Search

Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines. Methods We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria—with no contraindications to influenza vaccination—were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18–64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995. Findings Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to

This article describes how research to understand the oral care needs and experiences of stroke survivors was translated into a prototypical intervention. It addresses the challenge of how to develop service improvements in healthcare settings that are both person-centred, through the use of co-design, and also based on theory and evidence.A sequence of co-design workshops with stroke survivors, family carers and with health and social care professionals, ran in parallel with an analysis of behavioural factors. This determined key actions which could improve mouthcare for this community and identified opportunities to integrate recognised behaviour-change techniques into the intervention. In this way, behaviour change theory, evidence from qualitative research and experience-based co-design were effectively combined. The intervention proposed is predominantly a patient-facing resource, intended to support stroke-survivors and their carers with mouth care, as they transition from hospital care to living at home. This addresses a gap in existing provision, as other published oral-care protocols for stroke are clinician-facing and concerned primarily with acute care (in the first days after a stroke).Although it draws on the experiences of a single design project, this study articulates a ‘working relationship’ between design practice methods and the application of behaviour change theory. Keywords: co-design, behaviour change, stroke care, oral-care, person-centred care, EBCD, experience based co-design.

Background: Dental disease is highly prevalent in people with stroke. Stroke survivors regard oral hygiene as an important, yet neglected, area. The aim was to explore experiences of and barriers to oral care, particularly in relation to oral hygiene practice and dental attendance, among stroke survivors in the community. Methods: This was a qualitative study incorporating a critical realist approach. Interviews were conducted with community-dwelling stroke survivors requiring assistance with activities of daily living, and focus groups were held with health and care professionals. Interviews and focus groups were recorded and transcribed verbatim. Thematic analysis was conducted. Results: Twenty-three stroke survivors were interviewed, and 19 professionals took part in 3 focus groups. Professionals included nurses, speech and language therapists, occupational therapists, dieticians, professional carers and dental staff. Interviews revealed difficulties in carrying out oral hygiene self-care due to fatigue, forgetfulness and limb function and dexterity problems. Routine was considered important for oral hygiene self-care and was disrupted by hospitalization resulting from stroke. Professionals highlighted gaps in staff training and confidence in supporting patients with oral care. Access to dental services appeared particularly problematic for those who were not registered with a dentist pre-stroke. Conclusion: Oral hygiene routines may be disrupted by stroke, and resulting disabilities may make regular oral self-care more difficult. This study has identified specific barriers to oral hygiene self-care and dental service access. Findings from this study are feeding into the development of an intervention to support stroke survivors with oral care.