scholarly journals Interim Report of a Phase 2 Randomized Trial of a Plant-Produced Virus-Like Particle Vaccine for Covid-19 in Healthy Adults Aged 18-64 and Older Adults Aged 65 and Older

2021 ◽  
Author(s):  
Philipe Gobeil ◽  
Stéphane Pillet ◽  
Annie Séguin ◽  
Iohann Boulay ◽  
Asif Mahmood ◽  
...  
Keyword(s):  
Older Adults ◽  
Single Dose ◽  
Cellular Response ◽  
Controlled Trial ◽  
Adult Population ◽  
Cell Mediated Immunity ◽  
Phase 2 ◽  
Age Cohorts ◽  
Virus Like Particle ◽  
Ifn Γ

The rapid spread of SARS-CoV-2 globally continues to impact humanity on a global scale with rising morbidity and mortality. Despite the development of multiple effective vaccines, new vaccines continue to be required to supply ongoing demand. We report Day 42 interim safety and immunogenicity data from a Phase 2, randomized, placebo-controlled trial in Adults aged 18+ immunized with a virus-like particle vaccine candidate produced in plants displaying SARS-CoV-2 spike glycoprotein (CoVLP) adjuvanted with AS03 (NCT04636697). This report focuses on presenting safety, tolerability and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-γ and IL-4 ELISpot) responses, in Adults aged 18-64 (Adults) and Older Adults aged 65+ (Older Adults). CoVLP adjuvanted with AS03 was well-tolerated and adverse events (AE) were primarily mild or moderate and of transient duration. AEs in Older Adults were more limited than those observed in the Adult population. CoVLP with AS03 induced a significant humoral immune response in both age cohorts. CoVLP with AS03 induced a greater humoral response in Adults than Older Adults after a single dose but this effect was overcome with a second dose when both age cohorts responded with NAb titers that were ~10-fold higher than those in a panel of sera from patients recovering from COVID-19. A single dose of CoVLP with AS03 induced a significant IFN-γ response in both age cohorts; a second dose significantly boosted IFN-γ and IL-4 responses in both age cohorts. Adults generated a stronger IFN-γ and IL-4 cellular response than did Older Adults after one or two doses of AS03-adjuvanted CoVLP. Safety and immunogenicity from Adults with comorbidities as well as final safety and immunogenicity responses after 12 months will be reported upon availability.

scholarly journals Effects of electroacupuncture frequencies on chronic low back pain in older adults: triple-blind, 12-months protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Sarina Francescato Torres ◽  
Ana Carolina Brandt de Macedo ◽  
Mateus Dias Antunes ◽  
Ingred Merllin Batista de Souza ◽  
Francisco Dimitre Rodrigo Pereira Santos ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Trial ◽  
Adult Population ◽  
Control Group ◽  
Supporting Evidence ◽  
Low Back ◽  
Randomized Controlled

Abstract Background Low back pain (LBP) is the most frequent complaint in clinical practice. Electroacupuncture treatment may be effective; however, the supporting evidence is still limited, especially in older adults. Objective The current study is a randomized controlled trial that aims to evaluate the clinical efficacy of electroacupuncture in older adults with LBP. Methods A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific LBP will be randomly assigned into one of five groups: three electroacupuncture groups (low, high, and alternating frequency); one control group; and one placebo group. The electroacupuncture will be applied twice a week (30 min per session) for five weeks. The primary clinical outcome measure will be pain intensity. The secondary outcomes include: quality of pain; physical functioning; perceived overall effect; emotional functionality; patient satisfaction; and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed up after six and 12 months to check the medium- and long-term effects. Discussion Although electroacupuncture is increasingly used to treat LBP, there is no guidance regarding the parameters used, which leads to inconsistent results. Thus, the effect of electroacupuncture (EA) on LBP remains controversial and requires more studies, especially in the older adult population. Conclusion This is the first randomized controlled trial to evaluate the efficacy of different frequencies of electroacupuncture for treating chronic LBP in older adults. This study will provide evidence on the effectiveness of electroacupuncture as an alternative treatment method for LBP and will entail wider debate about an appropriate acupuncture intervention in this population. Trial registration Clinicaltrials.gov, NCT03802045. Registered on 14 January 2019.

scholarly journals Impact of the HOP-UP-PT program on older adults at risk to fall: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sara K. Arena ◽  
Christopher M. Wilson ◽  
Lori Boright ◽  
Edward Peterson
Keyword(s):  
Older Adults ◽  
At Risk ◽  
Fall Risk ◽  
Care Delivery ◽  
Controlled Trial ◽  
Adult Population ◽  
Risk Indicators ◽  
Control Group ◽  
Senior Centers ◽  
Link Type

Abstract Background Reduced falls and fall risks have been observed among older adults referred to the HOP-UP-PT (Home-based Older Persons Upstreaming Prevention-Physical Therapy) program. The purpose of this study was to describe outcomes of HOP-UP-PT program participants and then to compare these outcomes to non-participants. Methods Six Michigan senior centers referred adults ≥65 years who were at-risk for functional decline or falls. 144 participants (n = 72 per group) were randomized to either the experimental group (EG) or the control group (CG). Physical therapists (PTs) delivered physical, environmental, and health interventions to the EG over nine encounters (six in-person, three telerehabilitation) spanning seven months. The CG participants were told to continue their usual physical activity routines during the same time frame. Baseline and re-assessments were conducted at 0-, 3-, and 7-months in both groups. Descriptions and comparisons from each assessment encounter were analyzed. Results Participants ages were: EG = 76.6 (7.0) years and CG = 77.2 (8.2). Baseline measures were not significantly different apart from the Short Physical Performance Battery (SPPB) which favored the EG (P = 0.02). While no significant differences were identified in the survey outcomes or home environment assessments, significant differences in favor of the EG were identified in common fall risk indicators including the Timed Up and Go (P = 0.04), Four Test Balance Scale (P = 0.01), and the modified SPPB (P = 0.02) at the 3-month assessment visit. However, these differences were not sustained at the 7-month assessment as, notably, both groups demonstrated positive improvements in the Four Test Balance Score and SPPB. For individuals at a moderate/high fall risk at baseline, 47.8% of CG reported falling at seven months; whereas, only 6.3% of EG participants meeting the same criteria reported a fall after HOP-UP-PT participation. Conclusions A prevention-focused multimodal program provided by PTs in older adults’ homes proved beneficial and those with the highest fall risk demonstrated a significant decrease in falls. A collaboration between PTs and community senior centers resulted in upstreaming care delivery that may reduce both the financial and personal burdens associated with falls in an older adult population. Trial registration This study was retrospective registered at Clinical Trials.gov, TRN: NCT04814459 on 24/03/2021.

scholarly journals Bivalent Norovirus VLP Vaccine Candidate in Older Adults: Impact of MPL and a Second Dose in a Randomized, Controlled, Double-Blind Clinical Trial

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S418-S418
Author(s):  
Jim Sherwood ◽  
Jakob Cramer ◽  
Nancy Bouveret Le Cam ◽  
Stella Lin ◽  
Frank Baehner ◽  
...  
Keyword(s):  
Older Adults ◽  
Vaccine Candidate ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Age Groups ◽  
Vaccine Dose ◽  
Healthy Adults ◽  
Cell Mediated Immunity ◽  
Double Blind ◽  
Monophosphoryl Lipid A

Abstract Background Acute norovirus (NoV) gastroenteritis may cause significant morbidity in healthy adults and can prove fatal in older subjects. We investigated the safety and immunogenicity in older adults of one or two doses of an intramuscular bivalent virus-like particle (VLP) vaccine candidate (genotypes GI.1 and multivalent consensus GII.4c) formulated with alum and with and without MPL (3-O-deacyl-4′-monophosphoryl lipid A) adjuvant. Methods In a phase II, double-blind, controlled trial, 294 healthy adults 
≥ 60 years of age randomized to 4 equal groups received one or two immunizations 28 days apart. One dose groups received placebo (saline) on Day 1. Vaccine formulations contained 500μg Al(OH)3adjuvant with 15μg GI.1 and 50μg GII.4c VLP antigens, with or without 15μg MPL adjuvant. A fifth group of 26 healthy 18–49 year-olds received one dose of MPL-free vaccine. Humoral immunity was assessed as ELISA pan-Ig and histo-blood group antigen blocking (HBGA) antibody titers at Days 1, 8, 29 and 57. Cell-mediated immunity (CMI) and avidity indices (AI) were also measured. Safety was assessed as solicited local and systemic adverse events (AE) for 7 days, and unsolicited AEs until Day 28 after each vaccination. Results Marked increases in pan-Ig and HBGA to both genotypes occurred by Day 8 after first vaccination. Geometric mean titers were similar in magnitude in all groups and persisted at similar levels through Day 56. No increases were observed with a second vaccine dose on Day 29 or with the formulations containing MPL. Responses were similar in magnitude when assessed by age groups (60–74, 75–84 and ≥ 85 years of age) and when compared with those to a single vaccine dose in 18–49 year-olds. No clinically relevant differences in CMI responses or changes in antibody avidity were observed between formulations. Both formulations were generally well tolerated, the most frequent reaction being mild pain at the injection site. No vaccine-related SAEs were reported. Conclusion Older adults aged over 60 years displayed immune responses to NoV VLP vaccines that were similar to those in younger adults with no apparent signs of immunosenescence. These data support the further development of the MPL-free vaccine candidate in older adults. Disclosures J. Sherwood, Takeda Pharmaceuticals International AG: Employee, Salary; J. Cramer, Takeda Pharmaceuticals International AG: Employee, Salary; N. Bouveret Le Cam, Takeda Vaccines Inc.: Employee, Salary; S. Lin, Takeda Vaccines Inc.: Employee, Salary; F. Baehner, Takeda Pharmaceuticals International AG: Employee, Salary; P. Mendelman, Takeda Vaccines Inc.: Employee, Salary; A. Borkowski, Takeda Pharmaceuticals International AG: Employee, Salary

Immunomodulation of ALT-2 and TLR may collude in antigen specific T cell hyporesponsiveness: Proposed mechanism for elevated IL-10 levels in Balb/C mice

2014 ◽  
Vol 59 (1) ◽  
Author(s):  
Ramanathan Aparnaa ◽  
Perumal Kaliraj
Keyword(s):  
Cellular Response ◽  
High Titer ◽  
Cell Mediated Immunity ◽  
Control Groups ◽  
Igg Antibody ◽  
Th1 Cytokine ◽  
Protection Efficacy ◽  
Ifn Γ ◽  
High Level

AbstractALT-2, a novel antigen belonging to the chromadorea ALT-2 family of the filarial nematode is proved to clear filarial parasites in Jirds. In order to increase the protection efficacy by stimulating the cell mediated immunity, MPLA a detoxified derivative of LPS known to induce the cellular response, was used in this study as an adjuvant on mice models. ALT-2+MPLA formulation elicited a high titer of total IgG antibody, with profoundly increased levels of IgG2b. Reduced splenocyte proliferation was observed in immunized group when compared to control groups which could be attributed to many in vivo factors. The levels of IFN-γ were high in unstimulated MPLA group compared to ALT-2 stimulated MPLA group, suggesting that the ALT-2 antigen suppressed the IFN-γ levels. A high level of IL-10 was induced by the ALT-2+MPLA formulation, which inhibited the production of Th2 cytokines (IL-4, IL-5) and also reduced the Th1 cytokine (IFN-γ, IL-2) levels which are not in vogue with the classical MPLA adjuvant formulation. We propose a mechanism for this immunomodulation which involves a diminished expression of TLR-4, by which the filarial parasites have evolved to evade host immune mechanism.

scholarly journals A Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In Mice

2020 ◽  
Author(s):  
Ruklanthi de Alwis ◽  
Esther S Gan ◽  
Shiwei Chen ◽  
Yan Shan Leong ◽  
Hwee Cheng Tan ◽  
...  
Keyword(s):  
Single Dose ◽  
Intracellular Cytokine Staining ◽  
Neutralizing Antibody ◽  
Cell Mediated Immunity ◽  
Spike Glycoprotein ◽  
T Helper Lymphocytes ◽  
Antibody Titers ◽  
Replicase Complex ◽  
Ifn Γ ◽  
Dose Vaccine

ABSTRACTA self-transcribing and replicating RNA (STARR™) based vaccine (LUNAR®-COV19) has been developed to prevent SARS-CoV-2 infection. The vaccine encodes an alphavirus-based replicon and the SARS-CoV-2 full length spike glycoprotein. Translation of the replicon produces a replicase complex that amplifies and prolong SARS-CoV-2 spike glycoprotein expression. A single prime vaccination in mice led to robust antibody responses, with neutralizing antibody titers increasing up to day 60. Activation of cell mediated immunity produced a strong viral antigen specific CD8+ T lymphocyte response. Assaying for intracellular cytokine staining for IFN-γ and IL-4 positive CD4+ T helper lymphocytes as well as anti-spike glycoprotein IgG2a/IgG1 ratios supported a strong Th1 dominant immune response. Finally, single LUNAR-COV19 vaccination at both 2 μg and 10 μg doses completely protected human ACE2 transgenic mice from both mortality and even measurable infection following wild-type SARS-CoV-2 challenge. Our findings collectively suggest the potential of Lunar-COV19 as a single dose vaccine.

Medication Adherence in New Zealand Older Adults: Effects of an External Cognitive Support

2005 ◽  
Vol 11 (2) ◽  
pp. 69-83
Author(s):  
June Greyvenstein ◽  
Nikolaos Kazantzis ◽  
Nancy A. Pachana
Keyword(s):  
Older Adults ◽  
New Zealand ◽  
Medication Adherence ◽  
Older Adult ◽  
Controlled Trial ◽  
Adult Population ◽  
Community Dwelling ◽  
Cognitive Support ◽  
Present Sample ◽  
Randomised Controlled

Pharmacotherapy is the most frequently used treatment modality among the older adult population. Consequently, medication adherence represents an important treatment consideration. The present study was conducted to assess the extent of medication adherence in the New Zealand sample, and evaluate the effectiveness of an external cognitive support in a sample of 50 community-dwelling older adults (M = 70.70, Mdn = 72.00, SD = 8.12). A randomised controlled trial to compare the usual medication practice with a medication calendar was conducted. The present sample had high levels of medication adherence, with high adherence measured on an adherence ratio 97% (range 82% to 109%), and low rate of medication errors (19 errors). There were no significant differences in medication adherence between intervention and control groups (ps > .05). However, consistent with prior research, there was some evidence to suggest that female participants were less compliant and made more errors than male participants. Further research on larger more representative older adult samples is warranted.

scholarly journals Cryptosporidium parvum-Specific CD4 Th1 Cells from Sensitized Donors Responding to Both Fractionated and Recombinant Antigenic Proteins

2004 ◽  
Vol 72 (3) ◽  
pp. 1306-1310 ◽  
Author(s):  
Maria Angeles Gomez Morales ◽  
Raffaella Mele ◽  
Alessandra Ludovisi ◽  
Fabrizio Bruschi ◽  
Fabio Tosini ◽  
...  
Keyword(s):  
T Cell ◽  
Cryptosporidium Parvum ◽  
Cellular Response ◽  
Mononuclear Cells ◽  
Early Stage ◽  
T Cell Response ◽  
Interleukin 4 ◽  
Cell Mediated Immunity ◽  
Human T Cell ◽  
Ifn Γ

ABSTRACT T-cell-mediated immunity plays a central role in the host response to Cryptosporidium parvum. Human T-cell clones (TCC) were isolated from peripheral blood mononuclear cells of five healthy donors with prior cryptosporidiosis by use of a C. parvum crude extract, two antigen fractions obtained by ion-exchange chromatography (IEC1 and IEC2), and two recombinant peptides (SA35 and SA40) from C. parvum sporozoites. The T-cell lines derived from the one recently infected donor had a higher proportion (26 to 38%) of T cells exhibiting the γ/δ T-cell receptor (γ/δ-TCR) than those from donors who had recovered from cryptosporidiosis several years earlier, suggesting that the γ/δ T-cell population is involved in the early stage of the infection. The specific TCC had the α/β-TCR, had the phenotype CD45RO+ CD4+ CD8−, and were characterized by either hyperproduction of gamma interferon (IFN-γ) alone, with a Th1 profile, or IFN-γ hyperproduction together with interleukin-4 (IL-4) or IL-5 production, with a Th0 profile. SA35, SA40, IEC1, and IEC2 may be considered good targets of the cellular response against C. parvum and may play a role in maintaining the T-cell-mediated memory response to this parasite. Furthermore, the SA35 and SA40 peptides may be regarded as immunodominant antigens involved in the maintenance of the T-cell response in healthy C. parvum-sensitized persons.

scholarly journals THE INTERNET IS A BOY’S CLUB?: ANALYZING GENDER DIFFERENCES IN COMPUTER & INTERNET ADOPTION BY OLDER ADULTS

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S862-S862
Author(s):  
Derek A Wilson
Keyword(s):  
Older Adults ◽  
Older Adult ◽  
Generation X ◽  
New Technologies ◽  
Adult Population ◽  
Modern Technology ◽  
Previous Literature ◽  
Adult Women ◽  
Adult Age ◽  
Age Cohorts

Abstract The realization of technology’s exponential advancement has been noted in recent years. With ever advancing technologies becoming more integrated in our everyday lives, we must adapt and learn to utilize these new technologies in order to maintain a presence in society. One group that has been stereotyped as struggling to adopt and learn the processes involved with advancing technologies is that of the older adult population. However, previous literature tends to suggest that there are also gendered differences in the adoption of different forms of modern and advancing technologies among older adults. While some articles state that older adult women have been reported to use social media than their male counterparts, conflicting previous literature states that older adult women use newer technologies less, but are more creative in their uses. With these conflicting reports, there comes a need for proper analyses on the gendered use of modern technology among older adults. Using data from the 2015 Current Population Survey (CPS) Computer and Internet Use Supplement, different demographic factors are analyzed for influences on use of technologies. The older adult age cohorts analyzed include the Baby Boomer and the Silent Generation age cohorts. This analysis includes of controlling for additional factors such as regional residence, educational attainment, and other social location variables. Contrary to much of the existing literature, there is little difference in the adoption of computer and internet technologies by older adults. Additionally, the analyses are performed on the Generation X and Millennial age cohorts for comparison.

scholarly journals Relative Fat Mass (RFM) as an Estimate of Total Adiposity in Older Adults

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 51-51
Author(s):  
Katelyn Senkus ◽  
Kristi Crowe-White ◽  
Julie Locher ◽  
Jamy Ard
Keyword(s):  
Older Adults ◽  
Lifestyle Intervention ◽  
Body Fat ◽  
Fat Mass ◽  
Disease Risk ◽  
Controlled Trial ◽  
Adult Population ◽  
Energy Restriction ◽  
Whole Body ◽  
Fat Percentage

Abstract Objectives It is imperative to accurately estimate whole body fat percentage (%fat) in order to understand the deleterious nature of excess adiposity on cardiometabolic disease risk. However, cost and accessibility often preclude the use of advanced assessment methods. Relative fat mass (RFM), an emerging estimator of whole body %fat based upon waist circumference, height, and biological sex, has yet to be evaluated in an older adult population. The purpose of this study was to examine the relationship between RFM and gold standard measures of adiposity among older adults, and to evaluate whether changes in RFM reflected changes in %fat following a 12-month lifestyle intervention. Methods This study was ancillary to a randomized controlled trial investigating the effects of a lifestyle intervention with and without intentional energy restriction. (Clinicaltrials.gov #NCT00955903). Older adults with obesity (N = 163, 37.4% male, 70.3 ± 4.7 years) were randomized to one of three groups: exercise only, exercise + nutrient-dense weight maintenance diet, or exercise + nutrient-dense energy restriction of 500 kcal/d. Total and regional adiposity were determined by dual-energy X-ray absorptiometry (DXA) at baseline and 12 months. Data were analyzed using Spearman's correlations, Wilcoxon, Kruskal-Wallis, and linear regression tests. Results At baseline, significant correlations were observed between RFM and DXA whole body %fat (r = 0.751, P < 0.001), DXA total fat (r = 0.353, P < 0.001), and DXA trunk %fat (r = 0.661, P < 0.001). Additionally, RFM was a significant predictor of DXA whole body %fat (P < 0.001) and accounted for 63.5% of model variance. From baseline to 12 months, a significant reduction in RFM was observed among participants in the exercise only and exercise + energy restriction groups (P = 0.020, P < 0.001, respectively). Magnitude of RFM change did not differ among groups. Notably, changes in RFM were significantly correlated with changes in DXA whole body %fat (r = 0.279, P = 0.001) and DXA trunk %fat (r = 0.276, P = 0.001). Conclusions Results support use of RFM as an estimate of whole body %fat, as well as an indicator of its sensitivity to change in fat mass over 12 months in older adults. Incorporation of RFM in cardiometabolic research may provide meaningful information not reflected in conventional body composition measures such as body mass index. Funding Sources NIH

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