efficacy of an inactivated M. bovis strain HM vaccine using a randomized, double-blind, controlled field trial conducted during the high-incidence season. In total, 200 healthy 3-4-week-old Holstein calves seronegative for M. bovis-specific antibodies were randomly allocated to either a vaccine group or a control group. Calves in the vaccine group received two intramuscular vaccine doses on day 0 and day 14, while control calves received an equal volume of placebo at identical time points. The entire trial spanned 194 days. A comprehensive assessment was carried out, including vaccine tolerability, growth performance, serum antibody and cytokine profiles, BRD incidence, infection rates of common pathogens, and vaccine protective efficacy. The results showed that the farm-level annual BRD incidence was 9.27%, consistent with typical temporal-spatial-herd distribution patterns. Calves exhibited good tolerability after vaccination, and the vaccine had no adverse effect on body-weight gain. Importantly, vaccination markedly elevated serum specific antibody levels, seropositivity rates, and concentrations of inflammatory cytokines including IL-4, IL-6, and IL-10 (p < 0.05). Moreover, vaccination reduced the risk of M. bovis-positive clinical BRD by 61% and decreased infection risks for several respiratory pathogens. Collectively, this inactivated vaccine demonstrated satisfactory tolerability and protective effects, providing critical technical evidence for the prevention and control of M. bovis-positive clinical BRD in dairy farms.

PMID 42944122
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PubMedMicroorganisms2026-10-27

In Silico Design and Evaluation of a Multi-Epitope Vaccine Candidate Against Staphylococcus haemolyticus.

Almatroudi Ahmad A

S. haemolyticus is an emerging multidrug-resistant pathogen that frequently causes nosocomial infections, yet no licensed vaccine is currently available for its prevention. In this study, conserved surface-associated proteins were screened to identify B-cell, cytotoxic T-lymphocyte, and helper T-lymphocyte epitopes for the design of a multi-epitope vaccine candidate. The selected epitopes were assembled into a 254-amino acid construct containing human β-defensin-3, the PADRE sequence, and selected linkers. The resulting construct was predicted to be antigenic, non-allergenic, and non-toxic, with favorable physicochemical properties, structural stability, and solubility. The selected CTL and HTL epitopes provided an estimated global population coverage of 97.5%, indicating broad predicted coverage across different populations. Structural analysis supported the quality of the refined three-dimensional model. Molecular docking predicted favorable interactions between the vaccine construct and TLR2 and TLR4, while 200 ns molecular dynamics simulations indicated that receptor-vaccine interactions were maintained during the simulation period. Codon optimization and in silico cloning further supported the feasibility of recombinant expression in Escherichia coli. Overall, the computational analyses support the proposed multi-epitope construct as a potential vaccine candidate against S. haemolyticus and provide a basis for its further experimental evaluation.

PMID 42943392
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