Comparative effectiveness of two- and three-dose schedules involving AZD1222 and BNT162b2 in people with kidney disease: a linked OpenSAFELY and UK Renal Registry cohort study

Parker, Edward P K; Horne, Elsie; Hulme, William; Tazare, John; Zheng, Bang; Carr, Edward J; Loud, Fiona; Lyon, Susan; Mahalingasivam, Viyaasan; MacKenna, Brian; Mehrkar, Amir; Scanlon, Miranda; Santhakumaran, Shalini; Steenkamp, Retha; Goldacre, Ben; Sterne, Jonathan A C; Nitsch, Dorothea; Tomlinson, Laurie

doi:10.1101/2022.11.16.22282396

Cited by 5 publications

(6 citation statements)

References 23 publications

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“…This is emphasised by our finding that breadth of neutralisation (Fab function and potentially diversity) and complement binding (Fc function) are not mutually inclusive in patients requiring HD, but are influenced by the vaccine platform used. Boosting with a third mRV dose resulted in equivalent humoral responses in HD patients, independent of the vaccine type received previously, similar to what has been observed by others [51]. Again, this emphasises the importance of the maturation of antibody responses, presumably through further germinal centre induction, but may also indicate either that heterologous vaccination protocols can be beneficial in their own right or that mRNA vaccines offer some superiority in the HD population [24].…”

Section: Discussionsupporting

confidence: 82%

Different vaccine platforms result in distinct antibody responses to the same antigen in haemodialysis patients

Wall,

Lamerton,

Ashford

et al. 2024

Preprint

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Generalised immune dysfunction in chronic kidney disease, especially in patients requiring haemodialysis (HD), significantly enhances the risk of severe infections. Moreover, vaccine-induced immunity is typically reduced in HD populations, but the full mechanisms behind this remain unclear. The SARS-CoV-2 pandemic provided an opportunity to examine the magnitude and functionality of antibody responses in HD patients to a previously unencountered antigen, Spike (S)-glycoprotein, after vaccination with different vaccine platforms (viral vector (VV); mRNA (mRV)). Here, we compared total and functional anti-S antibody responses (cross-variant neutralisation and complement binding) in 187 HD patients and 43 healthy controls 21-28 days after serial immunisation. After 2 doses of the same vaccine, HD patients had anti-S antibody levels and complement binding capacity comparable to controls. However, 2 doses of mRV induced greater polyfunctional antibody responses than VV, yet previous SARS-CoV-2 infection or an mRV boost after 2 doses of VV significantly enhanced antibody functionality in HD patients. Therefore, HD patients can generate near-normal, functional antigen-specific antibody responses following serial vaccination to a novel antigen, suggesting largely intact B cell memory. Encouragingly, exploiting immunological memory by using mRNA vaccines and boosting may improve the success of vaccination strategies in this vulnerable patient population.

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Section: Discussionsupporting

confidence: 82%

Different vaccine platforms result in distinct antibody responses to the same antigen in haemodialysis patients

Wall,

Lamerton,

Ashford

et al. 2024

Preprint

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“…All codelists used to define conditions and variables are openly available online at www.OpenCodelists.org for inspection and re-use. Definitions used in this study reuse codelists developed for published studies (27,38,44,45).…”

Section: Methodsmentioning

confidence: 99%

“…To ensure our cohort produced results consistent with previous literature, we included a control outcome for which we knew the expected direction of effect estimates. We used hospitalisation with COVID-19 ( Supplementary Methods) which should have a negative association with SARS-CoV-2 vaccination based on previous research (38,39). To account for the gap between SARS-CoV-2 infection and the recording of long COVID, we only analysed COVID-19 test results and hospitalisations >12 weeks before the end of follow up.…”

Section: Methodsmentioning

confidence: 99%

Clinical coding of long COVID in primary care 2020-2023 in a cohort of 19 million adults: an OpenSAFELY analysis

Henderson,

Butler-Cole,

Tazare

et al. 2023

Preprint

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BackgroundLong COVID is the patient-coined term for the persistent symptoms of COVID-19 illness for weeks, months or years following the acute infection. There is a large burden of long COVID globally from self-reported data, but the epidemiology, causes and treatments remain poorly understood. Primary care is used to help identify and treat patients with long COVID and therefore Electronic Health Records (EHRs) of past COVID-19 patients could be used to help fill these knowledge gaps. We aimed to describe those with long COVID in primary care records in England.MethodsWith the approval of NHS England we used routine clinical data from over 19 million adults in England linked to SARS-COV-2 test result, hospitalisation and vaccination data to describe trends in the recording of 16 clinical codes related to long COVID between November 2020 and January 2023. We calculated rates per 100,000 person-years and plotted how these changed over time. We compared crude and minimally adjusted rates of recorded long COVID in patient records between different key demographic and vaccination characteristics using negative binomial models.FindingsWe identified a total of 55,465 people recorded to have long COVID over the study period, with incidence of new long COVID records increasing steadily over 2021, and declining over 2022. The overall rate per 100,000 person-years was 177.5 cases in women (95% CI: 175.5-179) and 100.5 men (99.5-102). In terms of vaccination against COVID-19, the lowest rates were observed in those with 3+ vaccine doses (103.5 [95% CI: 101.5-105]). Finally, the majority of those with a long COVID record did not have a recorded positive SARS-COV-2 test 12 weeks before the long COVID record.InterpretationEHR recorded long COVID remains very low compared and incident records of long COVID declined over 2022. We found the lowest rates of recorded long COVID in people with 3 or more vaccine doses. We summarised several sources of possible bias for researchers using EHRs to study long COVID.

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“…Electronic health records (EHRs) are a valuable research tool to better understand the impact of health conditions. They have contributed to better understanding of COVID-19 fatalities (7,8), infection risk (9,10), the effectiveness of treatments (11,12) and vaccinations (13)(14)(15). However, long COVID in EHRs is poorly captured (16), and even in those that have a record this binary categorisation does not reflect the variety of experiences in those with long COVID, which may be better captured by patient-reported outcomes.…”

Section: Why Was the Cohort Set Up?mentioning

confidence: 99%

Cohort profile: OpenPROMPT

Henderson,

Carlile,

Dillingham

et al. 2023

Preprint

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OpenPROMPT is a cohort of individuals with longitudinal patient reported questionnaire data and linked to routinely collected health data from primary and secondary care. Data were collected between November 2022 and October 2023 in England. OpenPROMPT was designed to measure the impact of long COVID on health-related quality-of-life (HRQoL). With the approval of NHS England we collected responses from 7,574 individuals, with detailed questionnaire responses from 6,337 individuals who responded using a smartphone app. Data were collected from each participant over 90 days at 30-day intervals using questionnaires to ask about HRQoL, productivity and symptoms of long COVID. Responses from the majority of OpenPROMPT (6,006; 79.3%) were linked to participants’ existing health records from primary care, secondary care, COVID-19 testing and vaccination data. Analysis takes place using the OpenSAFELY data analysis platform which provides a secure software interface allowing the analysis of pseudonymized primary care patient records from England. OpenPROMPT can currently be used to estimate the impact of long COVID on HRQoL, and because of the linkage within OpenSAFELY, the data from OpenPROMPT can be used to enrich routinely collected records in further research by approved researchers on behalf of NHS England.Lay summaryOpenPROMPT is a study which used a phone app to conduct a longitudinal survey aimed at measuring the health related quality of life of people living with long COVID. The study recruited participants between November 2022 and July 2023 and followed them up for 90 days. The key advantage of this study is that the responses are linked to the individual’s personal health records, so we have access to much more data than the questionnaire responses alone.Here, we summarised who has used the app, how much data has been collected and the quality of the data. We also provide details to document how and why the data were collected so that the data can be used by other researchers in the future. This will maximise the benefit of this study, and ensure that the time invested by participants is put to best use.In this study we aimed to provide lots of important information about how many people are involved, how much information we have about them, their age, where they live, and how healthy they are. Finally, for certain variables we compared the responses people recorded in the app with what is kept on their electronic record to see if they agree or disagree.Key featuresOpenPROMPT is a cohort of individuals with longitudinal patient reported questionnaire data and linked to routinely collected health data from primary and secondary care.With the approval of NHS England we collected responses from 7,574 individuals, with detailed questionnaire responses from 6,337 individuals who responded using a smartphone app.Data were collected from each participant over 90 days at 30-day intervals using questionnaires to ask about HRQoL, productivity and symptoms of long COVID.Responses from the majority of OpenPROMPT (6,006; 79.3%) were linked to participants’ existing health records from primary care, secondary care, COVID-19 testing and vaccination data.OpenPROMPT can currently be used to estimate the impact of long COVID on HRQoL, and because of the linkage within OpenSAFELY, the data from OpenPROMPT can be used to enrich routinely collected records in further research by approved researchers on behalf of NHS England.

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Comparative effectiveness of two- and three-dose schedules involving AZD1222 and BNT162b2 in people with kidney disease: a linked OpenSAFELY and UK Renal Registry cohort study

Cited by 5 publications

References 23 publications

Different vaccine platforms result in distinct antibody responses to the same antigen in haemodialysis patients

Different vaccine platforms result in distinct antibody responses to the same antigen in haemodialysis patients

Clinical coding of long COVID in primary care 2020-2023 in a cohort of 19 million adults: an OpenSAFELY analysis

Cohort profile: OpenPROMPT

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