A systematic review and meta-analysis for the adverse effects, immunogenicity and efficacy of Lyme disease vaccines: Guiding novel vaccine development

Badawi, Alaa; Shering, Maria; Rahman, Shusmita; Lindsay, L. Robbin

doi:10.17269/cjph.108.5728

Cited by 7 publications

(5 citation statements)

References 42 publications

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“…Furthermore, others found that vaccine-induced immune responses to rOspA did not replicate the sequence of events needed in natural infection to induce treatment-resistant Lyme arthritis 45 . More recent systematic reviews and meta-analysis of published data have found that reported adverse events were not different between vaccinated and placebo groups 46 , 47 .…”

Section: Clinical Trials Of the Recombinant Ospa (Rospa) Vaccine For Lyme Disease Preventionmentioning

confidence: 96%

The year that shaped the outcome of the OspA vaccine for human Lyme disease

Dattwyler

Gomes-Solecki

2022

npj Vaccines

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The expansion of Lyme borreliosis endemic areas and the corresponding increase of disease incidence have opened the possibility for greater acceptance of a vaccine. In this perspective article, we discuss the discovery of outer surface protein A (OspA) of B. burgdorferi, and the subsequent pre-clinical testing and clinical trials of a recombinant OspA vaccine for human Lyme disease. We also discuss in detail the open public hearings of the FDA Lyme disease vaccine advisory panel held in 1998 where concerns of molecular mimicry induced autoimmunity to native OspA were raised, the limitations of those studies, and the current modifications of recombinant OspA to develop a multivalent subunit vaccine for Lyme disease.

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Section: Clinical Trials Of the Recombinant Ospa (Rospa) Vaccine For Lyme Disease Preventionmentioning

confidence: 96%

The year that shaped the outcome of the OspA vaccine for human Lyme disease

Dattwyler

Gomes-Solecki

2022

npj Vaccines

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“…No further work on this topic is warranted as a systematic review was recently published (60). Lyme vaccines are currently approved and used in dogs, and there has not been a commercial vaccine available for humans since the withdrawal of LYMErix in 2002 (61)(62)(63)(64).…”

Section: Scoping Reviewmentioning

confidence: 99%

A scoping review of Lyme disease research relevant to public health

Greig

Young

Harding

et al. 2018

CCDR

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Lyme disease (LD) is an emerging infectious disease in Canada associated with expansion of the geographic range of the tick vector Ixodes scapularis in eastern and central Canada. A scoping review of published research was prioritized to identify and characterize the scientific evidence concerning key aspects of LD to support public health efforts. Prior to initiation of this review, an expert advisory group was surveyed to solicit insight on priority topics and scope. A pre-tested search strategy implemented in eight databases (updated September 2016) captured relevant research. Pre-tested screening and data characterization forms were completed by two independent reviewers and descriptive analysis was conducted to identify topic areas with solid evidence and knowledge gaps. Of 19,353 records screened, 2,258 relevant articles were included in the review under the following six public health focus areas: a) surveillance/monitoring in North America (n=809); b) evaluation of diagnostic tests (n=736); c) risk factors (n=545); d) public health interventions (n=205); e) public knowledge, attitudes and/or perceptions in North America (n=202); and f) the economic burden of LD or cost-benefit of interventions (n=32). The majority of research investigated Borrelia burgdorferi (n=1,664), humans (n=1,154) and Ixodes scapularis (n=459). Sufficient research was identified for potential systematic reviews in four topic areas: a) accuracy of diagnostic tests; b) risk factors for human illness; c) efficacy of LD intervention strategies; and d) prevalence and/or incidence of LD in humans or B. burgdorferi sensu stricto in vertebrate reservoirs or ticks in North America. Future primary research could focus on closing knowledge gaps, such as the role of less studied vertebrate reservoirs in the transmission cycle. Results of this scoping review can be used to quickly identify and summarize relevant research pertaining to specific questions about LD or B. burgdorferi sensu lato in humans, vertebrate hosts or vectors, providing evidence-informed information within timelines that are conducive for public health decision-making.

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“… Zhao et al (2017) concluded that whilst side-effects were rare, further research on efficacy and safety was needed. Badawi et al (2017) compared monovalent vaccines (LYMErix, ImmuLyme) (neither currently available) with preliminary data for next-generation multivalent vaccines and concluded that the multivalent vaccine was slightly more tolerable than the monovalent one, which in turn was not worse than other vaccines in the USA-based Vaccine Adverse Event Reporting System (VAERS). Despite approval for the LYMErix vaccine by the US Food and Drug Administration (FDA), the LYMErix vaccine was voluntarily withdrawn from the market, in 2002, due to poor sales.…”

Section: Introductionmentioning

confidence: 99%

“…Despite approval for the LYMErix vaccine by the US Food and Drug Administration (FDA), the LYMErix vaccine was voluntarily withdrawn from the market, in 2002, due to poor sales. The replacement of monovalent vaccines with vaccines that have a similar approach may, therefore, not be the best method for new vaccine development ( Badawi et al, 2017 ).…”

Section: Introductionmentioning

confidence: 99%

Interventions to prevent Lyme disease in humans: A systematic review

Richardson

Khouja

Sutcliffe

2019

Preventive Medicine Reports

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Lyme disease (LD) is an infection transferred to humans through bites from infected ticks. Surveillance indicates that the number of LD cases is increasing in the UK, therefore, improved knowledge about reducing transmission from ticks to humans is needed. Eighteen electronic databases were searched and additional web-based searching was conducted, to locate empirical research, published from 2002 onwards. Sixteen studies that evaluated five types of prevention intervention were included: personal protection (n = 4), domestic strategies (landscape modification and chemical pest control) (n = 3), education (n = 6), vaccination (n = 3), and deer-reduction programmes (n = 2). In general the quality of evidence was low. Results suggest that personal protection strategies, including the use of tick repellents and wearing of protective clothes, can prevent tick bites and reduce the incidence of LD among adults. Educational interventions were generally successful for improving adults' knowledge, behavioural beliefs (e.g., self-efficacy for performing tick checks) and preventative behaviour, but for children, the findings were mixed. For adults and children, knowledge changes did not typically translate into a lower incidence of LD. Whilst evidence on vaccination against LD is promising, too few studies were available to reach robust conclusions. There was no evidence of effectiveness for deer culling, and the evidence was inconclusive for applying acaricide (tick poison) to deer's ears and heads. Low-quality evidence suggests that personal protective strategies, that limit exposure to ticks, should continue to be recommended, as should education to encourage the adoption of personal protective strategies; further investigation of education interventions for children, vaccination and deer programmes is needed.

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A systematic review and meta-analysis for the adverse effects, immunogenicity and efficacy of Lyme disease vaccines: Guiding novel vaccine development

Abstract: BACKGROUND: Lyme borreliosis (LB) is the most prevalent arthropod-borne infectious disease in North America. Currently, no vaccine is available to prevent LB in humans, although monovalent and multivalent vaccines have been developed in the past.

Cited by 7 publications

References 42 publications

The year that shaped the outcome of the OspA vaccine for human Lyme disease

The year that shaped the outcome of the OspA vaccine for human Lyme disease

A scoping review of Lyme disease research relevant to public health

Interventions to prevent Lyme disease in humans: A systematic review

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