scholarly journals Pneumococcal conjugate vaccination schedules in infants—acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Grant A. Mackenzie ◽  
Isaac Osei ◽  
Rasheed Salaudeen ◽  
Ousman Secka ◽  
Umberto D’Alessandro ◽  
...  
Keyword(s):  
Yellow Fever ◽  
Field Trial ◽  
Yellow Fever Vaccine ◽  
Large Field ◽  
Individual Level ◽  
Reduced Dose ◽  
Cluster Randomised ◽  
Vaccine Type ◽  
Alternative Schedule ◽  
The Individual

Abstract Background Pneumococcal conjugate vaccines (PCVs) effectively prevent pneumococcal disease, but the global impact of pneumococcal vaccination is hampered by its cost. The evaluation of reduced dose schedules of PCV includes measurement of effects on immunogenicity and carriage acquisition compared to standard schedules. The relevance and feasibility of trials of reduced dose schedules is greatest in middle- and low-income countries, such as The Gambia, where the introduction of PCV resulted in good disease control but where transmission of vaccine-type pneumococci persists. We designed a large cluster-randomised field trial of an alternative reduced dose schedule of PCV compared to the standard schedule, the PVS trial. We will also conduct a sub-study to evaluate the individual-level effect of the two schedules on carriage acquisition, immunogenicity, and co-administration of PCV with yellow fever vaccine, the PVS-AcqImm trial. Methods PVS-AcqImm is a prospective, cluster-randomised trial of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. alternative ‘1+1’ schedule) compared to three primary doses scheduled at 6, 10, and 14 weeks of age (i.e. standard ‘3+0’ schedule). Sub-groups within the alternative schedule group will receive yellow fever vaccine separately or co-administered with PCV at 9 months of age. The primary endpoints are (a) rate of nasopharyngeal vaccine-type pneumococcal acquisition from 9 to 14 months of age, (b) geometric mean concentration of vaccine-type pneumococcal IgG at 18 months of age, and (c) proportions with yellow fever neutralising antibody titre ≥8 four weeks after administration of yellow fever vaccine. Participants and field staff will not be masked to group allocation while the measurement of laboratory endpoints will be masked. Approximately equal numbers of participants will be resident in each of 28 geographic clusters (14 clusters in alternative and standard schedule groups); 784 enrolled for acquisition measurements and 336 for immunogenicity measurements. Discussion Analysis will account for potential non-independence of measurements by cluster and so interpretation of effects will be at the individual level (i.e. a population of individuals). PVS-AcqImm will evaluate whether acquisition of vaccine-type pneumococci is reduced by the alternative compared to the standard schedule, which is required if the alternative schedule is to be effective. Likewise, evidence of superior immune response at 18 months of age and safety of PCV co-administration with yellow fever vaccine will support decision-making regarding the use of the alternative 1+1 schedule. Acquisition and immunogenicity outcomes will be essential for the interpretation of the results of the large field trial comparing the two schedules. Trial registration International Standard Randomised Controlled Trial Number 72821613.

scholarly journals Pneumococcal Conjugate Vaccination Schedules Acquisition, Immunogenicity and Pneumococcal Conjugate and Yellow Fever Vaccine Co-Administration Study

2021 ◽  
Author(s):  
Grant Austin Mackenzie ◽  
Isaac Osei ◽  
Rasheed Salaudeen ◽  
Ousman Secka ◽  
Umberto D’Alessandro ◽  
...  
Keyword(s):  
Yellow Fever ◽  
Field Trial ◽  
Yellow Fever Vaccine ◽  
Large Field ◽  
Individual Level ◽  
Reduced Dose ◽  
Cluster Randomised ◽  
Vaccine Type ◽  
Alternative Schedule ◽  
The Individual

Abstract Background:Pneumococcal conjugate vaccines (PCV) effectively prevent pneumococcal disease but the global impact of pneumococcal vaccination is hampered by its cost. The evaluation of reduced dose schedules of PCV includes measurement of effects on immunogenicity and carriage acquisition compared to standard schedules. The relevance and feasibility of trials of reduced dose schedules is greatest in middle- and low-income countries, such as The Gambia, where the introduction of PCV resulted in good disease control but where transmission of vaccine-type pneumococci persists. We designed a large cluster-randomised field trial of an alternative reduced dose schedule of PCV compared to the standard schedule, the PVS trial. We will also conduct a sub-study to evaluate the individual-level effect of the two schedules on carriage acquisition, immunogenicity, and co-administration of PCV with yellow fever vaccine, the PVS-AcqImm trial.Methods:PVS-AcqImm is prospective, cluster-randomised trial of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. alternative ‘1+1’ schedule) compared to three primary doses scheduled at 6, 10, and 14 weeks weeks of age (i.e. stardard ‘3+0’ schedule). Sub-groups within the alternative schedule group will receive yellow fever vaccine separately or co-administered with PCV at 9 months of age. The primary endpoints are: a) rate of nasopharyngeal vaccine-type pneumococcal acquisition from 9-14 months of age, b) geometric mean concentration of vaccine-type pneumococcal IgG at 18 months of age, and c) proportions with yellow fever neutralizing antibody titre ≥8 four weeks after administration of yellow fever vaccine. Participants and field staff will not be masked to group allocation while the measurement of laboratory endpoints will be masked. Approximately equal numbers of participants will be resident in each of 28 geographic clusters (14 clusters in alternative and standard schedule groups); 784 enrolled for acquisition measurements and 336 for immunogenicity measurements. Discussion:Analysis will account for potential non-independence of measurements by cluster and so interpretation of effects will be at the individual level (i.e. a population of individuals). PVS-AcqImm will evaluate whether acquisition of vaccine-type pneumococci is reduced by the alternative compared to standard schedule, which is required if the alternative schedule is to be effective. Likewise, evidence of superior immune response at 18 months of age and safety of PCV co-administration with yellow fever vaccine will support decision-making regarding the use of the alternative 1+1 schedule. Acquisition and immunogenicity outcomes will be essential for interpretation of the results of the large field trial comparing the two schedules.Trial registration: International Standard Randomised Controlled Trial Number – 72821613.

scholarly journals A Cluster-randomised, Non-inferiority Trial of the Impact of a Two-dose Compared to Three-dose Schedule of Pneumococcal Conjugate Vaccination in Rural Gambia: the PVS Trial

2021 ◽  
Author(s):  
Grant Austin Mackenzie ◽  
Isaac Osei ◽  
Rasheed Salaudeen ◽  
Ilias Hossain ◽  
Benjamin Young ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Field Trial ◽  
Pneumococcal Disease ◽  
Population Level ◽  
Dose Schedule ◽  
Reduced Dose ◽  
Pneumococcal Carriage ◽  
Cluster Randomised ◽  
Vaccine Type ◽  
Secondary Endpoints

Abstract Background:Pneumococcal conjugate vaccines (PCV) effectively prevent pneumococcal disease but the global impact of pneumococcal vaccination is hampered by the cost of PCV. The relevance and feasibility of trials of reduced dose schedules is greatest in middle- and low-income countries, such as The Gambia, where PCV has been introduced with good disease control but where transmission of vaccine-type pneumococci persists. We are conducting a large cluster-randomised, non-inferiority, field trial of an alternative reduced dose schedule of PCV compared to the standard schedule, the PVS trial.Methods:PVS is prospective, cluster-randomised, non-inferiority, real-world field trial of an alternative schedule of one dose of PCV scheduled at age 6 weeks with a booster dose at age 9 months (i.e. the alternative ‘1+1’ schedule) compared to the standard schedule of three primary doses scheduled at 6, 10, and 14 weeks weeks of age (i.e. the stardard ‘3+0’ schedule). The intervention will be delivered for 4 years. The primary endpoint is the population-level prevalence of nasopharyngeal vaccine-type pneumococcal carriage in children aged 2 weeks to 59 months with clinical pneumonia in Year 4 of the trial. Participants and field staff are not masked to group allocation while measurement of the laboratory endpoint will be masked. Sixty-eight geographic population clusters have been randomly allocated, in a 1:1 ratio, to each schedule and all resident infants are eligible for enrolment. All resident children less than 5 years of age are under continuous surveillance for clinical safety endpoints measured at 11 health facilities; invasive pneumococcal disease, radiological pneumonia, clinical pneumonia, and hospitalisations. Secondary endpoints include the population-level prevalence of nasopharyngeal vaccine-type pneumococcal carriage in Year 2 and 4 and vaccine-type carriage prevalence in unimmunised infants aged 6-12 weeks in Year 4. The trial includes components of mathematical modeling, health economics, and health systems research.Discussion:Analysis will account for potential non-independence of measurements by cluster, comparing the population-level impact of the two schedules with interpretation at the individual level. The non-inferiority margin is informed by the ‘acceptable loss of effect’ of the alternative compared to standard schedule. The secondary endpoints will provide substantial evidence to support the interpretation of the primary endpoint. PVS will evaluate the effect of transition from a standard 3+0 schedule to an alternative 1+1 schedule in a setting of high pneumococcal transmission. The results of PVS will inform global decision-making concerning the use of reduced-dose PCV schedules.Trial registration: International Standard Randomised Controlled Trial Number – 15056916.

scholarly journals Intradermally Administered Yellow Fever Vaccine at Reduced Dose Induces a Protective Immune Response: A Randomized Controlled Non-Inferiority Trial

PLoS ONE ◽  
2008 ◽  
Vol 3 (4) ◽  
pp. e1993 ◽  
Author(s):  
Anna H. Roukens ◽  
Ann C. Vossen ◽  
Peter J. Bredenbeek ◽  
Jaap T. van Dissel ◽  
Leo G. Visser
Keyword(s):  
Immune Response ◽  
Yellow Fever ◽  
Protective Immune Response ◽  
Yellow Fever Vaccine ◽  
Reduced Dose ◽  
Randomized Controlled

Differential Effects of Competence and Morality on Self-Esteem at the Individual and the Collective Level

2020 ◽  
Vol 51 (3) ◽  
pp. 183-198
Author(s):  
Wiktor Soral ◽  
Mirosław Kofta
Keyword(s):  
Self Esteem ◽  
Differential Effects ◽  
Individual Level ◽  
The Subject ◽  
The Individual

Abstract. The importance of various trait dimensions explaining positive global self-esteem has been the subject of numerous studies. While some have provided support for the importance of agency, others have highlighted the importance of communion. This discrepancy can be explained, if one takes into account that people define and value their self both in individual and in collective terms. Two studies ( N = 367 and N = 263) examined the extent to which competence (an aspect of agency), morality, and sociability (the aspects of communion) promote high self-esteem at the individual and the collective level. In both studies, competence was the strongest predictor of self-esteem at the individual level, whereas morality was the strongest predictor of self-esteem at the collective level.

Metonymy in Dance: Ballet Bunheads Take a Cognitive Turn

2019 ◽  
Vol 37 (1) ◽  
pp. 18-34
Author(s):  
Edward C. Warburton
Keyword(s):  
Identity Formation ◽  
Cognitive Science ◽  
Artistic Development ◽  
Individual Level ◽  
Figures Of Speech ◽  
Self Image ◽  
Level I ◽  
Dance Educators ◽  
The Individual ◽  
Metaphor And Metonymy

This essay considers metonymy in dance from the perspective of cognitive science. My goal is to unpack the roles of metaphor and metonymy in dance thought and action: how do they arise, how are they understood, how are they to be explained, and in what ways do they determine a person's doing of dance? The premise of this essay is that language matters at the cultural level and can be determinative at the individual level. I contend that some figures of speech, especially metonymic labels like ‘bunhead’, can not only discourage but dehumanize young dancers, treating them not as subjects who dance but as objects to be danced. The use of metonymy to sort young dancers may undermine the development of healthy self-image, impede strong identity formation, and retard creative-artistic development. The paper concludes with a discussion of the influence of metonymy in dance and implications for dance educators.

Exploring the effect of weight loss on food reward at the individual level

2019 ◽  
Author(s):  
Pauline Oustric ◽  
Kristine Beaulieu ◽  
Nuno Casanova ◽  
Francois Husson ◽  
Catherine Gibbons ◽  
...  
Keyword(s):  
Weight Loss ◽  
Food Reward ◽  
Individual Level ◽  
The Individual

Personality change and environmental concerns

2020 ◽  
Author(s):  
Christopher James Hopwood ◽  
Ted Schwaba ◽  
Wiebke Bleidorn
Keyword(s):  
Personality Traits ◽  
Personality Change ◽  
Environmental Concerns ◽  
Big Five Personality ◽  
German Population ◽  
Individual Level ◽  
Sustainable Behavior ◽  
Nationally Representative ◽  
The Individual ◽  
Over Time

Personal concerns about climate change and the environment are a powerful motivator of sustainable behavior. People’s level of concern varies as a function of a variety of social and individual factors. Using data from 58,748 participants from a nationally representative German sample, we tested preregistered hypotheses about factors that impact concerns about the environment over time. We found that environmental concerns increased modestly from 2009-2017 in the German population. However, individuals in middle adulthood tended to be more concerned and showed more consistent increases in concern over time than younger or older people. Consistent with previous research, Big Five personality traits were correlated with environmental concerns. We present novel evidence that increases in concern were related to increases in the personality traits neuroticism and openness to experience. Indeed, changes in openness explained roughly 50% of the variance in changes in environmental concerns. These findings highlight the importance of understanding the individual level factors associated with changes in environmental concerns over time, towards the promotion of more sustainable behavior at the individual level.

Reply to Connor and Evers (2020): Critique of the Bias of Crowds Model Simply Restates the Model

2020 ◽  
Author(s):  
Keith Payne ◽  
Heidi A. Vuletich ◽  
Kristjen B. Lundberg
Keyword(s):  
Implicit Bias ◽  
Group Level ◽  
Systemic Racism ◽  
Individual Level ◽  
The Core ◽  
Psychological Science ◽  
Implicit Biases ◽  
The Individual

The Bias of Crowds model (Payne, Vuletich, & Lundberg, 2017) argues that implicit bias varies across individuals and across contexts. It is unreliable and weakly associated with behavior at the individual level. But when aggregated to measure context-level effects, the scores become stable and predictive of group-level outcomes. We concluded that the statistical benefits of aggregation are so powerful that researchers should reconceptualize implicit bias as a feature of contexts, and ask new questions about how implicit biases relate to systemic racism. Connor and Evers (2020) critiqued the model, but their critique simply restates the core claims of the model. They agreed that implicit bias varies across individuals and across contexts; that it is unreliable and weakly associated with behavior at the individual level; and that aggregating scores to measure context-level effects makes them more stable and predictive of group-level outcomes. Connor and Evers concluded that implicit bias should be considered to really be noisily measured individual construct because the effects of aggregation are merely statistical. We respond to their specific arguments and then discuss what it means to really be a feature of persons versus situations, and multilevel measurement and theory in psychological science more broadly.

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