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Safety of inadvertent administration of live zoster vaccine to immunosuppressed individuals in a UK-based observational cohort analysis

Por: Grint · D. J. · McDonald · H. I. · Walker · J. L. · Amirthalingam · G. · Andrews · N. · Thomas · S.
Objectives

To investigate the safety of live attenuated varicella zoster vaccination when administered to immunosuppressed individuals.

Design

Prospective observational cohort study.

Setting

The study used anonymised data from the Clinical Practice Research Datalink (CPRD), comprising a representative sample of routinely collected primary care data in England between 2013 and 2017 and and linked Hospital Episode Statistics data.

Participants

168 767 individuals age-eligible for varicella zoster vaccination registered at a general practice in England contributing data to CPRD.

Main outcome measures

Electronic health records indicating immunosuppression, zoster vaccination, diagnoses of specific varicella-zoster virus (VZV)-related disease and non-specific rash/encephalitis compatible with VZV-related disease.

Results

Between 1 September 2013 and 31 August 2017, a period of immunosuppression was identified for 9093/168 767 (5.4%; 95% CI: 5.3%–5.5%) individuals age-eligible for zoster vaccination. The overall rate of vaccination while immunosuppressed was 1742/5251 (33.2 per 100 adjusted person years at risk; 95% CI: 31.9%–34.5%). Follow-up of the 1742 individuals who were inadvertently vaccinated while immunosuppressed identified only two cases of VZV-related disease within 8 weeks of vaccination (0.1%; 95% CI: 0.01%–0.4%), both primary care diagnoses of ‘shingles’, neither with a related hospital admission.

Conclusions

Despite evidence of inadvertent vaccination of immunosuppressed individuals with live zoster vaccination, there is a lack of evidence of severe consequences including hospitalisation. This should reassure primary care staff and encourage vaccination of mildly immunosuppressed individuals who do not meet current thresholds for contraindication. These findings support a review of the extent to which live zoster vaccination is contraindicated among the immunosuppressed.

Using population-wide administrative and laboratory data to estimate type- and subtype-specific influenza vaccine effectiveness: a surveillance protocol

Por: Scott · A. N. · Buchan · S. A. · Kwong · J. C. · Drews · S. J. · Simmonds · K. A. · Svenson · L. W.
Introduction

The appropriateness of using routinely collected laboratory data combined with administrative data for estimating influenza vaccine effectiveness (VE) is still being explored. This paper outlines a protocol to estimate influenza VE using linked laboratory and administrative data which could act as a companion to estimates derived from other methods.

Methods and analysis

We will use the test-negative design to estimate VE for each influenza type/subtype and season. Province-wide individual-level records of positive and negative influenza tests at the Provincial Laboratory for Public Health in Alberta will be linked, by unique personal health numbers, to administrative databases and vaccination records held at the Ministry of Health in Alberta to determine covariates and influenza vaccination status, respectively. Covariates of interests include age, sex, immunocompromising chronic conditions and healthcare setting. Cases will be defined based on an individual’s first positive influenza test during the season, and potential controls will be defined based on an individual’s first negative influenza test during the season. One control for each case will be randomly selected based on the week the specimen was collected. We will estimate VE using multivariable logistic regression.

Ethics and dissemination

Ethics approval was obtained from the University of Alberta’s Health Research Ethics Board—Health Panel under study ID Pro00075997. Results will be disseminated by public health officials in Alberta.

Autologous platelet‐rich plasma for healing chronic venous leg ulcers: Clinical efficacy and potential mechanisms

The overall quality of evidence of autologous platelet‐rich plasma (PRP) for treating chronic wounds remains low. While further well‐designed clinical studies are clearly required to convincingly demonstrate the efficacy of autologous PRP in improved healing of venous leg ulcers (VLUs) and other chronic wounds, there is also an increasing need to better define the underlying mechanisms of action and whether positive outcomes can be predicted based on the analysis of PRP. This brief review will discuss the current understanding of autologous PRP in VLUs and whether molecular evaluation of PRP at the time of collection could potentially be informative to clinical outcomes. Benefits of the autologous PRP treatment strategy include that PRP is easily accessible and is relatively inexpensive and safe. Better understanding of the mechanisms involved could improve treatment, enable supplementation, and/or lead to gains in product development. Analysis of PRP could also add value to future clinical trials on efficacy and potentially personalised treatment regimens.

Serological surveillance of influenza in an English sentinel network: pilot study protocol

Por: de Lusignan · S. · Borrow · R. · Tripathy · M. · Linley · E. · Zambon · M. · Hoschler · K. · Ferreira · F. · Andrews · N. · Yonova · I. · Hriskova · M. · Rafi · I. · Pebody · R.
Background

Rapidly undertaken age-stratified serology studies can produce valuable data about a new emerging infection including background population immunity and seroincidence during an influenza pandemic. Traditionally seroepidemiology studies have used surplus laboratory sera with little or no clinical information or have been expensive detailed population based studies. We propose collecting population based sera from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), a sentinel network with extensive clinical data.

Aim

To pilot a mechanism to undertake population based surveys that collect serological specimens and associated patient data to measure seropositivity and seroincidence due to seasonal influenza, and create a population based serology bank.

Methods and analysis

Setting and Participants: We will recruit 6 RCGP RSC practices already taking nasopharyngeal virology swabs. Patients who attend a scheduled blood test will be consented to donate additional blood samples. Approximately 100–150 blood samples will be collected from each of the following age bands – 18– 29, 30– 39, 40– 49, 50– 59, 60– 69 and 70+ years.

Methods

We will send the samples to the Public Health England (PHE) Seroepidemiology Unit for processing and storage. These samples will be tested for influenza antibodies, using haemagglutination inhibition assays. Serology results will be pseudonymised, sent to the RCGP RSC and combined using existing processes at the RCGP RSC secure hub. The influenza seroprevalence results from the RCGP cohort will be compared against those from the annual PHE influenza residual serosurvey.

Ethics and dissemination

Ethical approval was granted by the Proportionate Review Sub- Committee of the London – Camden & Kings Cross on 6 February 2018. This study received approval from Health Research Authority on 7 February 2018. On completion the results will be made available via peer-reviewed journals.

Cohort profile: the Buffalo OsteoPerio microbiome prospective cohort study

Por: Banack · H. R. · Genco · R. J. · LaMonte · M. J. · Millen · A. E. · Buck · M. J. · Sun · Y. · Andrews · C. A. · Hovey · K. M. · Tsompana · M. · McSkimming · D. I. · Zhao · J. · Wactawski-Wende · J. · for the OsteoPerio Study Group
Purpose

The Buffalo Osteoporosis and Periodontal Disease (OsteoPerio) study is a prospective cohort study focused on the relationship between the microbiome and oral and systemic health outcomes in postmenopausal women. The cohort was established to examine how the oral microbiome is affected by (and how it affects) periodontal disease presence, severity and progression and to characterise the relationship between the microbiome, lifestyle habits and systemic disease outcomes.

Participants

Participants (n=1342) were postmenopausal women who were participating in the Women’s Health Initiative observational study at the Buffalo, New York clinical centre. There were 1026 participants at the 5-year follow-up visit and 518 at the 15-year visit.

Findings to date

Data collected include questionnaires, anthropometric measures, serum blood and saliva samples. At each clinic visit, participants completed a comprehensive oral examination to measure oral health and the oral microbiome. Preliminary findings have contributed to our understanding of risk factors for periodontal disease and the relationship between the oral microbiome and periodontal disease.

Future plans

The novel microbiome data collected on a large sample of participants at three time points will be used to answer a variety of research questions focused on temporal changes in the microbiome and the relationship between the oral microbiome and oral and systemic disease outcomes. Little is currently known about the relationship between the oral microbiome and health outcomes in older adults; data from the OsteoPerio cohort will fill this gap. Microbiome samples are currently being analysed using next-generation sequencing technology with an anticipated completion date of late 2018.

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