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DELSY project: status and development.

N Balalykin·P Beloshitsky·V Bykovsky·V Kobets·V Kolobanov·G Kulipanov·E Levichev·V Mikhaylin·I Meshkov·N Mezentsev·N Morozov·I Seleznev·G Sidorov·A Skrinsky·G Shirkov·E Syresin·I Titkova·M Yurkov
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Abstract

The DELSY (Dubna Electron Synchrotron) project is under development at the Joint Institute for Nuclear Research [Arkhipov et al. (2001). Nucl. Instrum. Methods, A467, 57-62; Arkhipov et al. (2001). Nucl. Instrum. Methods, A470, 1-6; Titkova et al. (2000). Proceedings of the Seventh European Particle Accelerator Conference, pp. 702-704]. It is based on an acceleration facility donated to the Joint Institute for Nuclear Research by the Institute for Nuclear and High Energy Physics (NIKHEF, Amsterdam). The NIKHEF accelerator facility consists of the linear electron accelerator MEA, which has an electron energy of 700 MeV, and the electron storage ring AmPS, with a maximum energy of 900 MeV and a beam current of 200 mA. There are three phases to the construction of the DELSY facility. Phase I will be accomplished with the construction of a complex of free-electron lasers covering continuously the spectrum from the far infrared down to the ultraviolet ( approximately 150 nm). Phase II will be accomplished with the commissioning of the storage ring DELSY. Complete commissioning of the DELSY project will take place after finishing Phase III, the construction of an X-ray free-electron laser. This phase is considered as the ultimate goal of the project; it is currently under development and is not described in this paper.

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N Balalykin, P Beloshitsky, V Bykovsky, V Kobets, V Kolobanov, G Kulipanov, E Levichev, V Mikhaylin, I Meshkov, N Mezentsev, N Morozov, I Seleznev, G Sidorov, A Skrinsky, G Shirkov, E Syresin, I Titkova, M Yurkov. 2003-08-28. DELSY project: status and development.. https://doi.org/10.1107/s0909049503011117

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Effectiveness of high-dose versus standard-dose influenza vaccines against hospitalisation according to frailty risk: a prespecified analysis of the randomised trial DANFLU-2.

BACKGROUND: Frailty is a major risk factor for influenza-related complications and can influence vaccine effectiveness. We aimed to assess the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) versus standard-dose inactivated influenza vaccine (SD-IIV) in older adults aged 65 years or older according to frailty risk. METHODS: This study was a prespecified analysis of DANFLU-2, an open-label, individually randomised trial, conducted in Denmark during three consecutive influenza seasons (2022-23, 2023-24, and 2024-25). Adults aged 65 years or older were randomised (1:1) to the HD-IIV or SD-IIV group. The primary endpoint was hospitalisation for influenza or pneumonia. Frailty was defined according to the validated Hospital Frailty Risk Score (HFRS) based on ICD-10 codes within 10 years before randomisation. Participants were stratified into three HFRS categories, namely low (<5 points), intermediate (5-15 points), and high (>15 points) frailty risk. The rVE of HD-IIV versus SD-IIV against the primary endpoint was assessed across prespecified HFRS categories and treating HFRS as a continuous variable. Pearson's chi-square test was used to compare safety events across frailty risk groups and randomisation groups. FINDINGS: Among 332&#x2009;438 randomised participants (mean age 73&#xb7;7 years [SD 5&#xb7;8]; 161&#x2009;538 [48&#xb7;6%] were female), 276&#x2009;173 (83&#xb7;1%) had low frailty risk, 52&#x2009;395 (15&#xb7;8%) had intermediate frailty risk, and 3861 (1&#xb7;2%) had high frailty risk. The primary endpoint of hospitalisation for influenza or pneumonia occurred in 1424 (0&#xb7;5%) of 276&#x2009;173 participants with low frailty risk, 761 (1&#xb7;5%) of 52&#x2009;395 with intermediate frailty risk, and 163 (4&#xb7;2%) of 3861 with high frailty risk (relative risk [RR] for intermediate vs low frailty risk 2&#xb7;8 [95% CI 2&#xb7;6-3&#xb7;1]; RR for high vs low frailty risk 8&#xb7;2 [7&#xb7;0-9&#xb7;6]). HFRS as a continuous variable significantly modified the effect of HD-IIV versus SD-IIV against the primary endpoint with higher rVE estimates with increasing HFRS (pinteraction=0&#xb7;020). The rVE was 0&#xb7;2% (95% CI -10&#xb7;8 to 10&#xb7;2) among those with low frailty risk, 13&#xb7;1% (-0&#xb7;4 to 24&#xb7;8) among those with intermediate frailty risk, and 19&#xb7;9% (-10&#xb7;3 to 42&#xb7;1) among those with high frailty risk. No significant interaction was observed when HFRS was assessed according to the prespecified categorical frailty groups (pinteraction=0&#xb7;17). The proportion of participants with at least one serious adverse event increased across frailty risk groups (13&#x2009;366 [4&#xb7;8%] of 275&#x2009;795 for low frailty risk, 5475 [10&#xb7;5%] of 52&#x2009;315 for intermediate frailty risk, and 777 [20&#xb7;2%] of 3850 for high frailty risk; p<0&#xb7;0001), with similar proportions of serious adverse events in the HD-IIV and SD-IIV groups for each frailty risk group. INTERPRETATION: Among adults aged 65 years or older in Denmark, frailty risk might modify the effects of HD-IIV versus SD-IIV against hospitalisation for influenza or pneumonia, with higher rVE estimates with increasing frailty risk. These findings might support considering high-dose influenza vaccines for frail older adults. However, effect modification was not evident when frailty was assessed using prespecified categorical subgroups, and subgroup-specific estimates were imprecise, with 95% CIs crossing the null. These results should be considered exploratory, warranting further investigation. FUNDING: The DANFLU-2 trial was funded by Sanofi.

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