Percorrer por autor "Savulescu, Camelia"
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- Effectiveness of long-acting monoclonal antibodies against laboratory-confirmed RSV in children aged < 24 months and hospitalised for severe acute respiratory infection, European pilot study, 2024 to 2025Publication . Savulescu, Camelia; Ganser, Iris; Nicolay, Nathalie; Lajot, Adrien; Campos, Sandra; Martínez-Baz, Iván; Rodrigues, Ana Paula; Vandromme, Mathil; Cara-Rodríguez, Marta; Echeverría, Aitziber; Gaio, Vânia; Parsy, Marie-Pierre; Garrido, Ana Roldan; Castilla, Jesús; Guiomar, Raquel; Bacci, Sabrina; Rose, Angela Mc; VEBIS hospital network RSV IE groupWe measured effectiveness of nirsevimab against laboratory-confirmed respiratory syncytial virus (RSV) infection in a test-negative case-control study among children aged < 24 months hospitalised for severe acute respiratory infection in three European countries. The overall effectiveness in the 2024/25 season among 2,201 children was 79% (95% CI: 58 to 89) and 85%, 78% and 69% at < 30, 30-89 and 90-215 days since immunisation. Immunisation was effective for preventing RSV-related hospitalisation in children, but effectiveness by time since immunisation needs monitoring in future seasons.
- Effectiveness of the autumn 2023 COVID-19 vaccine dose in hospital-based healthcare workers: results of the VEBIS healthcare worker vaccine effectiveness cohort study, seven European countries, season 2023/24Publication . Savulescu, Camelia; Prats-Uribe, Albert; Brolin, Kim; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Murri, Rita; Zvirbulis, Viesturs; Zavadska, Dace; Gaio, Vania; Popescu, Corneliu P.; Hrisca, Raluca; Cisneros, Maria; Latorre-Millán, Miriam; Lohur, Liis; McGrath, Jonathan; Ferguson, Lauren; De Gaetano Donati, Katleen; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin-Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa Cuesta, Laura; Sui, Jacklyn; Kenny, Claire; Santangelo, Rosaria; Krievins, Dainis; Barzdina, Elza Anna; Valadas Henriques, Camila; Kosa, Alma Gabriela; Pohrib, Saftica-Mariana; Muñoz-Almagro, Carmen; Milagro, Ana; Bacci, Sabrina; Nardone, Anthony; VEBIS HCW VE study group; Collaborators in VEBIS HCW study groupCOVID-19 vaccination recommendations prioritise healthcare workers (HCWs), considering their exposure to severe acute respiratory coronavirus 2 (SARS-CoV-2) and their key role in the functioning of healthcare systems. In the European Union/European Economic Area (EU/EEA), HCWs were considered a priority for COVID-19 revaccination during the autumn 2023 campaign [1], and the World Health Organization (WHO) recommended revaccination of HCWs 12 months after their last dose [2]. Because the Omicron sub-lineage XBB.1.5 predominated in spring 2023, the COVID-19 vaccines were adapted to target this emerging strain, and the first XBB.1.5 vaccine was authorised for use in the EU/EEA in August 2023. Omicron BA.2.86/JN.1 emerged in the EU/EEA at the end of 2023, according to data available on the European Respiratory Virus Surveillance Summary (ERVISS) [3]. Evidence for COVID-19 vaccine recommendation in the HCW population remains scarce. Within the Vaccine Effectiveness, Burden and Impact (VEBIS) project, we aimed to measure the COVID-19 vaccine effectiveness (CVE) in HCWs, in the winter season 2023/24.
- Estimates of pandemic influenza vaccine effectiveness in Europe, 2009-2010: results of Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE) multicentre case-control studyPublication . Valenciano, Marta; Kissling, Esther; Cohen, Jean-Marie; Oroszi, Beatrix; Barret, Anne-Sophie; Rizzo, Caterina; Nunes, Baltazar; Pitigoi, Daniela; Larrauri Cámara, Amparro; Mosnier, Anne; Horvath, Judith K.; O'Donnell, Joan; Bella, Antonino; Guiomar, Raquel; Lupulescu, Emilia; Savulescu, Camelia; Ciancio, Bruno C.; Kramarz, Piotr; Moren, AlainA multicentre case-control study based on sentinel practitioner surveillance networks from seven European countries was undertaken to estimate the effectiveness of 2009-2010 pandemic and seasonal influenza vaccines against medically attended influenza-like illness (ILI) laboratory-confirmed as pandemic influenza A (H1N1) (pH1N1).
- Hybrid, infection‑ and vaccination‑induced protection against laboratory‑ confirmed SARS‑CoV‑2 infection in a European multi‑centre prospective cohort of healthcare workers, 2021–2024Publication . Rojas‑Castro, Madelyn; Mulchandani, Ranya; Brolin, Kim; Makarić, Zvjezdan Lovrić; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Bonfanti, Paolo; Murri, Rita; Zvirbulis, Viesturs; Zavadska, Dace; Szuldrzynski, Konstanty; Gaio, Vânia; Popescu, Corneliu Petru; Craiu, Mihai; Hrișcă, Raluca‑Maria; Cisneros, Maria; Latorre‑Millán, Miriam; Petrović, Goranka; Lohur, Liss; McGrath, Jonathan; Ferguson, Lauren; Spolti, Anna; Donati, Katleen De Gaetano; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa, Laura; Sarajlić, Gordan; Sui, Jacklyn; Kenny, Claire; Santangelo, Rosaria; Krievins, Dainis; Barzdina, Elsa Anna; Henriques, Camila Valadas; Kosa, Alma Gabriela; Pohrib, Săftica‑Mariana; Miron, Victor Daniel; Muñoz‑Almagro, Carmen; Milagro, Anna Maria; Bacci, Sabrina; Savulescu, Camelia; VEBIS HCW VE study groupBackground: Healthcare workers (HCWs) face high occupational exposure to SARS-CoV-2 and are a priority group for vaccination. Both natural infection and vaccination-individually or combined as hybrid immunity-confer protection against SARS-CoV-2 infection. This study aimed to evaluate the protection conferred by hybrid, infection-induced, and booster vaccine-induced immunity against laboratory-confirmed SARS-CoV-2 infections in HCWs during the circulation of three pandemic and one post-pandemic Omicron sublineages. Methods: We conducted a prospective cohort study of HCWs from 18 hospitals across nine European countries. Participants underwent RT-PCR testing at enrolment and during weekly or fortnightly follow-ups. The study period was divided based on dominant Omicron sublineage circulation: BA.1/2 (Dec 16, 2021-Jun 1, 2022), BA.4/5/BQ.1 (Jun 2-Dec 31, 2022), BA.2/XBB (Jan 1-May 2, 2023), and post-pandemic XBB.1.5/BA.2.86 (Sep 1, 2023-May 21, 2024). Participants were classified into four groups: hybrid (prior infection and recent booster vaccination 7-179 days), infection-induced (prior infection, no recent vaccination), vaccine-induced immunity (recent booster vaccination, no prior infection), and a reference group (no prior infection, no recent booster vaccination). Adjusted hazard ratios (aHRs) for infection were estimated using Cox regression, adjusting for hospital, age, sex, chronic condition, and patient-facing role. Results: A total of 3 133 HCWs were included: 2572 (82%) female, 1734 (55%) aged 40-59, and 563 (29%) with ≥ 1 chronic condition. Hybrid immunity showed significant protection during BA.1/2 (aHR = 0.37, 95%CI 0.21-0.63), BA.4/5/BQ.1 (aHR = 0.36, 95%CI 0.22-0.58), and XBB.1.5/BA.2.86 (aHR = 0.53, 95%CI 0.37-0.74) periods. Infection-induced immunity was protective across all periods, most during BA.1/2 (aHR = 0.26, 95%CI 0.12-0.53), and least during BA.2/XBB (aHR = 0.66, 95%CI 0.36-1.22). Vaccine-induced immunity alone offered limited protection during BA.1/2 (aHR = 0.72, 95%CI 0.49-1.06) and BA.4/5/BQ.1 (aHR = 0.77, 95%CI 0.50-1.19), with wide confidence intervals suggesting low statistical significance. Conclusions: Hybrid and infection-induced immunity groups were more protected against infection caused by earlier Omicron sub-lineages and more protected than vaccination alone, which had no significant protective effect. These findings highlight the need for adaptive public health strategies, including timely vaccine updates and understanding of prior SARS-CoV-2 infection to inform COVID-19 vaccination policies for HCWs in the post-pandemic era.
- Protocol to measure COVID-19 XBB.1.5 vaccine effectiveness in the immunocompromised population during the 2023 autumn vaccination campaignPublication . Nunes, Baltazar; Humphreys, James; Blake, Alexandre; Savulescu, Camelia; Kissling, Esther; Nardone, Anthony; Monge Corella, Susana; Martínez-Baz, Iván; Casado, Itziar; Echeverría, Aitziber; Trobajo-Sanmartín, Camino; Castilla, Jesús; Hansen, Christian Holm; Moustsen-Helms, Ida Rask; Fabiani, Massimo; Mateo Urdiales, Alberto; Sacco, Chiara; Meijerink, Hinta; Bråthen Kristoffersen, Anja; Soares, Patricia; Machado, Ausenda; Ljung, Rickard; Pihlström, NicklasThe European Centre for Disease Prevention and Control (ECDC) started several vaccine effectiveness (VE) studies in 2020. These were included in the Vaccine Effectiveness, Burden and Impact Studies (VEBIS) project in 2021 to monitor VE in different settings and using different methods, and to provide information on different outcomes (severe disease, moderate disease, infection, transmission, etc) (1–3). Within the VEBIS project, the protocol describes the methods to estimate the Coronavirus disease 2019 (COVID-19) XBB.1.5. monovalent-adapted VE in immunocompromised persons (ICP), against COVID-19 hospitalisations and deaths, using established health data registries across six participating European Union/European Economic Area (EU/EEA) countries. The protocol is aimed at implementing a specific question that has been identified as an area where additional scientific evidence is beneficial, in the context of the ECDC/EMA Vaccine Monitoring Platform research agenda (4), adding on the routine vaccine effectiveness monitoring performed across the six countries (5). This work is performed within the VEBIS Lot 4 framework contract. The study design is a retrospective cohort study using data from ICPs eligible for COVID-19 vaccination at the start of the 2023 autumn vaccination campaign, collected routinely in electronic health record (EHR) databases. The study starts at the beginning of the vaccination campaign for each study site and ends 12 months after that. The study has two outcomes of interest: hospitalisations and deaths due to COVID-19. Data to be collected, besides the outcomes of interest, include sociodemographic (age, sex), clinical (ICP group) and COVID-19 vaccination history (brand, number of doses and dates of prior vaccine dose administration). The protocol outlines the study design and methods for analysing the data at country level and includes a plan for the pooled analysis across countries. This protocol is primarily intended to guide the implementation of the ECDC funded studies within the VEBIS project with a focus on specific objectives. Nevertheless, ECDC encourages the conduct of VE studies using this protocol and other VEBIS-related protocols as a basis in countries that do not currently plan to participate in ECDC-funded studies. Consistent protocols will facilitate the comparability of results across studies, countries, and sites.
- Relative effectiveness of the second booster COVID-19 vaccines against laboratory confirmed SARS-CoV-2 infection in healthcare workers: VEBIS HCW VE cohort study (1 October 2022-2 May 2023)Publication . Savulescu, Camelia; Prats-Uribe, Albert; Brolin, Kim; Uusküla, Anneli; Bergin, Colm; Fleming, Catherine; Zvirbulis, Viesturs; Zavadska, Dace; Szułdrzyński, Konstanty; Gaio, Vânia; Popescu, Corneliu Petru; Craiu, Mihai; Cisneros, Maria; Latorre-Millán, Miriam; Lohur, Liis; McGrath, Jonathan; Ferguson, Lauren; Abolina, Ilze; Gravele, Dagne; Machado, Ausenda; Florescu, Simin Aysel; Lazar, Mihaela; Subirats, Pilar; Clusa Cuesta, Laura; Sui, Jacklyn; Kenny, Claire; Krievins, Dainis; Barzdina, Elza Anna; Melo, Aryse; Kosa, Alma Gabriela; Miron, Victor Daniel; Muñoz-Almagro, Carmen; Milagro, Ana María; Bacci, Sabrina; Kramarz, Piotr; Nardone, Anthony; VEBIS HCW Study GroupIntroduction: Repeated COVID-19 booster vaccination was recommended in healthcare workers (HCWs) to maintain protection. We measured the relative vaccine effectiveness (rVE) of the second booster dose of COVID-19 vaccine compared to the first booster, against laboratory-confirmed SARS-CoV-2 infection in HCWs. Methods: In a prospective cohort study among HCWs from 12 European hospitals, we collected nasopharyngeal or saliva samples at enrolment and during weekly/fortnightly follow-up between October 2022 and May 2023. We estimated rVE of the second versus first COVID-19 vaccine booster dose against SARS-CoV-2 infection, overall, by time since second booster and restricted to the bivalent vaccines only. Using Cox regression, we calculated the rVE as (1-hazard ratio)*100, adjusting for hospital, age, sex, prior SARS-CoV-2 infection and at least one underlying condition. Results: Among the 979 included HCWs eligible for a second booster vaccination, 392 (40 %) received it and 192 (20 %) presented an infection during the study period. The rVE of the second versus first booster dose was -5 % (95 %CI: -46; 25) overall, 3 % (-46; 36) in the 7-89 days after receiving the second booster dose. The rVE was 11 % (-43; 45) when restricted to the use of bivalent vaccines only. Conclusion: The bivalent COVID-19 could have reduced the risk of SARS-CoV-2 infection among HCWs by 11 %. However, we note the limitation of imprecise rVE estimates due to the proportion of monovalent vaccine used in the study, the small sample size and the study being conducted during the predominant circulation of XBB.1.5 sub-lineage. COVID-19 vaccine effectiveness studies in HCWs can provide important evidence to inform the optimal timing and the use of updated COVID-19 vaccines.