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In winter 2022, SIREN, a prospective healthcare worker cohort study monitoring SARS-CoV-2, ran a pilot sub-study introducing multiplex PCR testing for SARS-CoV-2, influenza, and RSV to investigate winter pressures. Three pathways were trialled: (A) on-site (at hospital) swabbing for PCR testing, using the local laboratory for testing, (B) on-site swabbing using a UKHSA-commissioned laboratory for testing, and (C) postal swabbing using a UKHSA-commissioned laboratory for testing. Here, we compare pathways in relation to recruitment, testing coverage, participant acceptability, and UKHSA SIREN research team feedback. A mixed methods evaluation using metrics of quality assurance and study fidelity (participant recruitment and retention; multiplex PCR testing timing and coverage), an adapted NIHR 'participant in research' feedback questionnaire, and thematic analysis of a UKHSA SIREN research team workshop. With 7,774 participants recruited, target recruitment (N = 7,500) was achieved. Thirty-nine sites took part in the sub-study (4,289 participants). Thirty-three used pathway A (3,713 participants), and six used pathway B (576 participants). 3,485 participants were enrolled into pathway C (27.8% of invitees). The median number of tests per participant was similar across pathways (6; 4; 5). However, sites using local laboratories showed a wide variation in the date they switched to multiplex testing (28th November 2022-16th March 2023). Consequently, influenza and RSV testing coverage was higher for pathways using UKHSA-commissioned laboratories (100.0% vs 45.6% at local laboratories). 1,204/7,774 (15.5%) participants completed the feedback survey. All pathways were acceptable to participants; 98.9% of postal and 97.5% of site-based participants 'would consider taking part again'. Transitioning SARS-CoV-2 PCR testing to include influenza and RSV was challenging to achieve rapidly across multiple sites. The postal testing pathway proved more agile, and UKHSA-commissioned laboratory testing provided more comprehensive data collection than local laboratory testing. This sub-study indicates that postal protocols are effective, adaptable at pace, and acceptable to participants.

Background Delivering research studies that require a large number of samples to monitor specific populations is complex, often resulting in high costs and intricate logistics. We aim to describe the processes for blood sample collection and management and evaluate alternative sampling methods within a large cohort of healthcare workers in the UK (the SIREN study). Methods We conducted a process evaluation. First, we described blood sample collection and management across different study periods from June 2020 to March 2024 and how these evolved over time. Secondly, we compared alternative methods of blood sampling: venous phlebotomy (hospital-based) vs. capillary sampling (at-home). Results The main challenges with blood sampling within SIREN stemmed from the scale and use of decentralised phlebotomy across 135 hospital sites during the COVID-19 pandemic. We adapted our sampling processes as the study progressed, overcoming most of these challenges. When comparing hospital-based and at-home sampling, overall, return rates of samples taken at home were higher than site- based samples (80% vs 71%, respectively). At-home samples took less time to be returned to UKHSA Laboratory for testing compared to hospital-based samples (median 2 days; interquartile (IQ) 2–3) vs 6 days; IQ 3–8). However, at-home samples were more likely to be considered void (4%) when tested compared to hospital-based samples (0%). Cost for hospital-based sampling was almost 3-times higher than at-home sampling (£34.05 vs £11.50, respectively), although larger sample volumes were obtained via hospital-based sampling when compared to at-home sampling (8 ml vs 600 µl of whole blood). Conclusions Sample collection and management in large scale research studies are complex. Our results support at-home blood sampling as an effective and cheaper strategy when compared to hospital-based phlebotomy and therefore should be considered as alternative sampling method for future research. Trial registration number ISRCTN11041050—registration date 12/01/2021.

IntroductionUnderstanding the effectiveness and durability of protection against SARS-CoV-2 infection conferred by previous infection and COVID-19 is essential to inform ongoing management of the pandemic. This study aims to determine whether prior SARS-CoV-2 infection or COVID-19 vaccination in healthcare workers protects against future infection.Methods and analysisThis is a prospective cohort study design in staff members working in hospitals in the UK. At enrolment, participants are allocated into cohorts, positive or naïve, dependent on their prior SARS-CoV-2 infection status, as measured by standardised SARS-CoV-2 antibody testing on all baseline serum samples and previous SARS-CoV-2 test results. Participants undergo monthly antibody testing and fortnightly viral RNA testing during follow-up and based on these results may move between cohorts. Any results from testing undertaken for other reasons (eg, symptoms, contact tracing) or prior to study entry will also be captured. Individuals complete enrolment and fortnightly questionnaires on exposures, symptoms and vaccination. Follow-up is 12 months from study entry, with an option to extend follow-up to 24 months.The primary outcome of interest is infection with SARS-CoV-2 after previous SARS-CoV-2 infection or COVID-19 vaccination during the study period. Secondary outcomes include incidence and prevalence (both RNA and antibody) of SARS-CoV-2, viral genomics, viral culture, symptom history and antibody/neutralising antibody titres.Ethics and disseminationThe study was approved by the Berkshire Research Ethics Committee, Health Research Authority (IRAS ID 284460, REC reference 20/SC/0230) on 22 May 2020; the vaccine amendment was approved on 12 January 2021. Participants gave informed consent before taking part in the study.Regular reports to national and international expert advisory groups and peer-reviewed publications ensure timely dissemination of findings to inform decision making.Trial registration numberISRCTN11041050.

Engaging and retaining research participants in studies that require sampling (e.g., blood, sputum) can be challenging. Regularly contributing biological sampling can be demanding for healthcare workers (HCW) in particular. SIREN is a prospective cohort of HCW in the UK who have been carrying out COVID‐19 testing since 2020. We aimed to evaluate satisfaction with at‐home PCR and blood sampling by collecting SIREN participants' feedback regarding sampling processes for COVID‐19 testing. We explored the acceptability of at‐home (PCR swab and finger‐prick blood sampling) compared to at‐hospital (PCR swab and phlebotomy) sampling. Thematic analysis was used to code free‐text responses. Out of 2,816 respondents, 74% preferred PCR testing at home compared to on site. Half of 1,279 participants who returned blood samples using a postal kit preferred to complete serological sampling at home instead of in hospital (52%). One in five reported no preference. Participants valued the ease and convenience of home‐sampling and clear communication about instructions and test results. Some participants reported difficulties with blood collection or logistic issues related to kits, but this did not prevent them from returning samples nor deter them from undergoing sampling in future research. Home‐sampling for PCR and serological testing was acceptable and feasible in this HCW cohort. Self‐sampling can be a cost‐effective and efficient way of collecting participant data. Clear communications about instructions for sample collection and the purpose of capturing the sample, easy‐to‐use devices and ensuring participants feel valued are strong facilitators to high uptake, and on‐going study retention.

Among more than 35,000 health care workers, those who received two doses of BNT162b2 vaccine had a high level of protection against Covid-19, regardless of the between-dose interval, but efficacy began to wane after 6 months. Immunity in vaccinated, previously infected persons was more effective and durable (>1 year) than that in vaccinated persons who had not been infected.

Seasonal vaccination of healthcare workers (HCWs) against COVID-19 and influenza has been recommended to protect patients and the workforce against Winter pressures. We aimed to investigate demographic, occupational, accessibility and tolerability factors associated with COVID-19 and influenza vaccination among HCWs within the SIREN study cohort in 2023/24. We conducted a cross-sectional survey between 29 February-22 March 2024 within SIREN, a prospective HCW cohort across the UK. Adjusted odds ratios (aOR) and 95 % confidence intervals (CI) from a multivariable regression analysis were used to identify factors associated with vaccination. Proportions were calculated to describe the rationale for receiving/not receiving seasonal vaccines. A total of 5357/33,007 (16.2 %) SIREN participants completed the survey. 66.7 % (3572/5357) received both vaccines, 2.4 % (129/5357) COVID-19 only, 12.4 % (662/5357) influenza only, and 18.3 % (979/5357) neither. Participants were more likely to receive any vaccine if they were over 65 years (aOR 2.73, 95 % CI: 1.64–4.55), a doctor (aOR 2.28, 95 % CI: 1.70–3.05) or had a chronic respiratory condition (aOR 1.52, 95 % CI: 1.20–1.92). Participants of Black ethnicity were less likely to be vaccinated (aOR 0.42, 95 % CI: 0.27–0.66). The top reason for vaccination was to protect oneself (81.6 %). Concern about long-term side effects was the main reason for not getting vaccinated among those who did not receive the COVID-19 vaccine (30.1 %). We observed differences in uptake and attitudes towards seasonal vaccines among UK HCWs within the SIREN cohort. Differences in demographic characteristics, occupation and attitudes varied by vaccine type and this should be considered when planning seasonal vaccination programmes to protect the health workforce. •The decision to receive a vaccine varied by age, occupation and ethnicity.•Vaccination uptake was higher for the seasonal influenza vaccine than the COVID-19 vaccine.•The top reason for vaccination was to protect oneself.•The main enablers for vaccination related to ease of access and convenience.•Concerns about long-term side effects was the main barrier for vaccination.

SARS-CoV-2 immune escape variants can alter existing vaccine effectiveness. In September 2023, we aimed to predict the neutralising response against BA.2.86 offered by XBB-lineage vaccines before vaccine roll-out utilising XBB.1.5 convalescent sera. We then assessed the response to XBB-lineage boosters from different individuals in the same cohort. A total of 78 sera samples (pre/post-XBB.1.5 infection and pre/post-XBB-lineage vaccination) were tested for live microneutralisation against SARS-CoV-2 Victoria and Omicron subvariants. Geometric means (GM) of neutralising antibody titres (nAbT) pre- and post-infection/vaccination were compared. After XBB.1.5 infection, a 4-fold increase in neutralising antibody titres against BA.2.86 was observed compared to pre-infection titres (GM 51 vs 210, p ≤ 0.0001). A similar increase in BA.2.86 nAbT was seen post-XBB-lineage vaccination (GM 144 vs 600, fold change = 4.17, p ≤ 0.0001). XBB.1.5 infection was a suitable proxy to predict the neutralisation response following XBB-lineage vaccination. Our findings may support future vaccine development and vaccination strategies.

The combination of patient illness and staff absence driven by seasonal viruses culminates in annual \"winter pressures\" on UK healthcare systems and has been exacerbated by COVID-19. In winter 2022/23 we introduce multiplex testing aiming to determine the incidence of SARS-CoV-2, influenza and respiratory syncytial virus (RSV) in our cohort of UK healthcare workers (HCWs). The pilot study was conducted from 28/11/2022-31/03/2023 within the SIREN prospective cohort study. Participants completed fortnightly questionnaires, capturing symptoms and sick leave, and multiplex PCR testing for SARS-CoV-2, influenza and RSV, regardless of symptoms. PCR-positivity rates by virus were calculated over time, and viruses were compared by symptoms and severity. Self-reported symptoms and associated sick leave were described. Sick leave rates were compared by vaccination status and demographics. 5,863 participants were included, 84.6% female, 70.3% ≥ 45-years, 91.4% of White ethnicity and 82.6% in a patient facing role. PCR-positivity peaked in early December for all three viruses (4.6 positives per 100 tests (95%CI 3.5, 5.7) SARS-CoV-2, 3.9 (95%CI 2.2, 5.6) influenza, 1.4 (95%CI 0.4, 2.4) RSV), declining to <0.3/100 tests after January for influenza/RSV, and around 2.5/100 tests for SARS-CoV-2. Over one-third of all infections were asymptomatic, and symptoms were similar for all viruses. 1,368 (23.3%) participants reported taking sick leave, median 4 days (range 1-59). Rates of sick leave were higher in participants with co-morbidities, working in clinical settings, and who had not been vaccinated (COVID-19 booster or seasonal influenza vaccine) versus those who had received neither vaccine (2.04 vs 1.41 sick days/100 days, adjusted Incidence Rate Ratio 1.47 (95%CI 1.38, 1.56). This pilot demonstrated the use of multiplex testing allowed better understanding of the impact of seasonal respiratory viruses and respective vaccines on the HCW workforce. This highlights the important information on asymptomatic infection and persisting levels of SARS-CoV-2 infection.

Since June 2020, the SARS-CoV-2 Immunity and Reinfection Evaluation (SIREN) study has conducted routine PCR testing in UK healthcare workers and sequenced PCR-positive samples. SIREN detected increases in infections and reinfections and delected Omicron subvariant waves emergence contemporaneous with national surveillance. SIREN's sentinel surveillance methods can be used for variant surveillance.