scholarly journals Analyses of Safety Profile and Homologous Antibody Responses to a Mammalian Cell-Based, MF59-Adjuvanted, A/H5N1, Pandemic Influenza Vaccine across Four Phase II/III Clinical Trials in Healthy Children, Adults, and Older Adults

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1468
Author(s):  
Eve Versage ◽  
Esther van Twuijver ◽  
Wim Jansen ◽  
Ad Theeuwes ◽  
Daphne Sawlwin ◽  
...  

Modern cell culture-based technology eliminates vaccine manufactures reliance on embryonated chicken eggs, which may become compromised during an avian influenza pandemic. Four studies (total N = 6230) assessed the immunogenicity and safety of mammalian cell-based, MF59®-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ™) as two doses administered on Days 1 and 22 in children (NCT01776554), adults (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330). Immunogenicity of formulations at 7.5 μg and 3.75 μg antigen per dose were assessed by hemagglutination inhibition and microneutralization assays on Days 1, 22, 43, and 183 or 387. Solicited local and systemic adverse events (AEs) were recorded for 7 days after each vaccination. Unsolicited AEs were collected for 21 days after each vaccination, and serious and other selected AEs were recorded for one year. Antibody responses after two 7.5 μg doses met CBER licensure criteria in all age groups. Overall, an age-related response was evident, with the highest responses observed in children <3 years old. In children, antibody titers met seroconversion criteria 12 months after vaccination. MF59 allowed for antigen dose sparing. Solicited AEs were mild to moderate in nature, of short duration, and less frequent after the second dose than the first, demonstrating a favorable risk-benefit profile.

2019 ◽  
Vol 221 (1) ◽  
pp. 33-41 ◽  
Author(s):  
Tiffany W Y Ng ◽  
Ranawaka A P M Perera ◽  
Vicky J Fang ◽  
Emily M Yau ◽  
J S Malik Peiris ◽  
...  

Abstract Background Immune responses to influenza vaccination can be weaker in older adults than in other age groups. We hypothesized that antibody responses would be particularly weak among repeat vaccinees when the current and prior season vaccine components are the same. Methods An observational study was conducted among 827 older adults (aged ≥75 years) in Hong Kong. Serum samples were collected immediately before and 1 month after receipt of the 2015–2016 quadrivalent inactivated influenza vaccine. We measured antibody titers with the hemagglutination inhibition assay and compared the mean fold rise from prevaccination to postvaccination titers and the proportions with postvaccination titers ≥40 or ≥160. Results Participants who reported receipt of vaccination during either of the previous 2 years had a lower mean fold rise against all strains than with those who did not. Mean fold rises for A(H3N2) and B/Yamagata were particularly weak after repeated vaccination with the same vaccine strain, but we did not generally find significant differences in the proportions of participants with postvaccination titers ≥40 and ≥160. Conclusions Overall, we found that reduced antibody responses in repeat vaccinees were particularly reduced among older adults who had received vaccination against the same strains in preceding years.


2019 ◽  
Vol 1 (8) ◽  
pp. 42-50
Author(s):  
A. V. Budkevich ◽  
L. B. Ivanov ◽  
G. R. Novikova ◽  
G. M. Dzhanumova

According to the authors, rationing the age-related EEG parameters in children should be based on personal psychical characteristics. A comparative analysis of personal psychical characteristics and electroencephalographic data was carried out in 300 apparently healthy children aged 3-15 years. According to this principle, two subgroups of conditionally healthy children in each age group were singled out: 1) with an immature attention function and 2) with an increased anxious background that do not reach the pathological level. Registration and analysis of EEG was performed by the Neurokariograf computer complex (MBN, Moscow) using mathematical processing methods.The EEG interpretation was based on the principle of assessing the functional state of a child's brain using a three-component model according to: 1) wakefulness level and its dissociation, 2) severity of signs of the EEG neurotic pattern, 3) directionality of formation of traits of the system-functional brain organization (severity of signs functional hypofrontality).lt was found the presence of EEG signs was indicative of a lower level of wakefulness in children with an immature function of attention in all age groups, compared with the indicators of the average population of group and children with an increased background of anxiety. Children with an increased background of anxiety have a tendency to prevalence and excessive spatial synchronization of the alpha rhythm. ln healthy children, the fact of a decrease in wakefulness and the presence of signs of anxiety in the clinic and in EEG patterns indicates individual personalities and should not be considered as pathology.


PEDIATRICS ◽  
1985 ◽  
Vol 76 (1) ◽  
pp. 91-96
Author(s):  
Heikki Peltola ◽  
Assad Safary ◽  
Helena Käyhty ◽  
Viena Karanko ◽  
Francis E. André

Two different tetravalent polysaccharide vaccines against group A, C, Y, and W135 meningococci were given to 118 infants aged 6 to 23 months; the same vaccines were administered in a second dose 12 months later to those infants aged 6 to 11 months at first vaccination. Forty of the infants received vaccine containing the nonacetylated group C polysaccharide C(OAc-) and 78 the acetylated group C polysaccharide C(OAc+) together with group A, Y, and W135 polysaccharides. All polysaccharides, at a dose of 30 µg, induced antibody responses after administration of both vaccines in all age groups although the responses were better in the older infants. Acetylation of the sialic acid of the group C polysaccharide did not significantly influence the response. Rapid decreases in the antibody titers after the first vaccination stressed the need for one or more revaccinations. Vaccination elicited mild local and systemic reactions. Elevated temperatures were more common in the youngest infants but only four developed fever exceeding 38.5°C (101.3°F). We conclude that tetravalent (ACYW135) meningococcal vaccine is safe and immunologically effective in children younger than age 2 years. However, revaccinations may be required to maintain immunity.


PEDIATRICS ◽  
1981 ◽  
Vol 67 (2) ◽  
pp. 222-229 ◽  
Author(s):  
A. van der Does-van den Berg ◽  
J. Hermans ◽  
J. Nagel ◽  
G. van Steenis

Antibody titers to diphtheria, pertussis, tetanus, and poliomyelitis (types I to III) were measured in previously vaccinated children with acute lymphocytic leukemia in remission after cessation of therapy. The response to revaccination one year after therapy was stopped was also studied. The patients' antibody titers were compared with those of healthy children, matched for age and sex. Two groups of patients were studied: one group (group A, N = 30) was given two drugs (6-mercaptopurine, methotrexate); the other group (group B, N= 19) was given three drugs (6-mercaptopurine, methotrexate, and cyclophosphamide) for maintenance treatment. In general, the patients' antibody titers were lower than those of healthy children, but in most patients they were still at levels considered to be protective. No significant differences in antibody levels between the two patient groups were found. A spontaneous rise in antibody titers in the first year after termination of therapy was not observed. After revaccination the rise in antibody titers was correlated with preexisting antibody titers in the same way in patients as in healthy children, and the antibody titers in patients and in healthy control subjects were on roughly the same level.


2014 ◽  
Vol 30 (4) ◽  
pp. 542-546 ◽  
Author(s):  
Dennis E. Anderson ◽  
Christopher T. Franck ◽  
Michael L. Madigan

The effects of gait speed and step length on the required coefficient of friction (COF) confound the investigation of age-related differences in required COF. The goals of this study were to investigate whether age differences in required COF during self-selected gait persist when experimentally-controlling speed and step length, and to determine the independent effects of speed and step length on required COF. Ten young and 10 older healthy adults performed gait trials under five gait conditions: self-selected, slow and fast speeds without controlling step length, and slow and fast speeds while controlling step length. During self-selected gait, older adults walked with shorter step lengths and exhibited a lower required COF. Older adults also exhibited a lower required COF when walking at a controlled speed without controlling step length. When both age groups walked with the same speed and step length, no age difference in required COF was found. Thus, speed and step length can have a large influence on studies investigating age-related differences in required COF. It was also found that speed and step length have independent and opposite effects on required COF, with step length having a strong positive effect on required COF, and speed having a weaker negative effect.


Author(s):  
Lauren Werner ◽  
Gaojian Huang ◽  
Brandon J. Pitts

The number of older adults is growing significantly worldwide. At the same time, technological developments are rapidly evolving, and older populations are expected to interact more frequently with such sophisticated systems. Automated speech recognition (ASR) systems is an example of one technology that is increasingly present in daily life. However, age-related physical changes may alter speech production and limit the effectiveness of ASR systems for older individuals. The goal of this paper was to summarize the current knowledge on ASR systems and older adults. The PRISMA method was employed and 17 studies were compared on the basis of word error rate (WER). Overall, WER was found to be influenced by age, gender, and the number of speech samples used to train ASR systems. This work has implications for the development of future human-machine technologies that will be used by a wide range of age groups.


Author(s):  
Hyun Gu Kang ◽  
Jonathan B. Dingwell

Older adults commonly walk slower, which many believe helps improve their walking stability. However, they remain at increased risk of falls. We investigated how differences in age and walking speed independently affect dynamic stability during walking, and how age-related changes in leg strength and ROM affected this relationship. Eighteen active healthy older and 17 younger adults walked on a treadmill for 5 minutes each at each of 5 speeds (80–120% of preferred). Local divergence exponents and maximum Floquet multipliers (FM) were calculated to quantify each subject’s responses to small inherent perturbations during walking. These older adults exhibited the same preferred walking speeds as the younger subjects (p = 0.860). However, these older adults still exhibited greater local divergence exponents (p&lt;0.0001) and higher maximum FM (p&lt;0.007) than young adults at all walking speeds. These older adults remained more unstable (p&lt;0.04) even after adjusting for declines in both strength and ROM. In both age groups, local divergence exponents decreased at slower speeds and increased at faster speeds (p&lt;0.0001). Maximum FM showed similar changes with speed (p&lt;0.02). The older adults in this study were healthy enough to walk at normal speeds. However, these adults were still more unstable than the young adults, independent of walking speed. This greater instability was not explained by loss of leg strength and ROM. Slower speeds led to decreased instability in both groups.


2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Catherine M. Mewborn ◽  
Cutter A. Lindbergh ◽  
B. Randy Hammond ◽  
Lisa M. Renzi-Hammond ◽  
L. Stephen Miller

A growing literature emphasizes the importance of lifestyle factors such as nutrition in successful aging. The current study examined if one year of supplementation with lutein (L) and zeaxanthin (Z), two nutrients with known antioxidative properties and cognitive benefits, impacted structural brain outcomes in older adults using a double-blind, randomized, placebo-controlled trial design. Community-dwelling older adults (20 males and 27 females) aged 65–87 years (M = 71.8 years, SD = 6.04 years) were randomized into supplement (N = 33) and placebo groups (N = 14) using simple randomization. The supplement group received 10 mg L + 2 mg Z daily for 12 months while the placebo group received a visually identical, inert placebo. L and Z were measured via retinal concentrations (macular pigment optical density or MPOD). Structural brain outcomes, focusing on global and frontal-temporal lobe regions, were acquired using both T1-weighted and DTI MRI sequences. We hypothesized that the supplement group would increase, maintain, or show attenuated loss in hypothesized regions-of-interest (ROIs) while the placebo group would show age-related declines in brain structural integrity over the course of the trial. While results showed age-related declines for frontal and temporal gray and white matter volumes, as well as fornix white matter microstructure across both groups, only minimal differences were found between the supplement and placebo groups. However, exploratory analyses showed that individuals who responded better to supplementation (i.e., showed greater increases in MPOD) showed less decline in global and prefrontal gray matter volume than supplement “nonresponders.” While results suggest that one year of L and Z supplementation may have limited effects on structural brain outcomes overall, there may be a subsample of individuals for whom supplementation of L and Z provides greater benefits. ClinicalTrials.gov number, NCT02023645.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S841-S842
Author(s):  
Madeline J Nichols ◽  
Jennifer A Bellingtier ◽  
Frances Buttelmann

Abstract Every day we use emotion words to describe our experiences, but past research finds that the meanings of these words can vary. Furthermore, historical shifts in language use and experiential knowledge of the emotions may contribute to age-differences in what these emotion words convey. We examined age-related differences in the valence, arousal, and expression connoted by the words anger, love, and sadness. We predicted age-related differences in the semantic meanings of the words would emerge such that older adults would more clearly differentiate the positivity/negativity of the words, whereas younger adults would report higher endorsement for the conveyed arousal and expression. Participants included American and German older adults (N=61; mean age=68.98) and younger adults (N=77; mean age=20.77). Using the GRID instrument (Swiss Center for Affective Sciences, 2013), they rated each emotion word for its valence, arousal, and expression when used by a speaker of the participant’s native language. Across emotions and dimensions, older adults were generally more moderate in their understanding of emotion words. For example, German older adults rated anger and sadness as suggesting the speaker felt less bad and more good than the younger adults. American older adults rated love as connoting the speaker felt more bad and less good than younger adults. Arousal ratings were higher for German younger, as opposed to older, adults. Cultural differences were most pronounced for sadness such that German participants gave more moderate answers than American participants. Overall, our research suggests that there are age-related differences in the understanding of emotion words.


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027728 ◽  
Author(s):  
Siobhan Leahy ◽  
Marica Cassarino ◽  
Matthew DL O' Connell ◽  
Liam Glynn ◽  
Rose Galvin

IntroductionTwo major global health challenges are the rapidly ageing population and the high prevalence of obesity in all age groups. Older adults are also susceptible to age-related loss of muscle strength, termed dynapaenia. The co-occurrence of both obesity and dynapaenia, termed dynapaenic obesity (DO), has been associated with poorer health outcomes and increased healthcare usage compared with either state alone. The purpose of this systematic review is to quantify the prevalence and incidence of DO in older adult populations, and to explore the association between DO and health outcomes, specifically chronic disease and multimorbidity, functional disability and healthcare usage.Methods and analysisUsing the Meta-analyses Of Observational Studies in Epidemiology guidelines, we will conduct a systematic review of cross-sectional and longitudinal observational studies of older adults, which include measures of DO and specified outcomes. Detailed literature searches of will be conducted using six electronic databases: Excerpta Medica dataBASE (EMBASE), PubMed, MEDLINE, SCOPUS, ScienceDirect and Cumulative Index of Nursing and Allied Health Complete (CINAHL), including articles published from database inception until Febuary 2019. The reference lists of included articles will also be searched. Two independent reviewers will undertake a three-step screening and review process using the Population, Risk Factor, Outcome framework to define eligibility. The Newcastle Ottawa Scale for non-randomised studies will be used to assess risk of bias and to rate study quality. The findings will be synthesised in a narrative summary, and a meta-analysis will be conducted where appropriate.Ethics and disseminationEthical approval is not required for this systematic review. Findings from this research will be submitted for peer-reviewed publication in academic journals, and presented at relevant academic conferences.PROSPERO registration numberCRD42018112471.


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