Immunogenicity of a third dose with mRNA-vaccines in the ChAdOx1-S/BNT162b2 vaccination regimen against SARS-CoV-2 variants.

CombiVacS study has demonstrated a strong immune response of the heterologous ChAdOx1-S/BNT162b2 vaccine combination. The primary outcomes of the study were to assess the humoral immune response against SARS-CoV-2, 28 days after a third dose of a mRNA vaccine, in subjects that received a previous prime-boost scheme with ChAdOx1-S/BNT162b2. Secondary outcomes extended the study to 3 and 6 months. The third vaccine dose of mRNA-1273 in naive participants previously vaccinated with ChAdOx1-S/BNT162b2 regimen reached higher neutralizing antibodies titers against the variants of concern Delta and BA.1 lineage of Omicron compared with those receiving a third dose of BNT162b2 at day 28. These differences between BNT162b2 and mRNA-1273 arms were observed against the ancestral variant G614 at day 90. Suboptimal neutralizing response was observed against BQ.1.1, XBB.1.5/XBB.1.9, and JN.1 in a relevant proportion of individuals 180 days after the third dose, even after asymptomatic Omicron breakthrough infections. EudraCT (2021-001978-37); ClinicalTrials.gov (NCT04860739).

Inequalities in health outcomes of SARS-CoV-2 infection by migration status in Barcelona, Spain.

Background: Migrants are a vulnerable population at risk of worse health outcomes due to legal status, language barriers, and socioeconomic and cultural factors. Considering the conflicting literature on the subject, it is important to further explore the extent and nature of these inequalities. Objective: The aim of this study is to compare health outcomes associated with SARS-CoV-2 infection between Spanish native and migrant population living in Barcelona. Methods: Observational retrospective cohort study including all adult cases of SARS-CoV-2 infection who visited a tertiary hospital in Barcelona between the 1st March 2020 and the 31st March 2022. We established the following five health outcomes: the presence of symptomatology, hospitalisation, intensive care unit admission, use of mechanical ventilation, and in-hospital 30-day mortality (IHM). Using Spanish natives as a reference, Odds Ratios (OR) with 95% confidence interval (95%CI) were calculated for migrants by multivariate logistic regression and adjusted by sociodemographic and clinical factors. Results: Of 11,589 patients (46.8% females), 3,914 were born outside of Spain, although 34.8% of them had legal citizenship. Most migrants were born in the Americas Region (20.3%), followed by other countries in Europe (17.2%). Migrants were younger than natives (median 43 [IQR 33-55] years vs. 65 [49-78] years) and had a higher socioeconomic privation index, less comorbidities, and fewer vaccine doses. Adjusted models showed migrants were more likely to report SARS-CoV-2 symptomatology with an adjusted OR of 1.36 (95%CI 1.20-1.54), and more likely to be hospitalised (OR 1.11 [IC95% 1.00-1.23], p < 0.05), but less likely to experience IHM (OR 0.67 [IC95% 0.47-0.93], p < 0.05). Conclusion: Characteristics of migrant and native population differ greatly, which could be translated into different needs and health priorities. Native population had higher odds of IHM, but migrants were more likely to present to care symptomatic and to be hospitalised. This could suggest disparities in healthcare access for migrant population. More research on health disparities beyond SARS-CoV-2 in migrant populations is necessary to identify gaps in healthcare access and health literacy.

Immunogenic dynamics and SARS-CoV-2 variant neutralisation of the heterologous ChAdOx1-S/BNT162b2 vaccination: Secondary analysis of the randomised CombiVacS study.

Background: The CombiVacS study was designed to assess immunogenicity and reactogenicity of the heterologous ChAdOx1-S/BNT162b2 combination, and 14-day results showed a strong immune response. The present secondary analysis addresses the evolution of humoral and cellular response up to day 180. Methods: Between April 24 and 30, 2021, 676 adults primed with ChAdOx1-S were enrolled in five hospitals in Spain, and randomised to receive BNT162b2 as second dose (interventional group [IG]) or no vaccine (control group [CG]). Individuals from CG received BNT162b2 as second dose and also on day 28, as planned based on favourable results on day 14. Humoral immunogenicity, measured by immunoassay for SARS-CoV-2 receptor binding domain (RBD), antibody functionality using pseudovirus neutralisation assays for the reference (G614), Alpha, Beta, Delta, and Omicron variants, as well as cellular immune response using interferon-γ and IL-2 immunoassays were assessed at day 28 after BNT162b2 in both groups, at day 90 (planned only in the interventional group) and at day 180 (laboratory data cut-off on Nov 19, 2021). This study was registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739). Findings: In this secondary analysis, 664 individuals (441 from IG and 223 from CG) were included. At day 28 post vaccine, geometric mean titres (GMT) of RBD antibodies were 5616·91 BAU/mL (95% CI 5296·49-5956·71) in the IG and 7298·22 BAU/mL (6739·41-7903·37) in the CG (p < 0·0001). RBD antibodies titres decreased at day 180 (1142·0 BAU/mL [1048·69-1243·62] and 1836·4 BAU/mL [1621·62-2079·62] in the IG and CG, respectively; p < 0·0001). Neutralising antibodies also waned from day 28 to day 180 in both the IG (1429·01 [1220·37-1673·33] and 198·72 [161·54-244·47], respectively) and the CG (1503·28 [1210·71-1866·54] and 295·57 [209·84-416·33], respectively). The lowest variant-specific response was observed against Omicron-and Beta variants, with low proportion of individuals exhibiting specific neutralising antibody titres (NT50) >1:100 at day 180 (19% and 22%, respectively). Interpretation: Titres of RBD antibodies decay over time, similar to homologous regimes. Our findings suggested that delaying administration of the second dose did not have a detrimental effect after vaccination and may have improved the response obtained. Lower neutralisation was observed against Omicron and Beta variants at day 180. Funding: Funded by Instituto de Salud Carlos III (ISCIII).

How do we measure gender discrimination? Proposing a construct of gender discrimination through a systematic scoping review.

BACKGROUND: Gender discrimination (GD) has been frequently linked to mental health. The heterogeneity of how GD is defined has led to variation around the analysis of GD. This might affect the study of the association between GD and health outcomes. The main goal of this systematic scoping review is to operationalize the definition of the GD construct. METHODS: Three search strategies were set in Pubmed, CINAHL and PsycINFO. The first strategy obtained results mainly about women, while the second focused on men. The third strategy focused on the identification of GD questionnaires. The prevalence of GD, factors and consequences associated with GD perception, and forms of discrimination were the principal variables collected. Risk of bias was assessed (PROSPERO:CRD42019120719). RESULTS: Of the 925 studies obtained, 84 were finally included. 60 GD questionnaires were identified. GD prevalence varied between 3.4 and 67 %. Female gender and a younger age were the factors most frequently related to GD. Poorer mental health was the most frequent consequence. Two components of the GD construct were identified: undervaluation (different recognition, opportunities in access, evaluation standards and expectations) and different treatment (verbal abuse and behaviour). CONCLUSIONS: Two-component GD definition can add order and precision to the measurement, increase response rates and reported GD.

Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial.

BACKGROUND: To date, no immunological data on COVID-19 heterologous vaccination schedules in humans have been reported. We assessed the immunogenicity and reactogenicity of BNT162b2 (Comirnaty, BioNTech, Mainz, Germany) administered as second dose in participants primed with ChAdOx1-S (Vaxzevria, AstraZeneca, Oxford, UK). METHODS: We did a phase 2, open-label, randomised, controlled trial on adults aged 18-60 years, vaccinated with a single dose of ChAdOx1-S 8-12 weeks before screening, and no history of SARS-CoV-2 infection. Participants were randomly assigned (2:1) to receive either BNT162b2 (0·3 mL) via a single intramuscular injection (intervention group) or continue observation (control group). The primary outcome was 14-day immunogenicity, measured by immunoassays for SARS-CoV-2 trimeric spike protein and receptor binding domain (RBD). Antibody functionality was assessed using a pseudovirus neutralisation assay, and cellular immune response using an interferon-γ immunoassay. The safety outcome was 7-day reactogenicity, measured as solicited local and systemic adverse events. The primary analysis included all participants who received at least one dose of BNT162b2 and who had at least one efficacy evaluation after baseline. The safety analysis included all participants who received BNT162b2. This study is registered with EudraCT (2021-001978-37) and ClinicalTrials.gov (NCT04860739), and is ongoing. FINDINGS: Between April 24 and 30, 2021, 676 individuals were enrolled and randomly assigned to either the intervention group (n=450) or control group (n=226) at five university hospitals in Spain (mean age 44 years [SD 9]; 382 [57%] women and 294 [43%] men). 663 (98%) participants (n=441 intervention, n=222 control) completed the study up to day 14. In the intervention group, geometric mean titres of RBD antibodies increased from 71·46 BAU/mL (95% CI 59·84-85·33) at baseline to 7756·68 BAU/mL (7371·53-8161·96) at day 14 (p<0·0001). IgG against trimeric spike protein increased from 98·40 BAU/mL (95% CI 85·69-112·99) to 3684·87 BAU/mL (3429·87-3958·83). The interventional:control ratio was 77·69 (95% CI 59·57-101·32) for RBD protein and 36·41 (29·31-45·23) for trimeric spike protein IgG. Reactions were mild (n=1210 [68%]) or moderate (n=530 [30%]), with injection site pain (n=395 [88%]), induration (n=159 [35%]), headache (n=199 [44%]), and myalgia (n=194 [43%]) the most commonly reported adverse events. No serious adverse events were reported. INTERPRETATION: BNT162b2 given as a second dose in individuals prime vaccinated with ChAdOx1-S induced a robust immune response, with an acceptable and manageable reactogenicity profile. FUNDING: Instituto de Salud Carlos III. TRANSLATIONS: For the French and Spanish translations of the abstract see Supplementary Materials section.

Electroconvulsive therapy protocol adaptation during the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, electroconvulsive therapy units have had to confront challenges such as the infectious hazard due to aerosol-generating ventilation, or the lack of staff and material resources. Our objective was to elaborate a protocol to make ECT during the COVID-19 pandemic a safer procedure for patients and professionals. METHODS: A multidisciplinary workgroup (including mental health, anesthesia, preventive medicine, and occupational risk professionals) was formed in the Hospital Clínic de Barcelona, in March 2020. A core group conducted a review of the scientific literature and healthcare organizations' guidelines and wrote a protocol draft. Then, a discussion with the workgroup was made until consensus was reached. The protocol has been continuously updated. Discussions were made by group e-mailing and video conferencing. RESULTS: The protocol includes the following main areas: (1) ECT unit's structural and functional considerations; (2) SARS-CoV-2 screening protocol; (3) ECT clinical practice adaptation (personal protective equipment, airway management, recovery room, and maintenance of the facilities); (4) management of COVID-19 cases; and (5) protocol assessment. LIMITATIONS: The literature review was not systematic; the consensus was not based on a structured methodology. For other ECT units, local advisories may not be valid, and resource shortages (such as anesthetist availability, or the lack of respirators and PCR tests) may impede or prevent their implementation. CONCLUSIONS: During the COVID-19 pandemic, ECT should continue to be advocated as an essential medical procedure. It is recommended that each ECT unit develop its own protocol. This proposal may be used as a reference.

[Translation and cross-cultural adaptation of the Quick Environmental Exposure and Sensitivity Inventory for use in the Spanish population]. / Traducción y adaptación transcultural del cuestionario Quick Environmental Exposure and Sensitivity Inventory a la población española.

OBJECTIVE: To perform the translation and cross-cultural adaptation of the Quick Environmental Exposure and Sensitivity Inventory (QEESI) for the Spanish population. PATIENTS AND METHODS: Seventy-seven patients diagnosed with multiple chemical sensitivity (MCS) and 154 subjects without the syndrome, matched by sex and age, were included in this cross-sectional study. A translation, back-translation and a cross-cultural adaptation of the original questionnaire were performed. Subsequently, the Mann-Whitney test was used to compare the median score by scale between the subjects previously diagnosed and undiagnosed. Internal consistency by scale was analyzed (Cronbach's α). RESULTS: Significant higher median score was found in subjects previously diagnosed on 4 out of 5 scales (P<.001). Good internal consistency was found in these 4 scales. Previously diagnosed subjects presented lower median scores on the Masking Index scale (P<.001). CONCLUSIONS: Except for the Masking Index, the scales present strong potential for detecting cases of MCS among symptomatic subjects.