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- Bergman, Peter, et al.
(författare)
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Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial
- 2021
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Ingår i: EBioMedicine. - : Elsevier BV. - 2352-3964. ; 74
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Tidskriftsartikel (refereegranskat)abstract
- Background: Patients with immunocompromised disorders have mainly been excluded from clinical trials of vaccination against COVID-19. Thus, the aim of this prospective clinical trial was to investigate safety and efficacy of BNT162b2 mRNA vaccination in five selected groups of immunocompromised patients and healthy controls.Methods: 539 study subjects (449 patients and 90 controls) were included. The patients had either primary (n=90), or secondary immunodeficiency disorders due to human immunodeficiency virus infection (n=90), allogeneic hematopoietic stem cell transplantation/CAR T cell therapy (n=90), solid organ transplantation (SOT) (n=89), or chronic lymphocytic leukemia (CLL) (n=90). The primary endpoint was seroconversion rate two weeks after the second dose. The secondary endpoints were safety and documented SARS-CoV-2 infection.Findings: Adverse events were generally mild, but one case of fatal suspected unexpected serious adverse reaction occurred. 72.2% of the immunocompromised patients seroconverted compared to 100% of the controls (p=0.004). Lowest seroconversion rates were found in the SOT (43.4%) and CLL (63.3%) patient groups with observed negative impact of treatment with mycophenolate mofetil and ibrutinib, respectively.Interpretation: The results showed that the mRNA BNT162b2 vaccine was safe in immunocompromised patients. Rate of seroconversion was substantially lower than in healthy controls, with a wide range of rates and antibody titres among predefined patient groups and subgroups. This clinical trial highlights the need for additional vaccine doses in certain immunocompromised patient groups to improve immunity.
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- Cernvall, Martin, 1980-, et al.
(författare)
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Avoidance and hyperarousal mediates the relationship between reexperiencing and dysphoria in parents of children with cancer : a longitudinal analysis
- 2012
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Ingår i: 12th International Congress of Behavioral Medicine.
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Konferensbidrag (refereegranskat)abstract
- There is little theoretical and empirical work regarding the mechanisms underlying the development of traumatic stress among parents of children with cancer. Such work would add to the understanding of this phenomenon and could inform intervention strategies for this group. Cognitive processing theory stipulates that avoidance mediates the relationship between intrusive thoughts about trauma and psychological distress (Creamer, et al., 1992). Evidence also suggests that hyperarousal predicts emotional numbing in response to trauma (Litz, et al., 1997; Weems, et al., 2003). The purpose of this study was to investigate the mediating role of avoidance and hyperarousal in the relationship between reexperiencing and dysphoria among parents of children on cancer treatment.We used data from a longitudinal study with three assessment points: T1 = 2 weeks after the child´s diagnosis (n = 249), T2 = two months after the child´s diagnosis (n = 234), and T3 = four months after diagnosis (n = 203). The PTSD-Checklist Civilian was used as a measure of symptoms of traumatic stress interpreted with Simms et al. (2002) four-factor theory of traumatic stress. Two models were evaluated with mediation analysis using bias corrected bootstrap estimation of indirect effects and 95% confidence intervals (CI; Preacher and Hayes, 2008). The first model included two indicators of avoidance at T2 as mediators of the relationship between reexperiencing at T1 and dysphoria at T3, while controlling for initial levels of included variables and gender. In the second model hyperarousal at T2 was added as a mediator.In the first model there was a significant total indirect effect from reexperiencing to dysphoria via avoidance (0.048, CI = 0.012-0.116). However, only avoidance of activities or situations reminding of the child´s disease had a significant specific indirect effect (0.044, CI = 0.009-0.097). In the second model there was a significant total indirect effect from reexperiencing to dysphoria via avoidance and hyperarousal (0.140, CI = 0.076-0.233). However, only hyperarousal contributed with a significant specific indirect effect (0.110, CI = 0.061-0.212).The current analyses suggest that avoidance and hyperarousal both are important targets for intervention in this population.
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- Cernvall, Martin, et al.
(författare)
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Experiential avoidance and rumination in parents of children on cancer treatment : relationships with posttraumatic stress symptoms and symptoms of depression
- 2016
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Ingår i: Journal of clinical psychology in medical settings. - : Springer Science and Business Media LLC. - 1068-9583 .- 1573-3572. ; 23:1, s. 67-76
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Tidskriftsartikel (refereegranskat)abstract
- We conducted a cross-sectional survey study to investigate whether there is a relationship between experiential avoidance (EA), rumination, post-traumatic stress symptoms (PTSS), and symptoms of depression, in parents of children on cancer treatment. Data from 79 parents (55 mothers) of 79 children with a median of three months since their cancer diagnosis were included in cross-sectional analyses. EA and rumination were positively correlated with PTSS and symptoms of depression. EA and rumination did not provide incremental explained variance in PTSS over and above that explained by symptoms of depression, while controlling for symptoms of anxiety and demographic characteristics. However, EA and rumination provided incremental explained variance in symptoms of depression over and above that explained by PTSS, while controlling for symptoms of anxiety and demographic characteristics. Rumination and EA are important constructs in the understanding of PTSS and symptoms of depression in parents of children on cancer treatment. Future research should delineate the temporal relationships between these constructs.
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- Cernvall, Martin, et al.
(författare)
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Internet-based guided self-help for parents of children diagnosed with cancer : Long-term follow-up of a randomized controlled trial
- 2016
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Ingår i: EABCT 2016 Abstract Book. ; , s. 470-470
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Background: A considerable proportion of parents of children on cancer treatment experience distress such as symptoms of posttraumatic stress (PTSS), depression and anxiety. The purpose was to investigate the long-term efficacy of Internetbased guided self-help for these parents.Methods: 58 parents of children on cancer treatment (median months since diagnosis = 3) were randomized to receive 10 weeks of guided self-help via the Internet or to wait-list (intervention n = 31, wait-list n = 27). The intervention utilized principles from cognitive behavior therapy and included psychoeducation, relaxation training, coping with thoughts and feelings, problem solving, and emotional writing. Weekly support via e-mail was provided. Outcomes included PTSS (PCL-C), depression (BDI-II) and anxiety (BAI) and were assessed at pre and post intervention and at one-year follow-up.Results: 18 participants completed the intervention. 16 participants in the intervention condition and 16 participants in the wait-list condition participated in the one-year follow-up. Intention-to-treat analyses indicated significant time*group interactions for all three outcomes with reductions favoring the intervention group: PCL-C; F = 10.9, < .001, BDI-II; F = 12.0, < .001, BAI; F = 14.6, < .001. At the one-year follow-up there were large between-group effect sizes for all three outcomes (Cohens d 0.8 to 1.1).Conclusions: The high drop-out rate warrants caution in interpretation of the findings. However, Internet-based guided self-help may be an accessible alternative for some parents of children on cancer treatment and findings indicate that short-term efficacy can be maintained in the long term.
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