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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.

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.

ObjectivesTo investigate vaccination coverage for influenza and COVID-19 in the SARS-CoV-2 immunity and reinfection evaluation (SIREN) study cohort of healthcare workers (HCWs) between 2020 and 2023 and explore vaccination enablers and barriers.DesignA mixed-methods study nested within SIREN, a multicentre prospective cohort study of HCWs across the UK. Quantitative and qualitative methods were used sequentially, using an expansion/explanation function, enabling emergent themes observed from the quantitative stage to be explored in the qualitative stage.SettingSIREN sites include secondary care centres and community mental health trusts in the UK.ParticipantsQuantitative analysis was conducted on data from 6048 participants. Participants were representative of the HCW workforce, with the majority being women (83%) and of white ethnicity (88%). Nurses made up the largest occupational group (33%). Qualitative analysis of data from 24 participants including five focus groups (n=21) and three semistructured interviews (n=3); 82% women, 26% minority ethnic, all working age from across the UK.Primary outcome measuresQuantitative: vaccine coverage for COVID-19 and influenza vaccines by demographic with multivariable logistical regression used to assess differences. Qualitative: thematic analysis to explore reasons behind the results seen in the quantitative stage.ResultsCOVID-19 vaccination was initially high; 97% received two doses and 94% a first booster. However, coverage was reduced to 77%, for the second booster. Influenza vaccination coverage was lowest in 2020–2021 (46%), increasing to 73% in 2021–2022 and to 79% in 2022–2023. In 2022–2023, vaccination coverage was higher for influenza than for COVID-19. High vaccine coverage for both COVID-19 and influenza was observed in doctors, pharmacists and therapists. Porters, healthcare assistants and staff from minority ethnic groups had lower vaccine coverage for both COVID-19 and influenza. Four themes were identified: (1) attitudes towards vaccination changed throughout the COVID-19 pandemic; (2) HCWs used data to inform vaccination decisions; (3) poor communication in healthcare settings contributed to a reduction in vaccination; (4) there were both positive and negative impacts of the COVID-19 vaccine on influenza vaccine uptake and other vaccination programmes.ConclusionsBetween 2020 and 2023 in our cohort, COVID-19 vaccination coverage decreased, whereas influenza increased. Our study found attitudes to both vaccines have shifted, becoming more favourable to influenza and less to COVID-19 boosters. Barriers to COVID-19 boosters, including concerns about side effects and vaccine effectiveness, need to be addressed with improved communication on the benefits and adverse events. Future vaccination strategies should address the differences we have identified in vaccine coverage across demographics and occupational groups, including continued efforts to improve vaccine equity.Trial registration numberISRCTN11041050.

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.

Background SIREN is a healthcare worker cohort study aiming to determine COVID-19 incidence, duration of immunity and vaccine effectiveness across 135 NHS organisations in four UK nations. Conducting an intensive prospective cohort study during a pandemic was challenging. We designed an evolving retention programme, informed by emerging evidence on best practice. This included applying a multifactorial approach, and considering strategies for barrier reduction, community building, follow-up, and tracing. We utilised participant engagement tools underpinned by our Participant Involvement Panel (PIP) and here we evaluate cohort retention over time and identify learnings. Methods A mixed method evaluation of cohort retention in 12 and 24-month follow-up (June 2020 – March 2023). We described cohort retention by demographics and site, using odds ratios from logistic regression. Withdrawal reasons during this time were collected by survey. We collected participant feedback via cross-sectional online survey conducted October – November 2022, utilising a behavioural science approach. We conducted two focus groups with research teams in February 2023 and conducted thematic analysis exploring cohort retention challenges and facilitators. Results 37,275 (84.7%) participants completed 12-months of follow-up. Of 14,772 participants extending their follow-up to 24 months, 12,635 (85.5%) completed this. Retention increased with age in the 12 (55–64 years vs < 25 years OR = 2.50; 95% CI: 2.19–2.85;  p < 0.001) and 24-month (> 65 years vs < 25 years OR = 2.92; 95% CI: 1.78–4.88;  p < 0.001) cohorts. Retention was highest in the Asian and Black ethnic groups compared to White in the 12 (OR = 1.38; 95% CI: 1.23–1.56; p  < 0.001, and OR = 1.64; 95% CI: 1.30–2.08;  p < 0.001) and 24-month (OR = 1.78; 95% CI: 1.42–2.25; p  < 0.001, and OR = 2.12; 95% CI: 1.41–3.35; p < 0.001) cohort. Among participants withdrawing, the median time in follow-up at withdrawal was 7 months (IQR: 4–10 months) within the 12-month cohort and 19 months within the 24-month cohort (IQR: 16–22 months). The top three reasons for participant withdrawal were workload, leaving site employment and medical reasons. Themes identified from focus-groups included: the need to monitor and understand participant motivation over time, the necessity of inclusive and comprehensive communication, the importance of acknowledging participant contributions, building collaboration with local research teams, and investing in the research team skillset. Conclusion Participant retention in the SIREN study remained high over 24-months of intensive follow-up, demonstrating that large cohort studies are feasible as a pandemic research tool. Our evaluation suggests it is possible to maintain an engaged cohort of healthcare workers (HCWs) during an acute pandemic response phase. The insights gained from this population group are important, as a highly exposed group fulfilling an essential pandemic response and patient care function. The success of the cohort study overall, as well as the specific population group retained, offer useful insight for pandemic preparedness planning and healthcare worker studies.

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.

Drug-resistant infections caused by bacteria with increasing antimicrobial resistance (AMR) threaten our ability to treat life-threatening conditions. Tackling AMR requires international collaboration and partnership. An early and leading priority to do this is to strengthen AMR surveillance, particularly in low-income countries where the burden of infectious diseases is highest and where data are most limited. The World Health Organization (WHO) has developed the Global AMR Surveillance System (GLASS) as one of a number of measures designed to tackle the problem of AMR, and WHO member states have been encouraged to produce National Action Plans for AMR by 2017. However, low-income countries are unlikely to have the resources or capacity to implement all the components in the GLASS manual. To facilitate their efforts, we developed a guideline that is aligned to the GLASS procedures, but written specifically for implementation in low-income countries. The guideline allows for flexibility across different systems, but has sufficient standardisation of core protocols to ensure that, if followed, data will be valid and comparable. This will ensure that the surveillance programme can provide health intelligence data to inform evidence-based interventions at local, national and international levels.

Even in the absence of symptoms, adhere to legislation and guidance regarding measures to reduce the risk of transmission of SARS-CoV-2 (such as social distancing, hand hygiene, use of personal protective equipment and ventilation of enclosed spaces). The recommendations based on the evidence we have reviewed give confidence that the things we are all doing such as social distancing, hand washing, wearing face coverings and keeping rooms well ventilated by opening windows are the things that we should be doing to prevent people getting infected with Covid-19. Understanding the risk of transmission according to the index case’s symptom status at the time of exposure of (and potential transmission to) their close contacts is important to allow healthcare workers and the public to take action to protect themselves and others. The main purpose of the recommendations is to inform clinicians, managers and policy makers about SARS-CoV-2 transmission dynamics and to provide evidence-based guidance to prevent and control the spread of SARS-CoV-2 in health and care settings.

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.

Background Participant involvement in research studies is not a new concept, yet barriers to implementation remain and application varies. This is particularly true for pandemic response research studies, where timeframes are condensed, pressure is high and the value and inclusion of participant involvement can be overlooked. The SIREN Participant Involvement Panel (PIP) provides a case study for participant involvement in pandemic research, working in partnership with people who the research is for and about. Methods SIREN and the British Society for Immunology (BSI) recruited and ran two phases of the PIP, involving 15 members in total over a 16-month period. Phase 1 ran between January and August 2022 and Phase 2 between October 2022 and March 2023. Activity figures including recruitment interest and PIP meeting attendance were recorded. To evaluate how the PIP has influenced SIREN, feedback was collected from (a) researchers presenting at the PIP and (b) PIP members themselves. Evaluation at the end of Phase 1 informed our approach to Phase 2. Thematic grouping was planned to identify key lessons learned. Results Applications increased from n = 30 to n = 485 between Phase 1 and Phase 2 of the PIP, a more than 15-fold increase. The SIREN PIP positively impacted the design, implementation and evaluation phases of the study and sub-studies. Feedback from PIP members themselves was positive, with members highlighting that they found the role rewarding and felt valued. Learnings from the PIP have been condensed into five key themes for applying to future pandemic response research studies: the importance of dedicated resources; recruiting the right panel; understanding motivations for participant involvement; providing flexible options for involvement and enabling the early involvement of participants. Conclusions The SIREN PIP has demonstrated the value of actively involving people who research is for and about. The PIP has provided an active feedback mechanism for research and demonstrated a positive influence on both SIREN study researchers and PIP members themselves. This paper makes the case for participant involvement in future pandemic research studies. Future work should include improved training for researchers and we would support the development of a national PIP forum as part of future pandemic research preparedness. Plain English summary The SARS-Cov2 Immunity & Reinfection Evaluation (SIREN) study was set-up at speed during the early stages of the pandemic to help answer key questions about COVID-19 and inform the national pandemic response. It has provided valuable insight into COVID-19 infections, reinfections, and how well the vaccines work. SIREN helped to find these answers by regularly testing over 44,000 healthcare staff working at 135 NHS organisations. To support participant retention, SIREN established a Participant Involvement Panel (PIP) involving 15 SIREN participants to date. PIP members provide guidance and feedback to SIREN researchers on key research priorities, changes to the study and strategies for maximising participant engagement. This paper provides insight into how the PIP was set-up, run and the resources required from the perspective of the PIP and SIREN researchers. Lessons learned from establishing the PIP are summarised to help inform future pandemic response research studies. The paper adds to the evidence base, and makes the case for, the valuable role participant involvement can play in pandemic response research studies.