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botulism+tetanus vaccine

✓ Approved

Microgen · 疫苗 · 疫苗

什么是 botulism+tetanus vaccine？

botulism+tetanus vaccine 是一种疫苗，由Microgen研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Subcutaneous Injection。

药物档案

公司Microgen
药物类别疫苗
给药途径Injectable (Others), Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, Microgen

治疗适应症

botulism+tetanus vaccine 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsBotulism✓ Approved
Infections and infestationsTetanus✓ Approved

相关研究文献

PubMedFrontiers in public health2026-10-27

An age-structured mathematical model of tetanus epidemiology, immunity, and vaccination across the life course.

Hounsell Rachel A RA, Norman Jared J, Silal Sheetal P SP

Tetanus remains a significant public health concern despite substantial reductions in incidence and mortality following the widespread introduction of tetanus-toxoid-containing vaccines (TTCVs). Because immunity is acquired only through vaccination and wanes over time, the World Health Organization recommends three booster doses throughout childhood and adolescence in addition to the three-dose infant primary series. However, few mathematical models explicitly represent the cumulative, dose-dependent nature of tetanus immunity needed to evaluate alternative vaccination strategies. We developed a novel age-structured model of tetanus epidemiology, immunity, and vaccination to address this gap. We developed a deterministic compartmental model stratified by age, vaccination history, and immunity status. The model incorporates environmental exposure, neonatal and non-neonatal tetanus, routine infant vaccination, booster doses, maternal immunization, and waning immunity. Unlike previous tetanus models, each TTCV dose is represented explicitly, allowing protection, waning, and booster responses to vary according to vaccination history. Model parameters were informed by published literature and expert consultation. Sensitivity analyses were conducted using Latin hypercube sampling and partial rank correlation coefficients, and model outputs were compared with published seroprevalence studies. The model reproduced expected patterns of vaccine-derived immunity and waning described in the literature and generated population protection estimates consistent with seroprevalence data from settings with different vaccination schedules. Sensitivity analyses identified the duration of vaccine-derived protection as a primary source of uncertainty, with vaccine effectiveness also substantially influencing population immunity. The framework successfully captured heterogeneous immunity profiles by age and vaccination history and the cumulative effects of primary series, booster doses, and maternal vaccination. This model provides a novel framework for representing cumulative TTCV-derived immunity across the life course. By explicitly tracking dose-specific protection and waning, it enables the evaluation of booster-dose strategies and maternal immunization programs and provides a platform for informing evidence-based tetanus vaccination policy.

PMID 42935852
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PubMedLife (Basel, Switzerland)2026-10-27

Generalized Tetanus in a Four-Month-Old Labrador Retriever: Complete Recovery and One-Year Follow-Up in a Rare Canine Case.

Fernoagă Cristina C, Turbatu Raluca Mihaela RM, Neagu Alexandru Gabriel AG, Pavel Ruxandra R et al.

Tetanus is an infrequent, potentially fatal neurological disease in dogs, caused by tetanospasmin, the neurotoxin of Clostridium tetani, which reaches the central nervous system by retrograde axonal transport and blocks the release of the inhibitory neurotransmitters glycine and γ-aminobutyric acid. Dogs are comparatively resistant to the toxin, and canine reports remain scarce. This report describes generalized tetanus in a four-month-old, 13 kg male Labrador Retriever presented with an axillary wound sustained approximately one month earlier and neurological signs progressing over approximately seven days, from gait disturbance to generalized whole-body rigidity. On examination the dog showed trismus, risus sardonicus, cervical hyperextension, opisthotonos, third-eyelid protrusion, a sawhorse stance, hyperthermia and intermittent respiratory distress. The diagnosis was established clinically, following a structured neurological work-up and exclusion of the principal differentials, as confirmatory assays were unavailable. Total serum calcium was within the reference interval; serum creatine kinase was elevated; and venous blood-gas analysis indicated a mild, compensated metabolic acidosis. Management comprised metronidazole and clindamycin, equine tetanus antitoxin, diazepam, meloxicam and intensive nursing care in a low-stimulation environment. The dog improved from the first day of hospitalization and recovered without residual deficits, with no recurrence over one year of follow-up. The favorable outcome, in a young canine patient for which the literature would predict a guarded prognosis, is consistent with the absence of clinically detectable autonomic and cardiorespiratory dysfunction and with meticulous supportive care.

PMID 42942178
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PubMedPharmaceuticals (Basel, Switzerland)2026-10-27

Plant-Derived Monoclonal Antibody Against Botulinum Neurotoxin: Pharmacokinetic Evaluation in a Mouse Model.

Simsom Nipaporn N, Suwanchaikasem Pipob P, Rattanapisit Kaewta K, Phoolcharoen Waranyoo W et al.

Background: Botulism, caused by Clostridium botulinum neurotoxins (BoNT/A and B), is a life-threatening disorder requiring rapid, effective therapeutic intervention. Plant-produced monoclonal antibodies offer a scalable alternative to conventional antibody manufacturing. This study evaluated the pharmacokinetic properties of 1B18 monoclonal antibody (mAb), transiently expressed in and extracted from tobacco (Nicotiana benthamiana), which binds both BoNT/A and BoNT/B with high affinity. Methods: Male ICR mice (n = 12/group) received intravenous or intramuscular doses of plant-produced 1B18 mAb (25-100 µg), with serum samples collected across pre-dose and 13 post-administration timepoints (totaling 14 timepoints). Antibody quantification was performed using ELISA and LC-MS/MS to assess consistency and reliability. Results and Discussion: Following intravenous administration, the mAb exhibited prolonged elimination with half-lives ranging from 40.4 to 56.0 h (at 25 and 50 µg doses). ELISA-derived absolute bioavailability was approximately 99% and 85% at the 50 and 100 µg intramuscular doses, demonstrating efficient systemic absorption comparable to intravenous administration. ELISA was used as the primary quantitative method for pharmacokinetic evaluation, whereas LC-MS/MS provided exploratory, sequence-specific support for the observed concentration-time profiles. Because many LC-MS/MS-derived concentrations were below the mathematically estimated LOQ, cross-platform comparisons were interpreted cautiously and were not considered evidence of analytical equivalence or interchangeability. Conclusions: These findings demonstrate that plant-derived 1B18 mAbs possess favorable pharmacokinetic profiles and high bioavailability, supporting their potential as long-acting therapeutic candidates for botulism treatment and advancing sustainable antibody production strategies.

PMID 42943294
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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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