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Showing papers on "Anthrax vaccines published in 2020"


Journal ArticleDOI
TL;DR: The findings support FUC-HTCC NPs as a potential adjuvant of AVA for rapid induction of protective immunity and combine with AVA significantly increases the magnitude of IgG-anti-protective antigen titers in A/J mice.

28 citations


Journal ArticleDOI
TL;DR: The spectrum of disease caused by anthrax and the various prevention and treatment options are described and the current landscape of next-generation product candidates under development is discussed.
Abstract: Bacillus anthracis has been identified as a potential military and bioterror agent as it is relatively simple to produce, with spores that are highly resilient to degradation in the environment and easily dispersed. These characteristics are important in describing how anthrax could be used as a weapon, but they are also important in understanding and determining appropriate prevention and treatment of anthrax disease. Today, anthrax disease is primarily enzootic and found mostly in the developing world, where it is still associated with considerable mortality and morbidity in humans and livestock. This review article describes the spectrum of disease caused by anthrax and the various prevention and treatment options. Specifically we discuss the following; (1) clinical manifestations of anthrax disease (cutaneous, gastrointestinal, inhalational and intravenous-associated); (2) immunology of the disease; (3) an overview of animal models used in research; (4) the current World Health Organization and U.S. Government guidelines for investigation, management, and prophylaxis; (5) unique regulatory approaches to licensure and approval of anthrax medical countermeasures; (6) the history of vaccination and pre-exposure prophylaxis; (7) post-exposure prophylaxis and disease management; (8) treatment of symptomatic disease through the use of antibiotics and hyperimmune or monoclonal antibody-based antitoxin therapies; and (9) the current landscape of next-generation product candidates under development.

23 citations


Journal ArticleDOI
TL;DR: In vivo studies on A/J mice showed that (+)-FUC-TMC-NPs carrying AVA triggered an efficient response with a higher IgG anti-PA antibody titer than AVA with CpG oligodeoxynucleotides, and yielded 100 % protection when challenged with the anthracis spores.

19 citations


Journal ArticleDOI
29 Apr 2020
TL;DR: A robust pipeline of candidate vaccines are still in development to try to address some of the key research gaps in the anthrax vaccine field, focusing on those lead candidates in clinical development.
Abstract: A licensed anthrax vaccine has been available for pre-exposure prophylaxis in the United States since 1970, and it was approved for use as a post-exposure prophylaxis, in combination with antibiotic treatment, in 2015. A variety of other vaccines are available in other nations, approved under various regulatory frameworks. However, investments in anthrax vaccines continue due to the severity of the threat posed by this bacterium, as both a naturally occurring pathogen and the potential for use as a bioweapon. In this review, we will capture the current landscape of anthrax vaccine development, focusing on those lead candidates in clinical development. Although approved products are available, a robust pipeline of candidate vaccines are still in development to try to address some of the key research gaps in the anthrax vaccine field. We will then highlight some of the most pressing needs in terms of anthrax vaccine research.

13 citations


Journal ArticleDOI
TL;DR: PCP-I with or without CpG could significantly improve the survival rate of immunized mice following challenge with the anthrax lethal toxin, suggesting that PCP- I may be a promising vaccine adjuvant that warrants further study.
Abstract: Polysaccharides isolated from natural plants may represent a novel source of vaccine adjuvants. In this research, we focused on a natural plant polysaccharide, PCP-I, which is derived from Poria cocos, a Chinese traditional herbal medicine. We chose the anthrax protective antigen (PA) as a model to evaluate the adjuvant ability of PCP-I in enhancing the immunogenicity and protection of a PA-based anthrax vaccine. According to our results, PCP-I could significantly enhance anthrax specific anti-PA antibodies, toxin-neutralizing antibodies, anti-PA antibody affinity, as well as IgG1 and IgG2a levels. Besides, PCP-I increased the frequency of PA-specific memory B cells, increased the proliferation of PA-specific splenocytes, significantly stimulated the secretion of IL-4, and enhanced the activation of Dendritic cells (DCs) in vitro. The combination of PCP-I and CpG significantly enhanced the level of anti-PA antibodies and neutralizing antibodies, particularly PA-specific IgG2a, and shifted the Th2-bias to a Th1/Th2 balanced response. In addition, PCP-I with or without CpG could significantly improve the survival rate of immunized mice following challenge with the anthrax lethal toxin. These findings suggest that PCP-I may be a promising vaccine adjuvant that warrants further study.

12 citations


Journal ArticleDOI
TL;DR: Abstract Communicated by Ramaswamy H. Sarma is a post-graduate student of electrical engineering at the University of California, Berkeley and a member of the faculty at the California Institute of Technology, Berkeley.
Abstract: Abstract Communicated by Ramaswamy H. Sarma

10 citations


Journal ArticleDOI
TL;DR: Analysis of a vaccine formulation consisting of recombinant proteins from a surface-localized heme transport system containing near-iron transporter (NEAT) domains and its efficacy as a vaccine for anthrax disease provides evidence that a vaccine based upon recombinant NEAT proteins should be considered in the development of a next-generation anthrax vaccine.
Abstract: Bacillus anthracis is the causative agent of anthrax disease, presents with high mortality, and has been at the center of bioweapon efforts. The only currently U.S. FDA-approved vaccine to prevent anthrax in humans is anthrax vaccine adsorbed (AVA), which is protective in several animal models and induces neutralizing antibodies against protective antigen (PA), the cell-binding component of anthrax toxin. However, AVA requires a five-course regimen to induce immunity, along with an annual booster, and is composed of undefined culture supernatants from a PA-secreting strain. In addition, it appears to be ineffective against strains that lack anthrax toxin. Here, we investigated a vaccine formulation consisting of recombinant proteins from a surface-localized heme transport system containing near-iron transporter (NEAT) domains and its efficacy as a vaccine for anthrax disease. The cocktail of five NEAT domains was protective against a lethal challenge of inhaled bacillus spores at 3 and 28 weeks after vaccination. The reduction of the formulation to three NEATs (IsdX1, IsdX2, and Bslk) was as effective as a five-NEAT domain cocktail. The adjuvant alum, approved for use in humans, was as protective as Freund's Adjuvant, and protective vaccination correlated with increased anti-NEAT antibody reactivity and reduced bacterial levels in organs. Finally, the passive transfer of anti-NEAT antisera reduced mortality and disease severity, suggesting the protective component is comprised of antibodies. Collectively, these results provide evidence that a vaccine based upon recombinant NEAT proteins should be considered in the development of a next-generation anthrax vaccine.

9 citations


Journal ArticleDOI
30 Jun 2020
TL;DR: It was found that, when added in N2A cultures, PA63 toxin led to decreased cell spreading and cell aggregation, leading to apoptosis, which was substantially reduced by the concomitant addition of specific antibodies against PA63.
Abstract: Protective antigen (PA) 63 (PA63) is a protein derived from the PA83 component contained in the anthrax vaccine. The anthrax vaccine ("Biothrax") was administered together with other vaccines to Gulf War veterans, about 35% of whom later developed a multisymptom disease (Gulf War Illness [GWI]), with prominent neurological/cognitive/mood symptoms, among others. The disease has been traditionally attributed to exposures to toxic chemicals during the war but other factors could be involved, including vaccines received. Of these, the anthrax vaccine is the most toxic. Here, we assessed directly the PA63 toxin's harmful effects on cultured neuroblastoma 2A (N2A) cells with respect to cell spreading, process formation, apoptosis, and integrity of cell membrane, cytoskeleton, and mitochondria. We found that, when added in N2A cultures, PA63 toxin led to decreased cell spreading and cell aggregation, leading to apoptosis. The mechanisms of PA63-induced cell damage included compromised cell membrane permeability indicated by enhanced access of propidium iodide in cells. In addition, signaling pathways leading to organization of N2A cytoskeleton were negatively affected, as both actin and microtubular networks were compromised. Finally, the mitochondrial membrane potential was impaired in specific assays. Altogether, these alterations led to apoptosis as a collective toxic effect of PA63 which was substantially reduced by the concomitant addition of specific antibodies against PA63.

8 citations


Journal ArticleDOI
28 Oct 2020-Vaccine
TL;DR: The immunogenicity data suggest that the CpG adjuvant in the AV7909 vaccine helps to elicit a more robust immune response in subjects over the age of 65.

5 citations


Journal ArticleDOI
11 Feb 2020-Vaccine
TL;DR: The result suggest that GC1109 is protective against exposure to B. anthracis and the TNA titer of vaccinated serum can be an indicator for protective efficacy.

4 citations


Journal ArticleDOI
TL;DR: There is a knowledge gap about anthrax among the people in the affected communities, which could imply a high risk of outbreak of anthrax in Arua and Ugandan agricultural communities where the public health programs are less standardized and less effective.
Abstract: Background Anthrax is globally recognized as an important public health and economic challenge in many agricultural communities. A cross-sectional study was conducted in three subcounties in Arua district to assess the community's awareness, cultural norm, and practices regarding anthrax. This followed a report of active cases of human cutaneous anthrax in the district. Methods The study was conducted in subcounties of Pawor, Rigbo, and Rhino Camp, Arua district, using focus group discussion. Results The affected communities had limited knowledge about anthrax, especially its clinical manifestation and modes of transmission both in humans and animals. The community also had no knowledge of the anthrax vaccine or treatment and where they can be accessed from. Poor practices associated with anthrax outbreaks included poor disposal of carcasses and ruminal wastes, occupational hazards (butchers, slaughter men, and herdsmen), consumption of meat from infected animals, communal herding, and cultural norms encouraging consumption of dead animals. Conclusion This study shows that there is a knowledge gap about anthrax among the people in the affected communities. Key drivers for the anthrax outbreak such as poor cultural beliefs and practices and wildlife-livestock-human interactions were observed in all the three subcounties studied. All these findings could imply a high risk of outbreak of anthrax in Arua and Ugandan agricultural communities where the public health programs are less standardized and less effective.

Journal ArticleDOI
28 Feb 2020-Vaccine
TL;DR: Results suggest that the developed model can be useful in demonstrating added value of the vaccine for PEP, and post-exposure vaccination with the AV7909 anthrax vaccine candidate administered in combination with the partially curative ciprofloxacin treatment significantly increased survival of guinea pigs compared to ciprafloxACin treatment alone.


Journal ArticleDOI
TL;DR: A new case of anthrax vaccineeinduced nodules is reported, which demonstrates a reactive granular histiocytosis pattern, and Dermatologists and dermatopathologists should be cognizant of this entity and reaction pattern, especially in those lesions occurring in anatomic locations prone to receiving vaccinations.
Abstract: LCH: Langerhans cell histiocytosis SEM/EDX: scanning electron microscopy with energy dispersive x-ray spectroscopy INTRODUCTION Injection site granulomas secondary to aluminumcontaining vaccinations are a well-known, but rare phenomenon. Most previously reported cases were attributed to the influenza and tetanus vaccines. Clinical and histologic manifestation often mimics that of a neoplastic process, resulting in a diagnostic challenge for the dermatologist and dermatopathologist. Here we report a new case of anthrax vaccineeinduced nodules, which demonstrates a reactive granular histiocytosis pattern. Predominance of aluminum in the biopsy specimen, via scanning electron microscopy with energy dispersive x-ray spectroscopy (SEM/EDX) or ammonium aurin-tricarboxylate stain, can help rule out Langerhans cell histiocytosis (LCH) and cutaneous pseudolymphomas. Dermatologists and dermatopathologists should be cognizant of this entity and reaction pattern, especially in those lesions occurring in anatomic locations prone to receiving vaccinations to avoid mistaking it for a neoplastic process.

Journal ArticleDOI
TL;DR: In this study, development of a safe and ideal next‐generation subunit anthrax vaccine has been evaluated in mouse model.
Abstract: AIM Category A classified Bacillus anthracis is highly fatal pathogen that causes anthrax and creates challenges for global security and public health. In this study, development of a safe and ideal next-generation subunit anthrax vaccine has been evaluated in mouse model. METHOD AND RESULTS Protective antigen (PA) and BA3338, a surface layer homology (SLH) domain possessing protein were cloned, expressed in heterologous system and purified by IMAC. Recombinant PA and BA3338 with alum were administered in mouse alone or in combination. The humoral and cell-mediated immune response was measured by ELISA and vaccinated animals were challenged with B. anthracis spores via intraperitoneal route. The circulating IgG antibody titre of anti-PA and anti-BA3338 was found significantly high in the first and second booster sera. A significant enhanced level of IL-4, IFN-γ and IL-12 was observed in antigens stimulated supernatant of splenocytes of PA + BA3338 vaccinated animals. A combination of PA and BA3338 provided 80% protection against 20 LD50 lethal dose of B. anthracis spores. CONCLUSION Both antigens induced admirable humoral and cellular immune response as well as protective efficacy against B. anthracis spores. SIGNIFICANCE AND IMPACT OF THE STUDY This study has been evaluated for the first time using BA3338 as a vaccine candidate alone or in combination with well-known anthrax vaccine candidate PA. The findings of this study demonstrated that BA3338 could be a co-vaccine candidate for development of dual subunit vaccine against anthrax.

Journal ArticleDOI
TL;DR: In this paper, the Sterne strain F-34 vaccine has been used in ruminants for more than five decades in Bangladesh but there is little work describing the efficacy of the vaccine.
Abstract: Anthrax is a fatal disease that strike almost all warm-blooded animals and caused by a gram-positive bacterium Bacillus anthracis The disease is common in farm ruminants, causes regular mortality The disease is commonly prevented by using vaccine The Sterne strain F-34 vaccine has been using in ruminants for more than five decades in Bangladesh but there is little work describing the efficacy of the vaccine This study was aimed to evaluate efficacy of F-34 Sterne strain Anthrax vaccine in mice model Anthrax vaccine vials containing F-34 Stern strain was obtained from Central Disease Investigation Laboratory (CDIL), Dhaka and used in immunization trial A virulent field isolate was grown on PLET agar medium was used in protective efficacy trails Group C (n=05) and D (n=05) female mice were immunized subcutaneously with 01ml of anthrax vaccine Group A (n=05) and B (n=05) mice were served as non-immunized control Following 6 months of immunization the Group B (n=05) and Group D (n=05) mice were challenged intraperitoneally with 2x105 colony forming unit (CFU) of virulent field isolate of B anthracis Polymerase chain reaction (PCR) technique was carried out to detect pX01 (210bp) and pX02 gene (1035bp) specific PA and Cap genes of B anthracis from the challenged mice and field isolates The vaccine efficacy was evaluated in terms of anti-anthrax IgG antibodies responses in ELISA (A450±SD) and protection to challenge in vivo The early anti-anthrax IgG antibody response was detected in Group C and D mice (0501±0167) following week 2 of immunization and reached its peak in study week 4 (1237±0257) A steadily higher level of anti-anthrax IgG antibody response was detected until the end of study (06 months, 1269±0217, group average±SD) In vivo challenge to vaccinated mice with the virulent B anthracis found to confer solid protection up to six months of immunization Non-immunized mice challenged with field isolate of B anthracis were died within 18-24hours of infection, showed characteristics lesions of anthrax including black berry jam spleen, wide spread congestion and hemorrhages and bleeding through natural opening after death B anthracis bacteria was re-isolated from the visceral organs of infected mice This study provide evidence that the Sterne strain F-34 Anthrax vaccine is protective in mice model and generated higher level of anti-anthrax IgG antibody response that was detected until 06 months of immunization It needs to study whether the vaccine response persisted higher and longer in mice model and replicate the experiment in ruminants

Journal ArticleDOI
TL;DR: The Anti- PA4 ELISA was developed and the validation studies to evaluate the response of the antibody to the Anthrax vaccine and distinction between disease and vaccination in mice are conducted.
Abstract: Subunit vaccines or attenuated vaccines applied against Anthrax disease increase the immune systems' antibody against the PA4 which has a critical role as a toxin of Bacillus anthracis . The cornerstone of a vaccine showing its protection and efficacy in curbing the disease is the power of antibody applied against the PA4 however determination of the subjects’ exposure to the microbe or vaccine is not possible with the available Elisa kits. Material and Methods: Herein, the ELISA was developed using PA4 and LF to detect total antibody or IgG class antibody in serum. Besides, the level of anti-LF antibodies were determined as a complementary test to measure variance in antibody titers associated with vaccination or infection that leading to early detection of anthrax in livestock. Then Elisa kit was validated by checking its linearity, accuracy, precision, Quantification Limit (LOQ), Detection Limit (LOD) and specificity. The results show that we developed high-quality ELISA that can be used to test immunogenicity of vaccines and infection in mice. We tried to develop the Anti- PA4 ELISA and conduct the validation studies to evaluate the response of the antibody to the Anthrax vaccine and distinction between disease and vaccination in mice.

Journal ArticleDOI
13 Nov 2020
TL;DR: The developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.
Abstract: Preventive immunisation against anthrax is carried out in accordance with the national Immunisation Schedule for Epidemic Settings. The vaccination is performed using a live vaccine—a freeze-dried suspension of Bacillus anthracis STI-1 vaccine strain spores in a stabilizing media. Improvement of the quality control of immunobiological medicines is a pressing issue and an integral part of the quality management system. The aim of study was to streamline quality control of live anthrax vaccine in terms of the following test parameters: identification and specific activity (total spore concentration). Materials and methods : identification and specific activity (total spore concentration) tests were performed for samples of live anthrax vaccine, batch 266, produced by the 48 Central Scientific Research Institute. The identification test was performed using the B. anthracis immunochromatography test kit for express detection and identification of anthrax pathogen spores produced by the State Research Center for Applied Microbiology and Biotechnology (Obolensk). The specific activity (total spore concentration) was assessed by the visual method and calculated in the Goryaev chamber using the industry reference standard of bacterial suspension turbidity equivalent to 10 IU—OSO 42-28-85 (by the Scientific Centre for Expert Evaluation of Medicinal Products). The number of live spores in live anthrax vaccine was determined by the microbiological method (by inoculating media). The statistical processing of the results was performed using Excel and Statistica 10.0. Results : the authors provided theoretical and experimental substantiation to support the feasibility of using immunochromatography as an alternative identification test method for live anthrax vaccine. Test samples dilutions of 108 microbial cells per millilitre and 109 microbial cells per millilitre are used in the test. The authors developed a test procedure for determination of the total spore concentration (specific activity) in live anthrax vaccine using an industry reference standard of turbidity equivalent to 10 IU, and proposed a formula for calculation of the total spore concentration. Conclusions : the developed test procedures could be recommended for inclusion in the live anthrax vaccine specification files as alternative methods of quality control.

Journal ArticleDOI
TL;DR: The results suggest that the immunogenicity and protective efficacy induced by the NLAV (PrPA+FIS) in the cattle and passive mouse protection test, respectively, are comparable to that inducing by the standard SLSV.
Abstract: The Sterne live spore vaccine (SLSV, Bacillus anthracis strain 34F2) is the veterinary vaccine of choice against anthrax though contra-indicated for use with antimicrobials. However, the use of non-living anthrax vaccine (NLAV) candidates can overcome the SLSV limitation. In this study, cattle were vaccinated with either of the NLAV (purified recombinant PA (PrPA) or crude rPA (CrPA) and formaldehyde-inactivated spores (FIS of B. anthracis strain 34F2) and emulsigen-D®/alhydrogel® adjuvants) or SLSV. The immunogenicity of the NLAV and SLSV was assessed and the protective efficacies evaluated using a passive immunization mouse model. Polyclonal IgG (including the IgG1 subset) and IgM responses increased significantly across all vaccination groups after the first vaccination. Individual IgG subsets titres peaked significantly with all vaccines used after the second vaccination at week 5 and remained significant at week 12 when compared to week 0. The toxin neutralization (TNA) titres of the NLAV vaccinated cattle groups showed similar trends to those observed with the ELISA titres, except that the former were lower, but still significant, when compared to week 0. The opsonophagocytic assay indicated good antibody opsonizing responses with 75% (PrPA+FIS), 66% (CrPA+FIS) and 80% (SLSV) phagocytosis following spores opsonization. In the passive protection test, A/J mice transfused with purified IgG from cattle vaccinated with PrPA+FIS+Emulsigen-D®/Alhydrogel® and SLSV had 73% and 75% protection from challenge with B. anthracis strain 34F2 spores, respectively, whereas IgG from cattle vaccinated with CrPA+FIS+Emulsigen-D®/Alhydrogel® offered insignificant protection of 20%. There was no difference in protective immune response in cattle vaccinated twice with either the PrPA+FIS or SLSV. Moreover, PrPA+FIS did not show any residual side effects in vaccinated cattle. These results suggest that the immunogenicity and protective efficacy induced by the NLAV (PrPA+FIS) in the cattle and passive mouse protection test, respectively, are comparable to that induced by the standard SLSV.

Journal ArticleDOI
TL;DR: The results indicate that AV7909 has a favorable safety profile in juvenile rats and is warranted to support the potential emergency use of AV79 09 in children.
Abstract: AV7909 is a next-generation anthrax vaccine candidate indicated for post-exposure prophylaxis of exposure to Bacillus anthracis. AV7909 consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and the immunostimulatory Toll-like receptor 9 agonist oligodeoxynucleotide adjuvant, CPG 7909. Safety testing for pediatric population is warranted to support the potential emergency use of AV7909 in children. This study was conducted to investigate the local tolerance and potential systemic toxicity and their reversibility in juvenile rats by repeat intramuscular injections of the AV7909 vaccine candidate. Animals were dosed on postnatal day (PND) 21 (at weaning), PND 28, and PND 35, with the test article (AV7909), the adjuvant alone (Alhydrogel + CPG 7909), or sterile water for injection. Core group animals were necropsied on PND 37 and recovery group on PND 49. Study end points included survival, clinical observations, injection site observations, body weights, clinical pathology (hematology, coagulation, and clinical chemistry), pro-inflammatory biomarker analysis (alpha-2 macroglobulin [A2M] and alpha-1 acid glycoprotein [AGP]), and anatomic pathology. Immune response to vaccination was measured using the high-throughput anthrax lethal toxin neutralization assay (htpTNA). The AV7909 vaccine candidate produced no apparent systemic or local toxicity. The AGP and A2M levels were elevated in both the adjuvant-alone and AV7909 groups at the end of treatment but were comparable to control levels by the end of the recovery period. All animals in the AV7909 group demonstrated a robust neutralizing antibody response. The results indicate that AV7909 has a favorable safety profile in juvenile rats.

Journal ArticleDOI
26 Feb 2020
TL;DR: The results suggest that addition of sCMG2 to a PA vaccine formulation is likely to result in a significantly diminished immune response, but the multitude of factors that could contribute to reduced immunogenicity are discussed.
Abstract: Protective antigen (PA) is a component of anthrax toxin that can elicit toxin-neutralizing antibody responses. PA is also the major antigen in the current vaccine to prevent anthrax, but stability problems with recombinant proteins have complicated the development of new vaccines containing recombinant PA. The relationship between antigen physical stability and immunogenicity is poorly understood, but there are theoretical reasons to think that this parameter can affect immune responses. We investigated the immunogenicity of anthrax PA, in the presence and absence of the soluble von Willebrand factor A domain of the human form of receptor capillary morphogenesis protein 2 (sCMG2), to elicit antibodies to PA in BALB/c mice. Prior studies showed that sCMG2 stabilizes the 83-kDa PA structure to pH, chemical denaturants, temperature, and proteolysis and slows the hydrogen-deuterium exchange rate of histidine residues far from the binding interface. In contrast to a vaccine containing PA without adjuvant, we found that mice immunized with PA in stable complex with sCMG2 showed markedly reduced antibody responses to PA, including toxin-neutralizing antibodies and antibodies to domain 4, which correlated with fewer toxin-neutralizing antibodies. In contrast, mice immunized with PA in concert with a nonbinding mutant of sCMG2 (D50A) showed anti-PA antibody responses similar to those observed with PA alone. Our results suggest that addition of sCMG2 to a PA vaccine formulation is likely to result in a significantly diminished immune response, but we discuss the multitude of factors that could contribute to reduced immunogenicity.IMPORTANCE The anthrax toxin PA is the major immunogen in the current anthrax vaccine (anthrax vaccine adsorbed). Improving the anthrax vaccine for avoidance of a cold chain necessitates improvements in the thermodynamic stability of PA. We address how stabilizing PA using sCMG2 affects PA immunogenicity in BALB/c mice. Although the stability of PA is increased by binding to sCMG2, PA immunogenicity is decreased. This study emphasizes that, while binding of a ligand retains or improves conformational stability without affecting the native sequence, epitope recognition or processing may be affected, abrogating an effective immune response.

Patent
25 Nov 2020
TL;DR: In this paper, a method for preparing an anthrax spore vaccine and the anthrax vaccine vaccine is described. But the method is not suitable for the use in the development of a vaccine.
Abstract: The present invention relates to a method for preparing an anthrax spore vaccine and the anthrax spore vaccine. More specifically, the present invention relates to a method for preparing an anthrax spore vaccine and the anthrax spore vaccine, wherein the method comprises the following steps: culturing a spore-forming microorganism to express a target protein in the spore-forming microorganism; displaying the expressed target protein on a surface of a spore; and obtaining the spore on which the target protein is displayed on the surface from the spore-forming microorganism. The spore on which the target protein is displayed is surface-displayed in a non-fusion natural environment, and the target protein is an anthrax recombinant protective antigen (rPA). In addition, the present invention can provide an anthrax vaccine pharmaceutical composition and an anthrax immunization method using the anthrax spore vaccine.

Patent
24 Jan 2020
TL;DR: In this paper, a live dry lyophilised anthrax vaccine containing spores of the strain B. anthracis STI-1 and enclosed in solid gelatinous enteric capsules with a total spore concentration of 4.9±0.5 billion/ml and concentration of live spores 3.0± 0.4 billions/ml.
Abstract: FIELD: medicine.SUBSTANCE: invention refers to medicine and aims at vaccination of anthrax. Vaccine prophylaxis is carried out by oral administration of an effective amount of a live dry lyophilised anthrax vaccine containing spores of the strain B. anthracis STI-1 and enclosed in solid gelatinous enteric capsules with a total spore concentration of 4.9±0.5 billion/ml and concentration of live spores 3.0±0.4 billion/ml.EFFECT: method provides the formation of strained immunity and does not require special equipment and attracting qualified medical personnel.1 cl, 6 tbl, 5 ex

Journal ArticleDOI
09 Sep 2020
TL;DR: In this paper, the authors present the results of the study of strains of anthrax and anthrax bacilli on the formation of toxins, and they found that anthrax vaccine strains actively produce exotoxins to the culture fluid.
Abstract: . The article presents the results of the study of strains of anthrax and anthrax bacilli on the formation of toxins. We found that anthrax vaccine strains actively produce exotoxins to the culture fluid. The amount of specific protein is different under the same incubation conditions and depends on the individual characteristics of the population of microorganisms, because of this, different titers of the toxin are registered. Strain B. anthracis K-79 Z (vaccine) with the same number of planting microbial cells and growing on the same nutrient medium and temperature produces two orders of magnitude more exotoxin than strains of B. anthracis Tsenkovsky II IVM 92 Z (virulent), B. anthracis Stern 34F2, (vaccine), B. anthracis 55 (vaccine), B. anthracis SB (vaccine), B. anthracis Tsenkovsky I (vaccine, а pathogenic). The amount of exotoxin may change as the pH of the medium changes. The activity of exotoxin production when the pH changes depends on the characteristics of the anthrax strain. Key words : anthrax, exotoxin, exotoxin production

Journal ArticleDOI
09 Oct 2020-Vaccine
TL;DR: The findings indicate that the PrPA + FIS + Emulsigen-D®/Alhydrogel® vaccine candidate may provide the same level of antibody responses and protective capacity as the SLSV.

Journal ArticleDOI
TL;DR: The colored slide agglutination tests protocol developed in this study can be used to detect anti-anthrax immune response and anthrax bacteria in the field condition with minimum laboratory facilities.
Abstract: This study was aimed to identify humoral immune response against anthrax vaccine in mice model by using colored slide agglutination test and detection of field infectivity of anthrax. The field isolates of B. anthracis (n=05) and F34 stern strain vaccine was isolated on agar plates in order to carry out the slide agglutination test. The field isolates of B. anthracis and vaccine bacteria grew on PLET agar medium produced roughly circular and creamy white colonies with ground glass appearance. The bacteria on sheep blood agar media produced rough, sticky, white-gray non hemolytic colonies. Colony polymerase chain reaction (PCR) protocol was adapted to detect fragments of pX01 (596bp) and pX02 (777bp) plasmid of virulent field isolates of B. anthracis. The fragment of pX01 plasmid was only detected in vaccine bacteria. Growth of a field isolate and a vaccine bacteria were colored with crystal violet and used in slide agglutination test to detect anthrax antibodies. The anti-anthrax antibody was prepared by immunizing female mice with 100ul anthrax vaccine through subcutaneous route. Tail bleed were collected on day 0, 30, 60, 120 and 180 of immunization. Cardiac bleed was collected on day 180 of immunization for extensive study. 25μl of diluted (1:10, 1:20, 1:50 and 1:100) antisera and 25μl colored antigen was mixed together onto a clean slide at room temperature and the results was red following 5min, 10mins, 15mins and 20mins of reaction. Unstained antigens and non-immunized sera from the mice were used as control. Results of slide agglutination test showed that the colored vaccine bacteria and field isolates clumped the mice anti-antisera (day 30, 60, and 120) at 1:20 dilution as seen in naked eye but the reaction was seen only at 1:10 dilution while colorless antigens were used. Under microscopic investigation of slide agglutination test, the reaction was read up to 1:100 dilutions with the sera collected at day 30, 60, 120 and 180 of immunization. The Anthrax Sterne strain vaccine induced anti-anthrax immunity in mice that was detected until day 180 of immunization. The clumping reaction was distinct while colored anthrax antigen was used in slide agglutination tests. The colored slide agglutination tests protocol developed in this study can be used to detect anti-anthrax immune response and anthrax bacteria in the field condition with minimum laboratory facilities. Res. Agric., Livest. Fish.7(3): 497-506, December 2020