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Lyme disease is caused by the spirochete, Borrelia burgdorferi, which is transmitted by Ixodes spp ticks. The rise in Lyme disease cases since its discovery in the 1970s has reinforced the need for a vaccine. A vaccine based on B burgdorferi outer surface protein A (OspA) was approved by the Food and Drug Administration (FDA) several decades ago, but was pulled from the market a few years later, reportedly due to poor sales, despite multiple organizations concluding that it was safe and effective. Newer OspA-based vaccines are being developed and are likely to be available in the coming years. More recently, there has been a push to develop vaccines that target the tick vector instead of the pathogen to inhibit tick feeding and thus prevent transmission of tick-borne pathogens to humans and wildlife reservoirs. This review outlines the history of Lyme disease vaccines and this movement to anti-tick vaccine approaches. [ABSTRACT FROM AUTHOR]

Lyme disease (LD) is the most common vector-borne disease in the United States, with increasing incidence and geographic range. Case incidence peaks among school-aged children. New LD preventives are in clinical trials. We conducted an online survey of parents of children aged 5–18 years in states with high or emerging incidence of LD. Our primary outcome was willingness ("definitely" or "probably") for their child to receive an LD vaccine. Our secondary outcome was preference for annual monoclonal antibody injections compared to a 3-dose vaccine series with boosters. Analyses were weighted to reflect parent gender, parent race/ethnicity, and child age by state. Among 1,351 parent respondents, most (68.0 %) would have their child vaccinated against LD, with significantly more being willing in high compared to emerging incidence states (70.4 % versus 63.6 %, p = 0.027). Of parents who were unsure or unwilling, 33.5 % and 16.5 %, respectively, would do so with a provider recommendation. Vaccine safety concerns were among the top reasons for LD vaccine hesitancy. More parents preferred a pre-formed antibody (42.3 %) compared to a 3-dose vaccine series (34.7 %). Significant predictors of willingness to have one's child vaccinated were higher parental education; higher perceived risk of child getting LD; child spending time outdoors daily or weekly; following a regular vaccine schedule; and positive attitude towards vaccines. Significant predictors of preference for monoclonal antibody over a 3-dose vaccine series included prior awareness of LD, living in a rural area, and less positive attitudes towards vaccines. Two-thirds of parents in high and emerging incidence states would vaccinate their children against Lyme disease. Addressing safety concerns will be important, and a health care provider recommendation could also encourage those who are unsure or unwilling. Given the slight preference for monoclonal antibody over vaccine, particularly in rural areas, access to both may increase LD prevention. [ABSTRACT FROM AUTHOR]

Working together, two major pharmaceutical companies have developed a Lyme disease vaccine consisting of recombinant-derived outer surface protein A (OspA) of the etiologic agent Borrelia burgdorferi. Multiple clinical trials have shown the vaccine to have good safety and efficacy results, and it is hoped that it would become available for human use at least by the year 2025 after receiving approval from the U.S. Food and Drug Administration. There are still challenges left to ensure that the vaccine has, at most, minimal side effects. Also, because the previously developed Lyme disease vaccine was discontinued in 2002 after four years of distribution, due in part, for frivolous reasons having little or no scientific basis, that even led to legal entanglements involving the vaccine manufacturer and some of themedical personnel overseeing the clinical trials, there will be concerns that this newly developed one could be subject again to some of the same unnecessary scrutiny rendering its implementation suboptimal. Initially this review will focus on the key epidemiological, microbiologic, immunologic and clinical aspects of Lyme disease that provide the foundation for developing this type of vaccine that could have a serious impact on the prevalence of this and even certain other tick-transmitted infections. [ABSTRACT FROM AUTHOR]

Lyme disease (LD) caused by Borrelia burgdorferi is among the most important human vector borne diseases for which there is no effective prevention method. Identification of tick saliva transmission factors of the LD agent is needed before the highly advocated tick antigen-based vaccine could be developed. We previously reported the highly conserved Ixodes scapularis (Ixs) tick saliva serpin (S) 17 (IxsS17) was highly secreted by B. burgdorferi infected nymphs. Here, we show that IxsS17 promote tick feeding and enhances B. burgdorferi colonization of the host. We show that IxsS17 is not part of a redundant system, and its functional domain reactive center loop (RCL) is 100% conserved in all tick species. Yeast expressed recombinant (r) IxsS17 inhibits effector proteases of inflammation, blood clotting, and complement innate immune systems. Interestingly, differential precipitation analysis revealed novel functional insights that IxsS17 interacts with both effector proteases and regulatory protease inhibitors. For instance, rIxsS17 interacted with blood clotting proteases, fXII, fX, fXII, plasmin, and plasma kallikrein alongside blood clotting regulatory serpins (antithrombin III and heparin cofactor II). Similarly, rIxsS17 interacted with both complement system serine proteases, C1s, C2, and factor I and the regulatory serpin, plasma protease C1 inhibitor. Consistently, we validated that rIxsS17 dose dependently blocked deposition of the complement membrane attack complex via the lectin complement pathway and protected complement sensitive B. burgdorferi from complement-mediated killing. Likewise, co-inoculating C3H/HeN mice with rIxsS17 and B. burgdorferi significantly enhanced colonization of mouse heart and skin organs in a reverse dose dependent manner. Taken together, our data suggests an important role for IxsS17 in tick feeding and B. burgdorferi colonization of the host. Author summary: Ticks feed on animals and humans for their survival. During blood meal feeding, ticks inject saliva along with disease causative agents into the hosts. Here, we demonstrate that I. scapularis tick saliva protein, IxsS17 inhibits host innate immune system proteases and enhances B. burgdorferi colonization of the host. Recombinant IxsS17 (rIxsS17) inhibits blood clotting and inflammation systems serine proteases including pancreatic trypsin and trypsin IV (~100%), blood clotting factor Xa and XIa (~60–80%), plasmin and cathepsin G (~50%). Similarly, rIxsS17 interacts with complement system factors, C1s, C2 and factor I and blocks complement membrane attack complex via the lectin complement pathway by up to 97%. We found that, in the mouse model for Lyme disease, rIxsS17 significantly increases B. burgdorferi colonization of mouse heart and ear tissues by 5.7 and 2.3 times. Taken together, we conclude that IxsS17 is a key protein in tick feeding and B. burgdorferi colonization of the host, and thus, a potential target antigen for developing tick antigen-based vaccines against Lyme disease agent transmission. [ABSTRACT FROM AUTHOR]

Background incidence rates (IRs) of health outcomes in Lyme disease endemic regions are useful to contextualize events reported during Lyme disease vaccine clinical trials or post-marketing. The objective of this study was to estimate and compare IRs of health outcomes in Lyme disease endemic versus non-endemic regions in the US during pre-COVID and COVID era timeframes. IQVIA PharMetrics® Plus commercial claims database was used to estimate IRs of 64 outcomes relevant to vaccine safety monitoring in the US during January 1, 2017-December 31, 2019 and January 1, 2020-December 31, 2021. Analyses included all individuals aged ≥ 2 years with ≥ 1 year of continuous enrollment. Outcomes were defined by International Classification of Diseases Clinical Modification, 10th Revision (ICD-10-CM) diagnosis codes. IRs and 95 % confidence intervals (CIs) were calculated for each outcome and compared between endemic vs. non-endemic regions, and pre-COVID vs. COVID era using IR ratios (IRR). The study population included 8.7 million (M) in endemic and 27.8 M in non-endemic regions. Mean age and sex were similar in endemic and non-endemic regions. In both study periods, the IRs were statistically higher in endemic regions for anaphylaxis, meningoencephalitis, myocarditis/pericarditis, and rash (including erythema migrans) as compared with non-endemic regions. Conversely, significantly lower IRs were observed in endemic regions for acute kidney injury, disseminated intravascular coagulation, heart failure, myelitis, myopathies, and systemic lupus erythematosus in both study periods. Most outcomes were statistically less frequent during the COVID-era. This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions during pre-COVID and COVID era timeframes to inform Lyme disease vaccine safety monitoring. These regional and temporal differences in background IRs should be considered when contextualizing possible safety signals in clinical trials and post-marketing of a vaccine targeted at Lyme disease prevention. [ABSTRACT FROM AUTHOR]

Strategies for disease control are necessary to reduce incidence of Lyme Disease (LD) including development of safe vaccines for human use. Parainfluenza virus 5 (PIV5) vector has an excellent safety record in animals and PIV5-vectored vaccines are currently under clinical development. We constructed PIV5-vectored LD vaccine candidates expressing OspA from B. burgdorferi (OspAB31) and a chimeric protein containing sequences from B. burgdorferi and B. afzelii (OspABPBPk). Immunogenicity and vaccine efficacy were analyzed in C3H-HeN mice after prime-boost intranasal vaccination with live PIV5-OspAB31 or PIV5-OspABPBPk, subcutaneous (s.c.) vaccination with rOspAB31+Alum, and the respective controls. Mice vaccinated intranasally with live PIV5-AB31 or PIV5-ABPBPk had higher endpoint titers of serum antibody against OspAB31 at 6- and 12- months post vaccination, compared to mice vaccinated s.c. with rOspAB31. Neutralization activity of antibody was maintained up to 18-months post-immunization, with the response greater in live PIV5-delivered OspA vaccines, than that induced by s.c. rOspAB31. Challenge with infected ticks carrying 10-19 strains of B. burgdorferi performed at 4-, 9- or 15-months post-immunization showed increased breakthrough infections in mice vaccinated with s.c. rOspAB31 compared to intranasal PIV5-AB31 or PIV5-ABPBPk at 9- and 15-months, as determined by quantification of serologic antibodies to B. burgdorferi proteins as well as flaB DNA in tissues, and by visualization of motile B. burgdorferi in culture of tissues under dark field microscope. These findings indicate that immunization of mice with PIV5 delivered OspA generates immune responses that produce longer-lasting protection (> 1 year) against tick-transmitted B. burgdorferi than a parenteral recombinant OspA vaccine. [ABSTRACT FROM AUTHOR]

Lyme disease (LD) is the most common tick-borne illness in the United States (U.S.), Europe, and Asia. Borrelia burgdorferi, a spirochete bacterium transmitted by the tick vector Ixodes scapularis, causes LD in the U.S. If untreated, Lyme arthritis, heart block, and meningitis can occur. Given the absence of a human Lyme disease vaccine, we developed a vaccine using the rabies virus (RABV) vaccine vector BNSP333 and an outer surface borrelial protein, BBI39. BBI39 was previously utilized as a recombinant protein vaccine and was protective in challenge experiments; therefore, we decided to utilize this protective antigen in a rabies virus-vectored vaccine against Borrelia burgdorferi. To incorporate BBI39 into the RABV virion, we generated a chimeric BBI39 antigen, BBI39RVG, by fusing BBI39 with the final amino acids of the RABV glycoprotein by molecular cloning and viral recovery with reverse transcription genetics. Here, we have demonstrated that the BBI39RVG antigen was incorporated into the RABV virion via immunofluorescence and Western blot analysis. Mice vaccinated with our BPL inactivated RABV-BBI39RVG (BNSP333-BBI39RVG) vaccine induced high amounts of BBI39-specific antibodies, which were maintained long-term, up to eight months post-vaccination. The BBI39 antibodies neutralized Borrelia in vaccinated mice when challenged with Borrelia burgdorferi by either syringe injection or infected ticks and they reduced the Lyme disease pathology of arthritis in infected mouse joints. Overall, the RABV-based LD vaccine induced more and longer-term antibodies compared to the recombinant protein vaccine. This resulted in lower borrelial RNA in RABV-based vaccinated mice compared to recombinant protein vaccinated mice. The results of this study indicate the successful use of BBI39 as a vaccine antigen and RABV as a vaccine vector for LD. [ABSTRACT FROM AUTHOR]

The article focuses on the paramount importance of adhering to Good Clinical Practice (GCP) in the realm of clinical trials. It highlights a pivotal incident where Pfizer severed ties with CareAccess, a decentralized clinical trial specialist, due to unspecified GCP violations. It further addresses the challenges posed by protocol deviations inherent in clinical trials and emphasizes that thorough training can mitigate these issues.

To reduce vaccine-preventable diseases in workers, workplace vaccination campaigns can be implemented on-site. The aim of this systematic review was to evaluate adherence to workplace vaccination campaigns. Three databases, PubMed, ISI Web of Science, and Scopus, were screened systematically for articles in English or Italian addressing participation in an on-site vaccination program by employees. The following data was extracted: authors, year, country, type of vaccine, type of workplace, sample size, vaccination rate. Data on the prevalence of flu vaccination were calculated and pooled using a random-effects model. Thirteen articles were included in the review, ten in the meta-analysis. Most studies were conducted in the USA (30.7%) and most vaccination campaigns were against influenza (69.2%), with a pooled estimate of 42% (95% CI: 0.25–0.60%); participation rate was highly variable, ranging from 88.9% for an influenza vaccination campaign to 5.7% for a Lyme disease vaccination campaign. Offering free on-site vaccination can be a successful tool to ensure adherence to vaccination campaigns and administration of all required doses according to the vaccine administration scheme. The occupational physician can play a key role in implementing workplace campaigns for employee mandatory vaccinations. [ABSTRACT FROM AUTHOR]

Lyme disease, caused by the bacterium Borrelia burgdorferi , is the most common tick-borne illness in the United States. Despite the rise in Lyme disease incidence, there is no vaccine against B. burgdorferi approved for human use. Little is known about the immune correlates of protection needed to prevent Lyme disease. In this work, a mouse model was used to characterize the immune response and compare the protection provided by two USDA-approved vaccines for use in canines: Duramune (bacterin vaccine) and Vanguard crLyme (subunit vaccine composed of two outer surface proteins, OspA and OspC). C3H/HeNCrl mice were immunized with two doses of either Duramune or Vanguard, and immune responses and protection against B. burgdorferi were assessed in short (35 days) and long-term (120 days) studies. Flow cytometry, ELISPOT detection of antibody-producing cells, and antibody affinity studies were performed to identify correlates of vaccine-mediated protection. Both vaccines induced humoral responses, with high IgG titers against B. burgdorferi. However, the levels of anti- B. burgdorferi antibodies decayed over time in Vanguard-vaccinated mice. While both vaccines triggered the production of antibodies against both OspA and OspC, antibody levels against these proteins were also lower in Vanguard-vaccinated mice 120 days post-vaccination. Both vaccines only provided partial protection against B. burgdorferi at the dose used in this model. The protection provided by Duramune was superior to Vanguard 120 days post-vaccination, and was characterized by higher antibody titers, higher abundance of long-lived plasma cells, and higher avidity antibodies than Vanguard. Overall, these studies provide insights into the importance of the humoral memory response to veterinary vaccines against Lyme disease and will help inform the development of future human vaccines. [ABSTRACT FROM AUTHOR]

Transmitted by ticks, Lyme disease is the most common vector-borne disease in the Northern hemisphere. Despite the geographical expansion of human Lyme disease cases, no effective preventive strategies are currently available. Developing an efficacious and safe vaccine is therefore urgently needed. Efforts have previously been taken to identify vaccine targets in the causative pathogen (Borrelia burgdorferi sensu lato) and arthropod vector (Ixodes spp.). However, progress was impeded due to a lack of consumer confidence caused by the myth of undesired off-target responses, low immune responses, a limited breadth of immune reactivity, as well as by the complexities of the vaccine process development. In this review, we summarize the antigen engineering approaches that have been applied to overcome those challenges and the underlying mechanisms that can be exploited to improve both safety and efficacy of future Lyme disease vaccines. Over the past two decades, several new genetically redesigned Lyme disease vaccine candidates have shown success in both preclinical and clinical settings and built a solid foundation for further development. These studies have greatly informed the protective mechanisms of reducing Lyme disease burdens and ending the endemic of this disease. [ABSTRACT FROM AUTHOR]

The tick-borne bacterium, Borrelia burgdorferi has been implicated in Lyme disease—a deadly infection, formerly confined to North America, but currently widespread across Europe and Asia. Despite the severity of this disease, there is still no human Lyme disease vaccine available. A reliable immunoinformatic approach is urgently needed for designing a therapeutic vaccine against this Gram-negative pathogen. Through this research, we explored the immunodominant proteins of B. burgdorferi and developed a novel and reliable vaccine design with great immunological predictability as well as low contamination and autoimmunity risks. Our initial analysis involved proteome-wide analysis to filter out proteins on the basis of their redundancy, homology to humans, virulence, immunogenicity, and size. Following the selection of proteins, immunoinformatic tools were employed to identify MHC class I & II epitopes and B-cell epitopes, which were subsequently subjected to a rigorous screening procedure. In the final formulation, ten common MHC-I and II epitopes were used together with a suitable adjuvant. We predicted that the final chimeric multi-epitope vaccine could invoke B-cell responses and IFN-gamma-mediated immunity as well as being stable and non-allergenic. The dynamics simulations predicted the stable folding of the designed molecule, after which the molecular docking predicted the stability of the interaction between the potential antigenic epitopes and human immune receptors. Our studies have shown that the designed next-generation vaccine stimulates desirable immune responses, thus potentially providing a viable way to prevent Lyme disease. Nevertheless, further experimental studies in a wet lab are needed in order to validate the results. [ABSTRACT FROM AUTHOR]

Aims: A growing number of Lyme disease (LD) cases in the U.S. are reported in states neighbouring those with high-incidence (>10 cases per 100,000 population) rates. Considering the evolving epidemiology, high-incidence counties in many of these "neighbouring states," and the forthcoming vaccines, understanding the drivers of vaccination intention is critical, particularly how drivers of intention in neighbouring states vary relative to regions currently classified as high incidence. This study uses the Health Belief Model (HBM) to determine the key drivers associated with vaccine intention for U.S. adults and caregivers of children residing in neighbouring states., Methods and Results: Using an established panel with quotas for age, sex, race/ethnicity and urbanity, we surveyed 887 adults and 822 caregivers of children residing in U.S. neighbouring states. Survey items included measures of intention and HBM constructs, all of which were assessed using 5-point Likert scales. We subsequently used structural equation modelling to understand the influence of the HBM constructs on LD vaccine intention. Estimates from structural equation modelling show that the HBM constructs explain much of the variation in intention to vaccinate against LD. Intentions to vaccinate for both adults and caregivers are positively influenced by cues to action, perceived susceptibility of LD, and perceived benefits to vaccination. Both are also negatively influenced by perceived barriers to vaccination. The caregiver's intention to vaccinate is also positively influenced by the perceived severity of LD., Conclusion: The intention to vaccinate for respondents residing in LD neighbouring states is strongly influenced by recommendations from healthcare providers or the Centers for Disease Control and Prevention (CDC). As incidence rises in neighbouring states and the need to prevent disease becomes more overt, public health officials should strongly recognize the influence of healthcare providers and CDC recommendations on intention to vaccinate against LD., (© 2024 The Authors. Zoonoses and Public Health published by Wiley‐VCH GmbH.)

To further describe the incidence of LB within countries, a systematic literature review abstracted published national and subnational level incidence data for the period 2005-2020. The first country-specific analysis, by Nuttens et al, reports and compares three sources of LB incidence data for France: the "Sentinelles" network (national surveillance of general practitioners), a separate general practitioners EMR data system, and the French national hospital discharge database. Since the observation of EM in Europe and its recognition as Lyme borreliosis (LB), documentation of the disease's epidemiology has evolved substantially. [Extracted from the article]

• 64% of the sample indicated willingness to get a Lyme disease vaccine. • 30% were uncertain about getting a Lyme disease vaccine; 7% were unwilling. • The uncertain were parents, were non-white, and had vaccine safety concerns. • Safety messaging should be delivered by clinicians, especially to uncertain groups. • More studies will be useful once Lyme disease vaccine parameters are available. Lyme disease incidence is increasing, despite current prevention options. New Lyme disease vaccine candidates are in development, however, investigation of the acceptability of a Lyme disease vaccine among potential consumers is needed prior to any vaccine coming to market. We conducted a population-based, cross-sectional study to estimate willingness to receive a potential Lyme disease vaccine and factors associated with willingness. The web-based survey was administered to a random sample of Connecticut, Maryland, Minnesota, and New York residents June–July 2018. Survey-weighted descriptive statistics were conducted to estimate the proportion willing to receive a potential Lyme disease vaccine. Multivariable multinomial logistic regression models were used to quantify the association of sociodemographic characteristics and Lyme disease vaccine attitudes with willingness to be vaccinated. Surveys were completed by 3313 respondents (6% response rate). We estimated that 64% of residents were willing to receive a Lyme disease vaccine, while 30% were uncertain and 7% were unwilling. Compared to those who were willing, those who were uncertain were more likely to be parents, adults 45–65 years old, non-White, have less than a bachelor's degree, or have safety concerns about a potential Lyme disease vaccine. Those who were unwilling were also more likely to be non-White, have less than a bachelor's degree, or have safety concerns about a potential Lyme disease vaccine. In addition, the unwilling had low confidence in vaccines in general, had low perceived risk of contracting Lyme disease, and said they would not be influenced by a positive recommendation from a healthcare provider. Overall, willingness to receive a Lyme disease vaccine was high. Effective communication by clinicians regarding safety and other vaccine parameters to those groups who are uncertain will be critical for increasing vaccine uptake and reducing Lyme disease incidence. [ABSTRACT FROM AUTHOR]

The relevance of this study is conditioned upon the substantial importance of the history of the discovery and research of Lyme borreliosis for medical science and veterinary medicine, since new theories, experiments, conclusions are built on the research of scientists who have proved the existence of this disease in animals and humans, and positive practices are accumulated regarding methods and schemes of treatment and prevention. The purpose of this study was to analyse the literature primary sources covering the history of the discovery, the results of the study of Lyme borreliosis disease to understand the features of its course and search for effective diagnostic and treatment methods. The chronology of the main results confirming the existence of Lyme borreliosis caused by Ixodidae ticks is summarised. Scientific sources covering the history of the discovery and research of Lyme borreliosis were analysed to understand the features of its course and search for effective methods of laboratory diagnostics and treatment. The main projects of the European Union programme aimed at financing research and innovative development "Horizon 2020" were determined. It was found that the projects in the field of Lyme borreliosis research also relate to certain topics, namely the creation of tests for the detection of Lyme disease, the study of the vectors of the causative agents of this disease, the development of an appropriate vaccine, and the assessment of the risks of consequences for human and animal health. It was concluded that the main areas of research are as follows: persistence of diseases and their causative agents transmitted by Ixodidae ticks; natural control of Ixodidae ticks; detection of pathogens in Ixodidae ticks; level of infection of vertebrates; habitats and natural foci of vectors and their hosts; testing and medical trials; effect of magnetic field on Borrelia; genome mapping of Borrelia species, visualisation of the human brain for disease research; research by polymerase chain reaction; endocrine studies; immune complexes, diagnosis of neuropsychiatric complications in children and adults. The practical value of this study lies in the awareness of modern scientists about the chronology of the study of Lyme borreliosis, the main ways of distribution and methods of its diagnosis in animals and humans, determining the prospects for further research according to the topical issues covered in this paper, which are solved within the framework of international projects [ABSTRACT FROM AUTHOR]

Aims: Lyme disease (LD) cases in the United States are estimated to be approaching 500,000 annually. Protective measures, such as repellent use and wearing protective clothing are recommended by public health officials. However, no protective measure has been proven to be consistently effective, partly because they require consistent and persistent behaviour change. While safe and effective vaccines are in development, it is unclear what factors influence the intention to vaccinate against LD. This study uses the Health Belief Model (HBM) framework to determine key drivers associated with vaccine intention. The HBM is widely applied in public health research and uses the following constructs: perceived susceptibility and severity of disease, perceived benefits and barriers to disease prevention, and cues to action for disease prevention to predict health behaviours. To date, the HBM framework has not been applied to vaccination intention for LD., Methods and Results: Data were collected from 874 adults and 834 caregivers of children residing in US states endemic to LD. Sampling adults and caregivers allows us to explore how the intention to vaccinate differs among those at-risk. Estimates from structural equation modelling (SEM) show that the HBM constructs explain much of the variation in intention to vaccinate against LD. Both adult and caregiver intentions to vaccinate are positively influenced by cues to action, perceived susceptibility of LD, and perceived benefits to vaccination. However, there is variation in the influence of constructs across the samples. Caregiver's intention to vaccinate is positively influenced by the perceived severity of LD and negatively influenced by safety concerns about the vaccine, whereas adult intention is negatively influenced by perceived barriers to vaccination., Conclusion: A strong relationship of cues to action on vaccine intention in samples of adults and caregivers suggests the importance of a recommendation from a healthcare provider or the Centers for Disease Control and Prevention (CDC)., (© 2024 Pfizer Inc. Zoonoses and Public Health published by Wiley‐VCH GmbH.)

Each year, over 450 000 Lyme disease diagnoses are estimated to occur in the United States, and current preventive measures have been insufficient to stem the rising incidence. An effective human Lyme disease vaccine could be a powerful intervention for population-level impact. In advance of new Lyme disease vaccines coming to market, this study explored barriers to acceptability and motivations for the uptake of a new Lyme disease vaccine. Researchers conducted 9 online focus groups among consumers who may potentially benefit from the vaccine and 30 in-depth interviews among clinician groups who may provide the vaccine. All participants were recruited from three US regions of high Lyme disease incidence. Researchers found that participants shared common motivators to either recommend (clinicians) or accept (consumers) a Lyme disease vaccine, largely driven by perceived benefits of the vaccine, the lack of current effective preventive measures and a greater peace of mind. The concern about the challenges associated with diagnosing and treating Lyme disease is a primary motivator for clinicians to recommend the vaccine, while the concern about getting Lyme disease is a primary motivator for consumers to desire the vaccine. [ABSTRACT FROM AUTHOR]

Lyme disease, caused by Lyme Borrelia spirochetes, is the most common vector-borne illness in the United States. Despite its global significance, with an estimated 14.5 % seroprevalence, there is currently no licensed vaccine. Previously, we demonstrated that CspZ-YA protein conferred protection against Lyme Borrelia infection, making it a promising vaccine candidate. However, such a protein was tagged with hexahistidine, and thus not preferred for vaccine development; furthermore, the formulation to stabilize the protein was understudied. In this work, we developed a two-step purification process for tag-free E. coli -expressed recombinant CspZ-YA. We further utilized various bioassays to analyze the protein and determine the suitable buffer system for long-term storage and formulation as a vaccine immunogen. The results indicated that a buffer with a pH between 6.5 and 8.5 stabilized CspZ-YA by reducing its surface hydrophobicity and colloidal interactions. Additionally, low pH values induced a change in local spatial conformation and resulted in a decrease in α-helix content. Lastly, an optimal salinity of 22–400 mM at pH 7.5 was found to be important for its stability. Collectively, this study provides a fundamental biochemical and biophysical understanding and insights into the ideal stabilizing conditions to produce CspZ-YA recombinant protein for use in vaccine formulation and development. [ABSTRACT FROM AUTHOR]

Camelid-derived, single-domain antibodies (V H Hs) have proven to be extremely powerful tools in defining the antigenic landscape of immunologically heterogeneous surface proteins. In this report, we generated a phage-displayed V H H library directed against the candidate Lyme disease vaccine antigen, outer surface protein A (OspA). Two alpacas were immunized with recombinant OspA serotype 1 from Borrelia burgdorferi sensu stricto strain B31, in combination with the canine vaccine RECOMBITEK Lyme containing lipidated OspA. The phage library was subjected to two rounds of affinity enrichment ("panning") against recombinant OspA, yielding 21 unique V H Hs within two epitope bins, as determined through competition enzyme linked immunosorbent assays (ELISAs) with a panel of OspA-specific human monoclonal antibodies. Epitope refinement was conducted by hydrogen exchange-mass spectrometry. Six of the monovalent V H Hs were expressed as human IgG1-Fc fusion proteins and shown to have functional properties associated with protective human monoclonal antibodies, including B. burgdorferi agglutination, outer membrane damage, and complement-dependent borreliacidal activity. The V H Hs displayed unique reactivity profiles with the seven OspA serotypes associated with B. burgdorferi genospecies in the United States and Europe consistent with there being unique epitopes across OspA serotypes that should be considered when designing and evaluating multivalent Lyme disease vaccines., Competing Interests: The authors declare no conflict of interest.

The article offers information on drug approvals which are Librela, an injectable monoclonal antibody for the control of canine osteoarthritis (OA) pain, and Borrelia Burgdorferi Bacterin, an oral vaccine against Lyme disease spread by wildlife. Librela targets nerve growth factor to provide long-term pain control in dogs with OA, while the vaccine is designed to be consumed by mice and aims to reduce the transmission of Lyme disease by ticks.

• Currently, the U.S. lacks a Lyme disease preventative vaccine. • Climate change concerns may increase public demand for a new Lyme vaccine. • In a representative survey, concern is associated with increased vaccination intentions. • Effects are strongest in the Midwest, where Lyme presents a growing health threat. • These effects hold when accounting for other potential determinants of vaccine demand. [ABSTRACT FROM AUTHOR]