scholarly journals GRAd-COV2, a gorilla adenovirus based candidate vaccine against COVID-19, is safe and immunogenic in young and older adults

2021 ◽  
Author(s):  
Simone Lanini ◽  
Stefania Capone ◽  
Andrea Antinori ◽  
Stefano Milleri ◽  
Emanuele Nicastri ◽  
...  
Keyword(s):  
Older Adults ◽  
Neutralizing Antibodies ◽  
Phase 1 ◽  
Age Groups ◽  
T Cell Response ◽  
Open Label ◽  
Younger Age ◽  
Open Label Trial ◽  
Older Subjects ◽  
Further Development

Safe and effective vaccines against coronavirus disease 2019 (COVID-19) are urgently needed to control the ongoing pandemic. Although impressive progress has been made with several COVID-19 vaccines already approved, it is clear that those developed so far cannot meet the global vaccine demand. We have developed a COVID-19 vaccine based on a replication-defective gorilla adenovirus expressing the stabilized pre-fusion SARS-CoV-2 Spike protein, named GRAd-COV2. We aimed to assess the safety and immunogenicity of a single-dose regimen of this vaccine in healthy younger and older adults to select the appropriate dose for each age group. To this purpose, a phase 1, dose-escalation, open-label trial was conducted including 90 healthy subjects, (45 aged 18-55 years and 45 aged 65-85 years), who received a single intramuscular administration of GRAd-CoV2 at three escalating doses. Local and systemic adverse reactions were mostly mild or moderate and of short duration, and no serious AE was reported. Four weeks after vaccination, seroconversion to Spike/RBD was achieved in 43/44 young volunteers and in 45/45 older subjects. Consistently, neutralizing antibodies were detected in 42/44 younger age and 45/45 older age volunteers. In addition, GRAd-COV2 induced a robust and Th1-skewed T cell response against the S antigen in 89/90 subjects from both age groups. Overall, the safety and immunogenicity data from the phase 1 trial support further development of this vaccine.

scholarly journals Age-Cohort Differences in Longitudinal Associations Between the Rate of Internet Use and Memory Functioning

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 410-410
Author(s):  
Vineet Raichur ◽  
Lindsay Ryan ◽  
Richard Gonzalez ◽  
Jacqui Smith
Keyword(s):  
Older Adults ◽  
Episodic Memory ◽  
Cognitive Complexity ◽  
Internet Use ◽  
Age Groups ◽  
Word Recall ◽  
Use Patterns ◽  
Younger Age ◽  
Rate Of Increase ◽  
Over Time

Abstract Cross-sectional analyses of internet use patterns among older adults find that the rate of internet use is less with greater physical and memory difficulties. It is not clear, however, how age-cohorts differ in their internet use as physical and memory difficulties increase over time. In addition to factors such as increasing accessibility (cost) and social influences, the expansion and cognitive complexity of functions performed by the internet-enabled devices over time could influence internet use patterns. In this study, we investigate how the association between internet use and episodic memory difficulties over time varies between cohorts. We analyzed longitudinal data from the Health and Retirement Study (N = 15,703 in 2002; Aged 51 and older) between years 2002-2016 using mixed effects logistic regression models. Immediate and delayed word recall measures were used to assess episodic memory. Rate of internet use in the sample increased from 30% in 2002 to 53% in 2016. Rate of internet use among younger age groups was significantly higher in the baseline year. Younger age groups also showed a significantly higher rate of increase in internet use over time. In general, internet use decreased with episodic memory impairment. In addition to these effects, the effect of episodic memory on the rate of increase in internet use over time is lower in younger cohorts. These results indicate that younger cohorts of older adults are more likely to maintain internet use as they continue to age and therefore could better utilize technology for communication, social interactions and health interventions.

scholarly journals Housing Transitions and Recovery of Older Adults Following Hurricane Sandy

2018 ◽  
Vol 74 (6) ◽  
pp. 1041-1052 ◽  
Author(s):  
Alexis A Merdjanoff ◽  
Rachael Piltch-Loeb ◽  
Sarah Friedman ◽  
David M Abramson
Keyword(s):  
Older Adults ◽  
Age Groups ◽  
Family Health ◽  
Hurricane Sandy ◽  
Younger Adults ◽  
Younger Age ◽  
Observational Cohort ◽  
Emergency Housing ◽  
Young Old ◽  
Post Disaster

Abstract Objectives This study explores the effects of social and environmental disruption on emergency housing transitions among older adults following Hurricane Sandy. It is based upon the Sandy Child and Family Health (S-CAFH) Study, an observational cohort of 1,000 randomly sampled New Jersey residents living in the nine counties most affected by Sandy. Methods This analysis examines the post-Sandy housing transitions and recovery of the young-old (55–64), mid-old (65–74), and old-old (75+) compared with younger adults (19–54). We consider length of displacement, number of places stayed after Sandy, the housing host (i.e., family only, friends only, or multi-host), and self-reported recovery. Results Among all age groups, the old-old (75+) reported the highest rates of housing damage and were more likely to stay in one place besides their home, as well as stay with family rather than by themselves after the storm. Despite this disruption, the old-old were most likely to have recovered from Hurricane Sandy. Discussion Findings suggest that the old-old were more resilient to Hurricane Sandy than younger age groups. Understanding the unique post-disaster housing needs of older adults can help identify critical points of intervention for their post-disaster recovery.

scholarly journals WHY DON’T OLDER ADULTS USE SENIOR CENTERS? EVIDENCE FROM A SAMPLE OF MASSACHUSETTS ADULTS AGE 50 AND OLDER

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S498-S498
Author(s):  
Ceara Somerville ◽  
Nidya Velasco Roldan ◽  
Cindy N Bui ◽  
Caitlin E Coyle
Keyword(s):  
Older Adults ◽  
Age Groups ◽  
Community Dwelling ◽  
Senior Center ◽  
Community Resource ◽  
Senior Centers ◽  
Data Set ◽  
Younger Age ◽  
And Gender ◽  
Vast Range

Abstract Senior centers are an integral community resource, providing programs and services intended to meet the vast range of needs and interests of older adults. There is a growing literature describing senior center participants and benefits to participation, but little is known about those who choose not to participate at a local senior center. This presentation uniquely characterizes non-users of senior centers, based on a sample of community-dwelling adults aged 50+ from seven communities in Massachusetts (N = 9,462). To date, this is the largest data set that describes senior center usage. Most of the sample were women (60%) and in the 60-69 age group (36%). More than three quarters of the sample do not use the local senior center (77%). The most common reasons for non-usage were lack of interest (27%) and not feeling old enough (26%). There are significant differences in reasons of non-usage among age groups and gender (p < .001). Younger age groups’ (50-69) most popular reasons for non-usage were not feeling old enough, not having time, inconvenient senior center hours, and not knowing what is offered. In contrast, older age groups (80+) more frequently reported having no interest or using programs elsewhere. Men were more likely to report not being interested and not being familiar with what is offered. Women were more likely to report not having time, inconvenient hours of programming, and using programs elsewhere. Based on results from this study, this presentation will outline implications for the future of senior centers and their programming.

scholarly journals Efficacy and Safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three doses combination

2021 ◽  
Author(s):  
Maria Eugenia Toledo-Romani ◽  
Mayra Garcia-Carmenate ◽  
Carmen Valenzuela Silva ◽  
Waldemar Baldoquin-Rodriguez ◽  
Marisel Martinez Perez ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Placebo Group ◽  
Conjugate Vaccine ◽  
Neutralizing Antibodies ◽  
Phase 1 ◽  
Dose Schedule ◽  
T Cell Response ◽  
Group 14 ◽  
Phase 3 ◽  
Double Blinded

Background: SOBERANA 02 is a COVID19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phase 1 and 2 clinical trials demonstrated its high immunogenicity, promoting neutralizing IgG together with specific T-cell response. A third dose of SOBERANA Plus (SARS-CoV-2 RBD-dimer) further increased the specific anti-RBD neutralizing antibodies. Methods: In a randomized, double-blinded, placebo-controlled, phase 3 trial we randomly assigned 44 031 participants, aged 19-80 years to three groups in a 1:1:1 ratio to receive 28 days apart either a) two doses of 25 microg SOBERANA 02, or b) two doses of 25 microg SOBERANA 02 followed by a third dose of 50 microg SOBERANA Plus, or c) two doses of placebo. Reported study endpoints are vaccine efficacy (VE) evaluated through laboratory-confirmed symptomatic COVID-19 cases and safety. During the trial, the SARS CoV-2 isolates in Havana were predominantly (beta 74.0 %) and shift gradually to delta (100%). Results: Two doses of SOBERANA 02 protects against symptomatic COVID-19: 43 cases in the two-dose group (14 371) vs. 155 in the placebo group (14 403), VE 71.0%, adjusted (CI 95%58.9-79.1). The heterologous three dose combination with SOBERANA Plus protected against symptomatic COVID-19: 15 cases in the vaccine groups (13 833) vs. 155 in the placebo group (14 303), VE 92.4%, adjusted (CI 95% 86.9-95.6%). For two-dose schedule VE against severe COVID-19 was 63.0% and for death 59.0%; for heterologous three-dose schedule, 100% in both cases. Conclusions: This is the first phase 3 study of a three-dose, heterologous vaccine combination against SARS-CoV-2. Two doses of the conjugate vaccine SOBERANA 02 was safe and attained efficacy of 71.0% in adults population 19-80 y/o; incorporating SOBERANA Plus after two doses of SOBERANA 02, increased efficacy from 71.0 % to 92.4% (Clinical Trials IFV/COR/09 number, RPCEC00000354.)

scholarly journals Aging Reduces EEG Markers of Recognition Despite Intact Performance: Implications for Forensic Memory Detection

2020 ◽  
Author(s):  
Robin Hellerstedt ◽  
Arianna Moccia ◽  
Chloe M. Brunskill ◽  
Howard Bowman ◽  
Zara M. Bergström
Keyword(s):  
Older Adults ◽  
Temporal Variability ◽  
Brain Activity ◽  
Age Groups ◽  
Older Age ◽  
Practical Applications ◽  
Younger Age ◽  
Behavioural Performance ◽  
Older Populations

AbstractERP-based forensic memory detection is based on the logic that guilty suspects will hold incriminating knowledge about crimes they have committed, and therefore should show parietal ERP positivities related to recognition when presented with reminders of their crimes. We predicted that such forensic memory detection might however be inaccurate in older adults, because of changes to recognition-related brain activity that occurs with aging. We measured both ERPs and EEG oscillations associated with episodic old/new recognition and forensic memory detection in 30 younger (age < 30) and 30 older (age > 65) adults. EEG oscillations were included as a complementary measure which is less sensitive to temporal variability and component overlap than ERPs. In line with predictions, recognition-related parietal ERP positivities were significantly reduced in the older compared to younger group in both tasks, despite highly similar behavioural performance. We also observed ageing-related reductions in oscillatory markers of recognition in the forensic memory detection test, while the oscillatory effects associated with episodic recognition were similar across age groups. This pattern of results suggests that while both forensic memory detection and episodic recognition are accompanied by ageing-induced reductions in parietal ERP positivities, these reductions may be caused by non-overlapping mechanisms across the two tasks. Our findings suggest that EEG-based forensic memory detection tests are invalid in older populations, limiting their practical applications.

scholarly journals INTERNET USE AND LONELINESS: CURE OR CAUSE? LONGITUDINAL ANALYSIS OF OLDER ADULTS’ INTERNET USE

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S14-S14
Author(s):  
Elena Hees ◽  
Clemens Tesch-Römer ◽  
Oliver Huxhold
Keyword(s):  
Older Adults ◽  
Structural Equation ◽  
Internet Use ◽  
Age Groups ◽  
The Internet ◽  
Equation Modelling ◽  
Younger Age ◽  
Using Data ◽  
German Ageing Survey ◽  
Two Age Groups

Abstract The internet provides an indispensable platform for social interaction, entertainment and everyday tasks. Especially older adults might benefit from staying engaged online to counteract loneliness. Yet, current research on how internet use effects loneliness still paints a contradictory picture. The current study investigates the longitudinal influence of social internet use forms as opposed to general internet use on loneliness across three years (2014-2017) separately in two age groups (pre-retirement: 40-64 years and post-retirement: 65-85 years), using data from the German Ageing Survey (DEAS). Structural equation modelling shows, that general web use predicts an increase in loneliness in both age-groups. However, contacting friends and family online seems to protect against loneliness over and above the effect of overall internet use, at least for the younger age-group. Therefore, the current study underlines the importance of investigating what exactly people do online instead of seeing the internet as a homogenous tool.

scholarly journals Safety, Tolerability, and Pharmacokinetics (PK) of Posaconazole (POS) Intravenous (IV) Solution and Oral Powder for Suspension in Children With Neutropenia

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S296-S296 ◽  
Author(s):  
Andreas H Groll ◽  
Hisham Abdel-Azim ◽  
Thomas Lehrnbecher ◽  
William Steinbach ◽  
RoseAnn Murray ◽  
...  
Keyword(s):  
Fungal Infections ◽  
Age Groups ◽  
Oral Suspension ◽  
Target Range ◽  
Age Group ◽  
Open Label ◽  
Dose Escalation Study ◽  
Oral Formulations ◽  
Younger Age ◽  
Dose Levels

Abstract Background POS, a triazole antifungal approved for prophylaxis and treatment of adults with invasive fungal infections, is available as an IV solution and 2 oral formulations: an oral suspension and a tablet with improved bioavailability. A novel powder for oral suspension (PFS) has been developed to offer the bioavailability of the tablet in a formulation optimized for weight-based dosing in children. The objective of this study is to evaluate the safety, tolerability, and PK of POS IV and POS PFS in pediatric patients (patients) aged 2 to 17 y with documented or expected neutropenia. Methods This is an ongoing, nonrandomized, multicenter, open-label, sequential dose-escalation study evaluating POS IV and POS PFS. Pts are divided into 2 age groups: 2 to &lt;7 and 7 to 17 y. Each age group includes 2 dose cohorts: 3.5 mg/kg/d and 4.5 mg/kg/d. Patients received 10–28 d of POS initially as IV solution with the option to switch to PFS after 10 d for the remainder of the treatment period. PK sampling was conducted after 7–10 days on each formulation. Target PK exposure was ~90% of patients with Cavg 500–2,500 ng/mL. Cavg is defined as AUC over a dosing interval. Results 57 of 66 patients (86%) who received POS IV were PK evaluable; 35 patients (53%) received POS PFS, of whom 30 (86%) were PK evaluable. Table 1 shows Cavg and proportion in target range of PK-evaluable patients by dose cohort and age group. The safety profiles of POS IV and PFS were similar to those previously reported for adults treated with oral/IV POS. Conclusion POS PFS resulted in lower POS exposure than IV across age groups at both dose levels. POS exposure was substantially lower in the younger age group for both IV and PFS. At 4.5 mg/kg, the patients in this study achieved the predefined target but did not achieve systemic exposures (mean Cavg) comparable to those seen in adults with POS IV or tablet. These results suggest that study of POS IV and PFS dosing &gt;4.5 mg/kg/d is warranted. Disclosures A. H. Groll, Merck Sharp & Dohme: Consultant, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. T. Lehrnbecher, Merck/MSD: Scientific Advisor and Speaker’s Bureau, Speaker honorarium. Astellas: Scientific Advisor and Speaker’s Bureau, Speaker honorarium. Basilea: Scientific Advisor, Consulting fee. Gilead: Investigator, Scientific Advisor and Speaker’s Bureau, Research grant and Speaker honorarium.Pfizer: Speaker’s Bureau, Speaker honorarium. W. Steinbach, Merck: Consultant, Consulting fee. Astellas: Consultant, Consulting fee. Gilead: Consultant, Consulting fee. R. Murray, Merck: Employee, Salary. A. Paschke, Merck: Employee, Salary. E. Mangin, Merck: Employee, Salary. G. A. Winchell, Merck: Research Contractor, Consulting fee. C. J. Bruno, Merck: Employee and Shareholder, Salary and Stock.

A Qualitative Study of Turning Points or Aha! Moments in Older Adults’ Discussions About Organ Donation

2018 ◽  
Vol 28 (3) ◽  
pp. 207-212 ◽  
Author(s):  
Kimberly Downing ◽  
Linda L. Jones
Keyword(s):  
Older Adults ◽  
Qualitative Study ◽  
Organ Donation ◽  
Organ Procurement ◽  
Turning Points ◽  
Age Groups ◽  
Organ Donor ◽  
Younger Age ◽  
Donation Process ◽  
Dialogue Process

Introduction: Older adults (50-70 years old) have lower organ donor registration rates than younger adults. Older adults have different informational needs and donor registration behavior than younger age groups. Objective: The objective of this qualitative study was to understand insights of older adults about organ donation to effectively address the barriers to becoming an organ donor. This study identified turning points as “Aha!” moments that occurred during a dialogue intervention where older adults discussed benefits, barriers, and process to organ donation. Setting and Participants: Dialogues were held with small groups of older adults in 11 communities in a Midwestern organ procurement organization service area. Participants were positive to organ donation, but not registered as an organ donor. Methods/Approach: Qualitative analysis of verbatim comments from the dialogue and a follow-up survey were used to examine turning points or “Aha!” moments of participants’ decision-making about organ donation and organ donor registration. Findings: Twenty-one separate in-depth dialogues were conducted with 198 participants, with mean age of 60.57 years. There were 2757 separate comments coded with 465 of the comments (17%) identified as providing Aha! moments during the dialogue. Three themes include benefits of organ donation (30%), barriers about organ donation (39%), and organ donation process (31%). Discussion: The research identified moments in the dialogue where possible learning about organ donation may have occurred. After participation in the dialogue process, there was an increase in intent to register to be an organ donor, organ donation discussion with family and friends, and organ donor registration.

scholarly journals Life satisfaction and frailty among older adults

2013 ◽  
Vol 1 (3) ◽  
pp. 32 ◽  
Author(s):  
Katarina Wilhelmson ◽  
Emelie Fritzell ◽  
Kajsa Eklund ◽  
Synneve Dahlin-Ivanoff
Keyword(s):  
Older Adults ◽  
Life Satisfaction ◽  
Psychological Health ◽  
Satisfaction With Life ◽  
Age Groups ◽  
Sexual Life ◽  
Partner Relationship ◽  
Frailty Status ◽  
Younger Age ◽  
Perceived Life Satisfaction

Functional and physical impairment are factors believed to lead to declined life satisfaction among older adults. This study aimed to examine life satisfaction among older adults and the influence of frailty. Baseline data from two studies addressing frail older adults aged 80+ in Gothenburg, Sweden, (n=577) were used. Frailty was measured through eight indicators. Life satisfaction was measured with Fugl-Meyer’s instrument LiSat-11. Perceived life satisfaction was rather high within the studied population, with 66% being satisfied with life as a whole. Most life satisfaction items were significantly associated with frailty status, with non-frail participants being satisfied to a higher extent for all items with the exception of financial situation, sexual life and partnership relation. The factors significantly explaining life satisfaction were psychological health, partner relationship, leisure and ADL. This study shows that older adults’ satisfaction with life as a whole is almost as high as in younger age groups. Respondents with higher degree of frailty reported significantly lower degrees of life satisfaction, indicating a possibility to maintain life satisfaction by preventing or delaying the development of frailty.

Pharmaco-kinetics/dynamics (PK/PD) evaluation and individual patient cross-over studies with growth trajectory assessment to adaptively develop ilorasertib.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2563-2563
Author(s):  
Michael L. Maitland ◽  
Manish Sharma ◽  
Binsheng Zhao ◽  
Mark D. McKee ◽  
Sanja Karovic ◽  
...  
Keyword(s):  
Phase 1 ◽  
Homozygous Deletion ◽  
Tumor Burden ◽  
Individual Change ◽  
Open Label ◽  
Label Dose ◽  
Skin Biopsies ◽  
Open Label Trial ◽  
Clinical Trial Information ◽  
Ct Volume

2563 Background: We evaluated PK/PD of the AURK B/VEGFR2 inhibitor ilorasertib. To detect activity in CDKN2A-deficient tumors, we measured changes-in-tumor-burden by CT-volume before, during, and after discontinuation of therapy. Methods: Study 1: open-label, dose-escalation, phase 1 in 58 patients (pts) with advanced solid tumors. Arms I, II, and III assigned: 23 pts (10–180 mg oral QD), 28 pts (40–340 mg oral BID), and 7 pts (8–32 mg i.v. QD), to ilorasertib monotherapy Days 1, 8, and 15 every 28 days. We evaluated PK/PD for validated biomarkers: change-in-diastolic blood pressure (ΔDBP), change-in-plasma [PlGF] (ΔPlGF), and change-in phosphorylated histone H3 (Δ%pHH3) in skin biopsies. Study 2: open-label trial, of 10 solid tumor pts with CLIA-lab-detected CDKN2A disruption. Pts received ilorasertib 250 mg oral BID on same schedule. On CT images collected prior to screening, and ~ study days -7, 49, and 98 individual lesion volumes were determined by central lab semi-automated segmentation algorithms on DICOM files. Pts who tolerated ilorasertib with RECIST-stable disease at day 98 discontinued ilorasertib for 42 days and underwent re-imaging before restarting ilorasertib. Results: Study 1: the DLTs and frequent adverse events reflected VEGFR2 inhibition. PK/PD analysis showed peak VEGFR2 inhibition on ΔDBP and ΔPlGF at lower systemic concentrations than for peak AURKB-inhibition detected with Δ%pHH3. Two pts in Arm II had partial response; one had homozygous deletion of CDKN2Aby FISH. Pre-clinically the CDKN2A-deficient cell lines (OVCAR5, MDA MB 231, A549) were among the most ilorasertib-sensitive. At time of submission, Study II enrolled 10 pts, with 5 evaluable for longitudinal tumor burden assessments. Three pts had sustained negative growth trajectories after ilorasertib therapy; one of these had positive growth after cessation of treatment but restabilization of disease after restarting ilorasertib. Conclusions: The development plan adapted to the in-human PK/PD assessment. We prospectively conducted individual change-in-tumor burden cross-over studies to assess clinically the sensitivity of CDKN2A-deficient tumors. Clinical trial information: NCT02540876 and NCT01110486.

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