| 1. |
- Boutry, Céline, et al.
(author)
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The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster : Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70
- 2022
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In: Clinical Infectious Diseases. - : Oxford University Press. - 1058-4838 .- 1537-6591. ; 74:8, s. 1459-1467
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Journal article (peer-reviewed)abstract
- Efficacy against herpes zoster and immune responses to the adjuvanted recombinant zoster vaccine plateaued at high levels between 5.1 and 7.1 years (mean) post-vaccination, suggesting that its clinical benefit in older adults is sustained for at least 7 years post-vaccination. Background This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age >= 50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after >= 2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Methods Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing >= 2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Results Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Conclusions Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination.
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| 2. |
- Ferguson, Murdo, et al.
(author)
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Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults
- 2024
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In: Vaccine: X. - : Elsevier. - 2590-1362. ; 18
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Journal article (peer-reviewed)abstract
- Background: Previous phase 3 studies showed that the AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine for older adults (RSVPreF3 OA) is well tolerated and efficacious in preventing RSV-associated lower respiratory tract disease in adults ≥ 60 years of age. This study evaluated lot-to-lot immunogenicity consistency, reactogenicity, and safety of three RSVPreF3 OA lots. Methods: This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded. Results: A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: GMC ratios were 1.06 (95 % CI: 0.94–1.21), 0.92 (0.81–1.04), and 0.87 (0.77–0.99) between the lot pairs (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these–a case of atrial fibrillation–was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related. Conclusion: This study demonstrated lot-to-lot immunogenicity consistency of three RSVPreF3 OA vaccine lots and indicated that the vaccine had an acceptable safety profile. ClinicalTrials.gov: NCT05059301. © 2024 GSK
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| 3. |
- Lindberg, Terese, et al.
(author)
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Prevalence and Incidence of Atrial Fibrillation and Other Arrhythmias in the General Older Population : Findings From the Swedish National Study on Aging and Care
- 2019
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In: Gerontology and geriatric medicine. - : SAGE PUBLICATIONS INC. - 2333-7214. ; 5
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Journal article (peer-reviewed)abstract
- Aim: To study the prevalence and cumulative incidence of arrhythmias in the general population of adults aged 60 and older over a 6-year period. Study Design and Setting: Data were taken from the Swedish National Study on Aging and Care (SNAC), a national, longitudinal, multidisciplinary study of the general elderly population (defined as 60 years of age or older). A 12-lead resting electrocardiography (ECG) was performed at baseline and 6-year follow-up. Results: The baseline prevalence of atrial fibrillation (AF) was 4.9% (95% confidence interval [CI] = [4.5%, 5.5%]), and other arrhythmias including ventricular premature complexes (VPCs), supraventricular tachycardia (SVT), and supraventricular extrasystole (SVES) were seen in 8.4% (7.7%, 9.0%) of the population. A first- or second-degree atrioventricular (AV) block was found in 7.1% of the population (95% CI = [6.5%, 7.7%]), and there were no significant differences between men and women in baseline arrhythmia prevalence. The 6-year cumulative incidence of AF was 4.1% (95% CI = [3.5%, 4.9%]), or 6.9/1,000 person-years (py; 95% CI = [5.7, 8.0]). The incidence of AF, other arrhythmias, AV block, and pacemaker-induced rhythm was significantly higher in men in all cohorts except for the oldest. Conclusion: Our data highlight the prevalence and incidence of arrhythmias, which rapidly increase with advancing age in the general population.
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| 4. |
- López-Fauqued, M., et al.
(author)
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Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
- 2019
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In: Vaccine. - : Elsevier Ltd. - 0264-410X .- 1873-2518. ; 37:18, s. 2482-2493
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Journal article (peer-reviewed)abstract
- Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA
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| 5. |
- Nordberg, Marika, et al.
(author)
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Aetiology of tick-borne infections in an adult swedish population-are co-infections with multiple agents common
- 2014
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In: Open Journal of Clinical Diagnostics. - Scientific Research : Scientific Research Publishing, Inc.. - 2162-5816 .- 2162-5824. ; 4:1, s. 31-40
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Journal article (peer-reviewed)abstract
- In Scandinavia, tick-borne infections affecting humans include Lyme borreliosis (LB), tick-borne encephalitis (TBE) and human granulocytic anaplasmosis (HGA). Each of these infections can present with unspecific symptoms. In this prospective clinical study, we recruited patients based on two independent inclusion criteria; 1) patients with unspecific symptoms, i.e. fever (≥38.0˚C) or a history of feverishness and/or any combination of headache, myalgia or arthralgia and 2) patients with erythema migrans (EM), following an observed tick bite or tick exposure within one month prior to onset of symptoms. A total of 206 patients fulfilled the study. Among these, we could identify 186 cases of LB (174 with EM), 18 confirmed and two probable cases of HGA and two cases of TBE. Thirteen of the HGA cases presented without fever. Furthermore, 22 of the EM patients had a sub-clinical co-infection with Anaplasma phagocytophilum, based on serology. Both TBE cases had co-infections, one with Borrelia burgdorferi and one with Anaplasma phagocytophilum. We conclude that it is important to consider several causative agents and possible co-infections in the clinical management of infectious diseases where ticks may be suspected as vectors.
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| 6. |
- Rennemark, Mikael, 1951-, et al.
(author)
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Relationships between frequency of moderate physical activity and longevity : an 11-year follow-up study
- 2018
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In: Gerontology and geriatric medicine. - : Sage Publications. - 2333-7214. ; 4, s. 1-8
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Journal article (peer-reviewed)abstract
- Objectives: Moderate physical activity gains survival. There are, however, several variables that may affect this relationship. In this study, the relationship between moderate physical activity and longevity was investigated, taking into account age, gender, smoking habits, cohabitation status, body mass index, leg strength and balance, education level and cognitive function. Method: A sample of 8,456 individuals aged 60 to 96 years, representative of the Swedish population, was included. Participants were followed from 2004 to 2015. Cox regression analyses were used to investigate the predictive value of physical activity on longevity. Results: Participants still alive in the follow-up measure were more physically active on a moderate level. Being active 2 to 3 times a week or more was related to a 28% lower risk of not being alive at the follow-up measure. Discussion: The low frequency of physical activity, necessary for survival benefits should be considered in public health programs.
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| 7. |
- Svärd, Anna, et al.
(author)
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Antibodies against Porphyromonas gingivalis in serum and saliva and their association with rheumatoid arthritis and periodontitis. : Data from two rheumatoid arthritis cohorts in Sweden
- 2023
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In: Frontiers in Immunology. - : Frontiers Media SA. - 1664-3224. ; 14
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Journal article (peer-reviewed)abstract
- Background: Periodontitis and oral pathogenic bacteria can contribute to the development of rheumatoid arthritis (RA). A connection between serum antibodies to Porphyromonas gingivalis (P. gingivalis) and RA has been established, but data on saliva antibodies to P. gingivalis in RA are lacking. We evaluated antibodies to P. gingivalis in serum and saliva in two Swedish RA studies as well as their association with RA, periodontitis, antibodies to citrullinated proteins (ACPA), and RA disease activity.Methods: The SARA (secretory antibodies in RA) study includes 196 patients with RA and 101 healthy controls. The Karlskrona RA study includes 132 patients with RA >= 61 years of age, who underwent dental examination. Serum Immunoglobulin G (IgG) and Immunoglobulin A (IgA) antibodies and saliva IgA antibodies to the P. gingivalis-specific Arg-specific gingipain B (RgpB) were measured in patients with RA and controls.Results: The level of saliva IgA anti-RgpB antibodies was significantly higher among patients with RA than among healthy controls in multivariate analysis adjusted for age, gender, smoking, and IgG ACPA (p = 0.022). Saliva IgA anti-RgpB antibodies were associated with RA disease activity in multivariate analysis (p = 0.036). Anti-RgpB antibodies were not associated with periodontitis or serum IgG ACPA.Conclusion: Patients with RA had higher levels of saliva IgA anti-RgpB antibodies than healthy controls. Saliva IgA anti-RgpB antibodies may be associated with RA disease activity but were not associated with periodontitis or serum IgG ACPA. Our results indicate a local production of IgA anti-RgpB in the salivary glands that is not accompanied by systemic antibody production.
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| 8. |
- Svärd, Anna, et al.
(author)
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Antibodies to citrullinated peptides in serum and saliva in patients with rheumatoid arthritis and their association to periodontitis
- 2020
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In: Clinical and Experimental Rheumatology. - : CLINICAL & EXPER RHEUMATOLOGY. - 0392-856X .- 1593-098X. ; 38:4, s. 699-704
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Journal article (peer-reviewed)abstract
- Objectives A connection between prevalence of rheumatoid arthritis (RA) and periodontitis has been reported. The hypothesis for this association involves increased citrullination in the oral mucosa in patients with periodontitis. Whether ongoing periodontitis has an effect on IgA antibodies to citrullinated peptides (ACPA) in saliva is unknown. We studied IgA ACPA in saliva and serum and their relation to periodontitis and smoking in a population-based elderly RA cohort. Methods A population-based cohort of patients with RA >= 61 years of age (n=132) was examined by rheumatologists and a dental hygienist. Analyses of IgG ACPA in serum and IgA ACPA in serum and saliva were performed. The presence of ACPA was compared in patients with RA with and without periodontitis. Results IgA ACPA in serum occurred in 35% of RA patients with periodontitis and in 43% of RA patients without periodontitis (p=0.740). IgG ACPA in serum was found in 66% of RA patients with periodontitis, and in 69% without periodontitis (p=0.740). IgA ACPA in saliva occurred in 20% with periodontitis and 55% without periodontitis (p=0.062). A logistic regression analysis adjusting for age, gender and smoking gave an odds ratio (OR) of 0.456 (95% CI=0.183-1.137, p=0.092) for saliva IgA ACPA positive individuals to have periodontitis. Conclusions IgA ACPA in serum or saliva was not more common in RA patients with periodontitis. This implies that local production of ACPA by the oral mucosa is not enhanced by periodontal inflammation, in patients with established RA.
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| 9. |
- Wimo, Anders, et al.
(author)
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Formal and informal care of community-living older people : A population-based study from the swedish national study on aging and care
- 2017
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In: The Journal of Nutrition, Health & Aging. - : SPRINGER FRANCE. - 1279-7707 .- 1760-4788. ; 21:1, s. 17-24
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Journal article (peer-reviewed)abstract
- Objectives: Study formal and informal care of community-living older people in the Swedish National study of Aging and Care (SNAC). Design: Cross-sectional, population based cohort. Setting: Three areas in Sweden: Municipality of Nordanstig, Stockholm and Skane County. Participants: 3,338 persons >= 72 years. Measurements: Patterns and amounts of informal and formal care by cognition and area of residence. Results: 73% received no care; 14% formal care; and 17% informal care (7% received both). In the whole study population, including those who used no care, individuals in small municipalities received 9.6 hours of informal care/month; in mid-size municipalities, 6.6; and in urban areas, 5.6. Users of informal care received 33.1 hours of informal care/month in small municipalities, 54.6 in mid-size municipalities and 36.1 in urban areas. Individuals with cognitive impairment received 14.1 hours of informal care/month, 2.7 times more than people with no/slight impairment. In the whole study population, individuals in small municipalities received an average of 3.2 hours of formal care/month; in mid-size municipalities 1.4; and in urban areas, 2.6. Corresponding figures for formal care users were 29.4 hours in small municipalities, 13.6 in mid-size municipalities and 16.7 in urban areas. Formal care users received 7.1 hours, and informal care users, 5.9 hours for each hour/month received by people in the study population as a whole. Conclusions: More informal than formal care was provided. Informal care is more frequent in small municipalities than urban areas and for those with than without cognitive impairment. The relationship between data on the whole population and the data on users or care indicates that population-based data are needed to avoid overestimates of care.
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