Swedish Ethical Review Authority Research Articles

Evaluating the Effect of Supported Systematic Work Environment Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Study.

BackgroundThe work environment is a complex phenomenon in which many factors interact. Scientific research indicates a relation between the work environment and employee health, staff turnover, patient satisfaction, and patient safety. There is a great need for knowledge on how to conduct work environment interventions and practical work environment management to maximize benefits to the employees.ObjectiveThe aim of this study is to explore how Occupational Health Service (OHS) support will affect the work environment, sick leave, staff turnover, patient satisfaction, and patient safety during and following the COVID-19 pandemic in a medical ward setting.MethodsA mixed methods evaluation of a concurrent work environment quality improvement project at the Department of Internal Medicine and Geriatrics in a local hospital in the south of Sweden will be performed.ResultsThe mixed methods evaluation of the quality improvement project received funding from Futurum–Academy for Health and Care, Jönköping County Council and Region Jönköping County, and the study protocol was approved by the Swedish Ethical Review Authority. The work environment quality improvement project will continue between May 2020 and December 2021.ConclusionsThe study might contribute to increased knowledge of how work environment interventions and practical work environment management can impact the work environment, and employee health, staff turnover, patient satisfaction, and patient safety. There is a need for knowledge in this area for OHS management to provide increased benefits to employees, employers, and society as a whole.International Registered Report Identifier (IRRID)DERR1-10.2196/34152

Implementation and evaluation of Illness Management and Recovery (IMR) in mandated forensic psychiatric care – Study protocol for a multicenter cluster randomized trial

IntroductionForensic mental health care is hampered by lack of evidence-based treatments. The Swedish forensic mental health population consists of patients suffering from severe illnesses such as schizophrenia and bipolar disorders, similar to populations in international studies. Illness Management and Recovery (IMR) is an intervention for patients with serious mental illness, based on psychoeducational, cognitive-behavioral and motivational components. The purpose is to strengthen participants’ illness management skills and recovery. ObjectiveTo test effectiveness of IMR within forensic mental health by comparing it to treatment as usual. MethodThis is a cluster-randomized controlled trial. Patients in forensic mental health inpatient units are randomized to an active (IMR) or a control condition (treatment as usual). Clustering of patients is based on ward-units where inpatients are admitted. Patients in the active condition receive two group and one individual IMR sessions per week. The treatment phase is estimated to last nine months. Outcomes include illness related disability, illness management skills, sense of recovery, hope, mental health and security related problems. Outcomes are measured at baseline, four months into treatment, at treatment completion and at three months follow-up. Staff experiences of implementing IMR will be explored by a self-report measure and semi-structured interview based on Normalization Process Theory. Ethics and disseminationThe study is approved by the Swedish Ethical Review Authority (Registration No. 2020–02046). Participation will be voluntary based on written informed consent. Results will be disseminated through peer-reviewed articles and conferences. The study is registered in the US registry of clinical trials (NCT04695132).

Safety and pharmacokinetics-pharmacodynamics of a shorter tuberculosis treatment with high-dose pyrazinamide and rifampicin: a study protocol of a phase II clinical trial (HighShort-RP)

IntroductionIncreased dosing of rifampicin and pyrazinamide seems a viable strategy to shorten treatment and prevent relapse of drug-susceptible tuberculosis (TB), but safety and efficacy remains to be confirmed. This clinical...

Using stakeholders’ experiences to redesign health services for persons living with heart failure: a case study protocol in a Swedish cardiac care setting

IntroductionClinical guidelines promote recognising persons with heart failure (referred to as PWHF) as coproducers of their own care. Coproduction of healthcare—involving PWHF, families and professionals in care processes—aims to promote...

EPOS trial: the effect of air filtration through a plasma chamber on the incidence of surgical site infection in orthopaedic surgery: a study protocol of a randomised, double-blind, placebo-controlled trial

IntroductionThere is controversy regarding the importance of air-transmitted infections for surgical site infections (SSIs) after orthopaedic surgery. Research has been hindered by both the inability in blinding the exposure, and...

SLEEP: intervention with weighted blankets for children with attention deficit hyperactivity disorder (ADHD) and sleep problems: study protocol for a randomised control trial

Introduction and objectivesChildren with attention deficit hyperactivity disorder (ADHD) have an increased risk of sleep problems. Weighted blankets are one possible non-pharmacological intervention for these problems in this group of...

Effectiveness of tobacco cessation interventions for different groups of tobacco users in Sweden: a study protocol for a national prospective cohort study

IntroductionTobacco is still one of the single most important risk factors among the lifestyle habits that cause morbidity and mortality in humans. Furthermore, tobacco has a heavy social gradient, as...

Mobile app for prolonged grief among bereaved parents: study protocol for a randomised controlled trial

IntroductionBereaved parents, who have lost a child, have an elevated risk to develop mental health problems, yet, few studies have evaluated the effect of psychosocial interventions developed for bereaved parents....

Person-centred care transitions for people with stroke: study protocol for a feasibility evaluation of codesigned care transition support

BackgroundCare transitions following stroke should be bridged with collaboration between hospital staff and home rehabilitation teams since well-coordinated transitions can reduce death and disability following a stroke. However, health services...

Multiple lifestyle behaviour mHealth intervention targeting Swedish college and university students: protocol for the Buddy randomised factorial trial

IntroductionThe time during which many attend college or university is an important period for developing health behaviours, with potentially major implications for future health. Therefore, it is concerning that many...

Automated artificial intelligence-based analysis of skeletal muscle volume predicts overall survival after cystectomy for urinary bladder cancer

BackgroundRadical cystectomy for urinary bladder cancer is a procedure associated with a high risk of complications, and poor overall survival (OS) due to both patient and tumour factors. Sarcopenia is one such patient factor. We have developed a fully automated artificial intelligence (AI)-based image analysis tool for segmenting skeletal muscle of the torso and calculating the muscle volume.MethodsAll patients who have undergone radical cystectomy for urinary bladder cancer 2011–2019 at Sahlgrenska University Hospital, and who had a pre-operative computed tomography of the abdomen within 90 days of surgery were included in the study. All patients CT studies were analysed with the automated AI-based image analysis tool. Clinical data for the patients were retrieved from the Swedish National Register for Urinary Bladder Cancer. Muscle volumes dichotomised by the median for each sex were analysed with Cox regression for OS and logistic regression for 90-day high-grade complications. The study was approved by the Swedish Ethical Review Authority (2020-03985).ResultsOut of 445 patients who underwent surgery, 299 (67%) had CT studies available for analysis. The automated AI-based tool failed to segment the muscle volume in seven (2%) patients. Cox regression analysis showed an independent significant association with OS (HR 1.62; 95% CI 1.07–2.44; p = 0.022). Logistic regression did not show any association with high-grade complications.ConclusionThe fully automated AI-based CT image analysis provides a low-cost and meaningful clinical measure that is an independent biomarker for OS following radical cystectomy.

Expectant Parents’ Emotions Evoked by Pregnancy: A Longitudinal Dyadic Analysis of Couples in the Swedish Pregnancy Panel

Background: Holistic antenatal care requires knowledge of individuals’ emotional response to pregnancy. Little is known about how a pregnant woman and her partner influence each other emotionally during a pregnancy. This study examines six discrete emotions that expectant couples experience during pregnancy, how these emotions change during pregnancy, and whether the partner’s emotional responses influence each other. Methods: A longitudinal dyadic study where pregnant women and their partners (1,432 couples) rated the extent to which the pregnancy evoked joy, strength, security, worry, shame, and anger at pregnancy weeks 12–19, 22–24, and 36. Latent curve models with structured residuals identify levels of and change in these emotions over time, while accounting for between- and within-couple variance. Findings: Pregnancy evoked mainly joy, strength, security and worry, and to the same extent in both groups. Levels of anger and shame were low, but higher for pregnant women than partners. There was little to no mean-level change in all six measured emotions evoked by pregnancy, and no reciprocal effects between the partners. Interpretation: Emotions in early pregnancy are felt also in late pregnancy. Furthermore, the pregnant woman and her partner have individual emotional trajectories. The results can assist healthcare professionals and researchers target interventions to expectant mothers and partners, specifically by understanding emotional response to pregnancy as a stable confound and by not approaching the couple as one emotional unit. Funding Information: This study was funded by The Swedish Research Council (2015-01546), Knut and Alice Wallenberg Foundation (KAW2017.0245), and the University of Gothenburg. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: The Swedish Ethical Review Authority approved the SPP on April 15, 2019 (Dnr: 1061-18).

A Clash of Sexual Gender Norms and Understandings: A Qualitative Study of Homosexual, Bisexual, Transgender, and Queer Adolescents’ Experiences in Junior High Schools

The objective of this study is to explore the inclusiveness of lesbian, gay, bisexual, transgender, and queer (LGBTQ) adolescents in junior high school from the perspective of LGBTQ adolescents in Sweden. Semi-structured in-depth interviews were conducted with 10 GBTQ adolescents aged 16 to 19. The study was approved by the Swedish Ethical Review Authority (Dnr: 2019-03816). A Braun and Clark inspired thematic analysis was performed through a theoretical lens inspired by Berger and Luckmann. The analysis resulted in three themes: (a) a navigator among peers as friends and bullies, (b) adults in school supported inclusion in and exclusion from the group of peers, and (c) non-heterosexuality and non-binary gender understanding as teaching projects in junior high school. In summary the LGBTQ adolescents face multiple challenges related to identity development in hetero- and cisnormative school environments, including adults and peers and their (re)actions. Inclusive and exclusive strategies exercised by the self, adults, and peers affect adolescents’ experiences of their school time. Initiatives to increase awareness and knowledge about the LGBTQ subject in school can lead to enhanced inclusion but also to an enhanced sense of not belonging. Inclusive initiatives can contribute to enhanced inclusion or its opposite, motivating further research into LGBTQ adolescents’ experiences of junior high school from a relational perspective.

Yoga as Complementary Care for Young People Placed in Juvenile Institutions-A Study Plan.

Recent studies have established yoga practice as a mainstream complementary clinical tool within correctional environments. It is shown that regular yoga practice is coupled with improved impulse control, sustained attention, attenuated antisocial and self-harm behaviors, reduced stress, and psychological distress. No academic research until now has provided evidence of mental health benefits of yoga for institutionalized young people. In Sweden, each year more than thousand adolescents receive compulsory care at juvenile institutions run by the Swedish National Board of Institutional Care. These young people are characterized by substance abuse, aggressive and antisocial behaviors, high frequency of self-harm, and the experience of abuse. Most of them manifest attention problems, depression, anxiety, and impulsivity. They have a dramatically increased risk for recidivistic criminal behavior, continuous medical, and social care and untimely death. The present study plan aims at evaluating, with previously validated psychological measures, in a quasi-experimental design, the effects of yoga practice for institutionalized adolescents. Adolescents' experiences of participating in yoga practice will also be assessed by semi-structured individual interviews. Ethical approval was given by the Swedish Ethical Review Authority. It is hypothesized that yoga practice (in combination with the standard treatment within institutional care) will reduce institutionalized adolescents' aggression, antisocial behavior, anxiety, depression, and negative affect, and increase their cognitive flexibility (in the form of increased impulse control).

Seropositivity in blood donors and pregnant women during the first year of SARS-CoV-2 transmission in Stockholm, Sweden.

BackgroundIn Sweden, social restrictions to contain SARS‐CoV‐2 have primarily relied upon voluntary adherence to a set of recommendations. Strict lockdowns have not been enforced, potentially affecting viral dissemination. To understand the levels of past SARS‐CoV‐2 infection in the Stockholm population before the start of mass vaccinations, healthy blood donors and pregnant women (n = 5,100) were sampled at random between 14 March 2020 and 28 February 2021.MethodsIn this cross‐sectional prospective study, otherwise‐healthy blood donors (n = 2,600) and pregnant women (n = 2,500) were sampled for consecutive weeks (at four intervals) throughout the study period. Sera from all participants and a cohort of historical (negative) controls (n = 595) were screened for IgG responses against stabilized trimers of the SARS‐CoV‐2 spike (S) glycoprotein and the smaller receptor‐binding domain (RBD). As a complement to standard analytical approaches, a probabilistic (cut‐off independent) Bayesian framework that assigns likelihood of past infection was used to analyse data over time.SettingHealthy participant samples were randomly selected from their respective pools through Karolinska University Hospital. The study was carried out in accordance with Swedish Ethical Review Authority: registration number 2020–01807.ParticipantsNo participants were symptomatic at sampling, and blood donors were all over the age of 18. No additional metadata were available from the participants.ResultsBlood donors and pregnant women showed a similar seroprevalence. After a steep rise at the start of the pandemic, the seroprevalence trajectory increased steadily in approach to the winter second wave of infections, approaching 15% of all individuals surveyed by 13 December 2020. By the end of February 2021, 19% of the population tested seropositive. Notably, 96% of seropositive healthy donors screened (n = 56) developed neutralizing antibody responses at titres comparable to or higher than those observed in clinical trials of SARS‐CoV‐2 spike mRNA vaccination, supporting that mild infection engenders a competent B‐cell response.ConclusionsThese data indicate that in the first year since the start of community transmission, seropositivity levels in metropolitan in Stockholm had reached approximately one in five persons, providing important baseline seroprevalence information prior to the start of vaccination.

Help-seeking behaviour and attitudes towards internet-administered psychological support among adolescent and young adults previously treated for cancer during childhood: protocol for a survey and embedded qualitative interview study in Sweden

IntroductionA subgroup of adolescent and young adult childhood cancer survivors (AYACCS) are at increased risk of psychological distress. Despite this, AYACCS experience difficulties accessing psychological support. E-mental health (e-MH) may...

The Effect of Different National Treatment Strategies on Disability Outcome in Relapsing-Remitting Multiple Sclerosis: A Propensity Score Adjusted Comparison between Denmark and Sweden

Background: Treatment strategies for relapsing-remitting multiple sclerosis (RRMS) vary markedly between Denmark and Sweden. The objective was to investigate the influence of such differences on disease modifying treatment (DMT) and disability outcome. Methods: Patients with RRMS commencing their first DMT 2013-2016 were retrospectively included from the Swedish and Danish MS registries. Time to the 24-week confirmed disability worsening (CDW, primary outcome) and 24-week confirmed disability improvement (CDI, secondary outcome) and milestone expanded disability status scale (EDSS) score 3 and 4 end-points (secondary outcomes) were analyzed using Inverse Probability of Treatment Weighting (IPTW)-based Cox regression models with robust standard errors. The IPTW model used a propensity score to weight and correct the comparison for the imbalance of confounders observed at baseline between the two countries. Findings: A total of 2700 patients from the Swedish registry and 2161 patients from the Danish MS registry commencing a first DMT between 2013 and 2016 were included in the analysis and observed for an average of 4 years. The proportion of patients initiating with a low-moderate as compared to highly effective DMT was 92.4% (teriflunomide 42%) and 7.6% in Denmark and 62.4% (teriflunomide 2.4%) and 35% in Sweden, respectively. Swedish patients were associated with a 29% reduction in the rate of post-baseline 24-week CDW relative to Danish patients (IPTW HR 0.71; 95% CI 0.57-0.90; p=0.004). The Swedish cohort was associated with a 27% and 26% reduction in the rate of reaching EDSS 3 and 4 respectively, relative to Danish patients (HR 0.73; 95% CI 0.62-0.85; p<0.001; and 0.74; 95% CI 0.59-0.93; p=0.009, reference = Denmark). Interpretation: We show for the first time that differences in treatment strategies of RRMS have an impact on disability outcomes at a national level. Escalation of treatment efficacy seemed inferior to using more efficacious DMT as initial treatment. Funding Statement: This study was supported by the Swedish Research Council, the Swedish Brain foundation, the Karolinska University Hospital & the Patient-Centered Outcomes Research Institute (PCORI), the Swedish Multiple Sclerosis Research Foundation, the Swedish Federal Government (LUA/ALF Agreement ALFGBG-722081), the Swedish Association of Persons with Neurological Disabilities, the Research Foundation of the Multiple Sclerosis Society of Gothenburg, the Edit Jacobson Foundation, and NEURO Sweden. Declaration of Interests: TS has received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis. MM has served on scientific advisory board for Biogen, Sanofi, Roche, Novartis, Merck, Abbvie, has received honoraria for lecturing from Biogen, Merck, Novartis, Sanofi, Genzyme, has received research support and support for congress participation from Biogen, Genzyme, Roche, Merck, Novartis. FP has received research grants from Biogen and Novartis. AS reports no conflicts of interest FS has served on scientific advisory boards for, served as consultant for, received support for congress participation or received speaker honoraria from Alexion, Biogen, Merck, Novartis, Roche and Sanofi Genzyme. His laboratory has received research support from Biogen, Merck, Novartis, Roche and Sanofi Genzyme. PVR has served on scientific advisory board for Biogen, Sanofi, Roche, Novartis, Merck, and Alexion, has received honoraria for lecturing from Biogen, Merck, Novartis, Roche, has received support for congress participation from Biogen, Genzyme, Roche, Merck, Novartis. MK reports no conflicts of interest HJ has received honoraria for participating in advisory board from Biogen. JH has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker’s fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck- Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. His MS research is funded by the Swedish Research Council and the Swedish Brain foundation JL has received travel support and/or lecture honoraria from Biogen, Novartis, Merck, Alexion, Roche and SanofiGenzyme; has served on scientific advisory boards for Biogen, Novartis, Merck, Roche, BSM and SanofiGenzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, and Novartis. Ethics Approval Statement: The study was approved by the The Swedish Ethical Review Authority (Dnr: 2019-00839/1199-18), and The Danish Data Protection Authority (Org. number 202100 2973).

Sustainable Behavior Change for Health Supported by Person-Tailored, Adaptive, Risk-Aware Digital Coaching in a Social Context: Study Protocol for the STAR-C Research Programme

Introduction: The Västerbotten Intervention Programme (VIP) in the Region Västerbotten Sweden is one of the very few cardiovascular disease (CVD) prevention programmes globally that is integrated into routine primary health care. The VIP has been shown as a cost-effective intervention to significantly reduce CVD mortality. However, little is known about the effectiveness of a digital solution to tailor risk communication strategies for supporting behavioral change. STAR-C aims to develop and evaluate a technical platform for personalized digital coaching that will support behavioral change aimed at preventing CVD.Methods: STAR-C employs a mixed-methods design in seven multidisciplinary projects, which runs in two phases during 2019–2024: (i) a formative intervention design and development phase, and (ii) an intervention implementation and evaluation phase. In the 1st phase, STAR-C will model the trajectories of health behaviors and their impact on CVDs (Project 1), evaluate the role of the social environment and social networks on behavioral change (Project 2) and assess whether and how social media facilitates the spread of health information beyond targeted individuals and stimulates public engagement in health promotion (Project 3). The findings will be utilized in carrying out the iterative, user-centered design, and development of a person-tailored digital coaching platform (Project 4). In the 2nd phase, STAR-C will evaluate the implementation of the coaching programme and its effectiveness for promoting behavioral change and the spreading of health information across social networks and via social media (Project 5). The cost-effectiveness (Project 6) and ethical issues (Project 7) related to the coaching programme intervention will be evaluated.Discussion: The STAR-C research programme will address the knowledge and practice research gaps in the use of information technologies in health promotion and non-communicable disease (NCD) prevention programmes in order to narrow the health inequality gaps.Ethics: STAR-C has received approval from the Swedish Ethical Review Authority (Dnr. 2019-02924;2020-02985).Dissemination: The collaboration between Umeå University and Region Västerbotten will ensure the feasibility of STAR-C in the service delivery context. Results will be communicated with decision-makers at different levels of society, stakeholders from other regions and healthcare professional organizations, and through NGOs, local and social media platforms.

Severe COVID-19 in People with Type 1 and Type 2 Diabetes in Sweden: A Nationwide Retrospective Case-Control Study

Introduction: Whether infection with SARS-CoV-2 leads to excess risk of requiring hospitalization or intensive care in persons with diabetes has not been reported, nor have risk factors in diabetes associated with increased risk for these outcomes.Methods: We included 44,639 and 411,976 adult patients with type 1 and type 2 diabetes alive on Jan 1, 2020, and compared them to controls matched for age, sex, and county of residence (n=204,919 and 1,948,900). Standardized rates of hospitalizations, admissions to intensive care and death were estimated and hazard ratios were calculated using Cox regression analyses.Findings: There were 10,486 hospitalizations and 1,416 admissions into intensive care. A total of 1,175 patients with diabetes and 1,820 matched controls died from COVID-19, of these 53·2% had been hospitalized and 10·7% had been in intensive care. Patients with type 2 diabetes, compared to controls, displayed a hazard ratio (HR) of 2·22, 95%CI 2·13-2·32) of being hospitalized, which decreased to HR 1·40, 95%CI 1·34-1·47) after adjustment for sociodemographic factors, pharmacological treatment and comorbidities, had higher risk for admission to intensive care (HR 2·49, 95%CI 2·22-2·79, decreasing to 1·42, 95%CI 1·25-1·62 after adjustment, and increased risk for death (HR 2·19, 95%CI 2·03-2·36, adjusted 1·50, 95%CI 1·39-1·63). HR for hospitalization for type 1 diabetes was 2·10, 95%CI 1·72-2·57), decreasing to 1·25, 95%CI 0·3097-1·62) after adjustment· Patients with diabetes type 1 were twice as likely to require intensive care for COVID-19, however, not after adjustment (HR 1·49, 95%CI 0·75-2·92), and more likely to die (HR 2·90, 95% CI 1·6554-5·47), but not independently of other factors (HR 1·38, 95% CI 0·64-2·99). Among people with diabetes, elevated glycated hemoglobin levels were associated with higher risk for most outcomes.Interpretation: In this nationwide study, type 2 diabetes was independently associated with increased risk of hospitalization, admission to intensive care and death for COVID-19, whereas type 1 diabetes was not independently associated with excess risk for any outcome.Funding Statement: This work was supported by grants from: the Swedish state under an agreement concerning research and education of doctors [ALFGBG-717211]; the Swedish Heart and Lung Foundation [2018- 0366]; the Swedish Research Council [2013-05187, VRREG 2019-00193, 2020-05792]Declaration of Interests: Professor Eliasson reports personal fees (expert panels, lectures) from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Mundipharma, Navamedic, NovoNordisk, RLS Global, grants and personal fees from Sanofi, all outside the submitted work. NN declare that they have no conflict of interest. MG reports personal fees (scientific advisory boards, lectures) from Gilead Sciences, GSK/ViiV, MSD, Biogen, Amgen, Novocure, Novo Nordic and research grants from Gilead Sciences, all outside the submitted work. All other authors have nothing to disclose. Ethics Approval Statement: The Swedish Ethical Review Authority approved the study.

Appearance of IgG to SARS-CoV-2 in Saliva Effectively Indicates Seroconversion in mRNA Vaccinated Immunocompromised Individuals

Background: mmunocompromised individuals are highly susceptible to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Whether vaccine-induced immunity in these individuals involves the oral cavity, a primary site of infection, is presently unknown.Methods: Immunocompromised individuals (n=404) and healthy controls (n=82) participated in a prospective clinical trial encompassing two doses of the mRNA BNT162b2 vaccine. Immunocompromised individuals included primary immunodeficiencies (PID) and secondary immunodeficiencies caused by human immunodeficiency virus (HIV) infection, allogeneic hematopoietic stem cell transplantation (HSCT)/chimeric antigen receptor T cell therapy (CAR-T), solid organ transplantation (SOT), and chronic lymphocytic leukemia (CLL). Saliva and serum samples were collected at four time points from the first vaccine dose until 2 weeks after second dose. SARS-CoV-2 spike specific immunoglobulin G (IgG) responses were quantified by a multiplex bead-based assay in saliva and correlated to paired serum IgG titers determined by Elecsys Anti-SARS-CoV-2 S assay.Results: IgG responses to the SARS-CoV-2 spike full-length tr­imeric glycoprotein (Spike-f) and S1 subunit in saliva in the HIV and HSCT/CAR-T groups were comparable to healthy controls. In contrast, PID, SOT, and CLL patients all displayed weaker responses which were mainly influenced by disease parameters or immunosuppressants. Salivary IgG levels strongly correlated with serum IgG titers on days 21 and 35 (rho=0.8079 and 0.7768, p=Conclusions: Saliva conveys humoral responses induced by BNT162b2 vaccination. The predictive power makes it highly suitable for screening low responding/vulnerable groups for revaccination.Funding: Knut and Alice Wallenberg Foundation, Erling Perssons family foundation, Region Stockholm, Swedish Research Council, Karolinska Institutet, The Swedish Blood Cancer Foundation and the organization for PID patient group in Sweden, and Nordstjernan AB. Center for Medical Innovation (CIMED), the Swedish Medical Research Council and the Stockholm County Council (ALF).Declaration of Interests: The authors have declared that no conflict of interest exists.Ethics Approval Statement: The study was approved by the Swedish Medical Product Agency (ID 5.1-2021-5881) and the Swedish Ethical Review Authority (ID 2021-00451 and 2020-06381). All participants provided written informed consent. Trial Registration: This trial was registered at EudraCT (no. 2021-000175-37), and clinicaltrials.gov (no. 2021-000175-37).