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1.
PLoS One ; 17(11): e0275823, 2022.
Article in English | MEDLINE | ID: mdl-36322529

ABSTRACT

In human challenge trials (HCTs), volunteers are deliberately infected with an infectious agent. Such trials can be used to accelerate vaccine development and answer important scientific questions. Starting early in the COVID-19 pandemic, ethical concerns were raised about using HCTs to accelerate development and approval of a vaccine. Some of those concerns pertained to potential exploitation of and/or lack of truly informed consent from volunteers. Specific areas of concern arose around individuals who may be unusually risk-seeking or too economically vulnerable to refuse the payments these trials provide, as opposed to being motivated primarily by altruistic goals. This pre-registered study is the first large-scale survey to characterize people who, early in the pandemic, expressed interest and intention to volunteer to participate in COVID-19 HCTs. We found that individuals expressing interest in SARS-CoV-2 HCTs exhibit consistently altruistic motivations without any special indication of poor risk perception or economic vulnerability. In finding that, early in the pandemic, COVID-19 HCTs were able to attract volunteers whose values align with the nature of these trials, and who are not unusually vulnerable to exploitation, this study may allay some ethical concerns about the volunteers interested in participating in such trials.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Pandemics , Motivation , Volunteers
2.
BMJ Glob Health ; 6(12)2021 12.
Article in English | MEDLINE | ID: mdl-34893478

ABSTRACT

INTRODUCTION: The Global Health Security Index benchmarks countries' capacities to carry out the functions necessary to prevent, detect and respond to biological threats. The COVID-19 pandemic served as an opportunity to evaluate whether the Index contained the correct array of variables that influence countries' abilities to respond to these threats; assess additional variables that may influence preparedness; and examine how the impact of preparedness components change during public health crises. METHODS: Linear regression models were examined to determine the relationship between excess mortality per capita for the first 500 days of countries' COVID-19 pandemic and internal Index variables, as well as external variables including social cohesion; island status; perceived corruption; elderly population size; previous epidemic experience; stringency of non-pharmaceutical interventions; and social and political polarisation. RESULTS: COVID-19 outcomes were significantly associated with sociodemographic, political and governance variables external to the 2019 Index: social cohesion, reduction in social polarisation and reduced perceptions of corruption were consistently correlated with reduced excess mortality throughout the pandemic. The association of other variables assessed by the Index, like epidemiological workforce robustness, changed over time. Fixed country features, including geographic connectedness, larger elderly population and lack of prior coronavirus outbreak experience were detrimental to COVID-19 outcomes. Finally, there was evidence that countries that lacked certain capacities were able to develop these over the course of the pandemic. CONCLUSIONS: Additional sociodemographic, political and governance variables should be included in future indices to improve their ability to characterise preparedness. Fixed characteristics, while not directly addressable, are useful for establishing countries' inherent risk profile and can motivate those at greater risk to invest in preparedness. Particular components of preparedness vary in their impact on outcomes over the course of the pandemic, which may inform resource direction during ongoing crises. Future research should seek to further characterise time-dependent impacts as additional COVID-19 outcome data become available.


Subject(s)
COVID-19 , Aged , Global Health , Humans , Pandemics/prevention & control , SARS-CoV-2 , Social Cohesion
3.
Clin Infect Dis ; 72(4): 710-715, 2021 02 16.
Article in English | MEDLINE | ID: mdl-32628748

ABSTRACT

Human challenge trials (HCTs) have been proposed as a means to accelerate SARS-CoV-2 vaccine development. We identify and discuss 3 potential use cases of HCTs in the current pandemic: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We outline the limitations of HCTs and find that HCTs are likely to be most useful for vaccine candidates currently in preclinical stages of development. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be extremely beneficial. Therefore, the option of conducting HCTs to accelerate SARS-CoV-2 vaccine development should be preserved. As HCTs require many months of preparation, we recommend an immediate effort to (1) establish guidelines for HCTs for COVID-19; (2) take the first steps toward HCTs, including preparing challenge virus and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19 Vaccines , Clinical Trials as Topic , Humans , Pandemics
4.
Autism Res ; 12(8): 1156-1161, 2019 08.
Article in English | MEDLINE | ID: mdl-31132232

ABSTRACT

Research suggests that children with autism spectrum disorder (ASD) may have reduced empathy, as measured by an impaired contagious yawn response, compared to typically developing (TD) children. Other research has failed to replicate this finding, instead attributing this phenomenon to group differences in attention paid to yawn stimuli. A third possibility is that only a subgroup of children with ASD exhibits the impaired contagious yawn response, and that it can be identified biologically. Here we quantified blood concentrations of the "social" neuropeptide oxytocin (OXT) and evaluated yawning behavior and attention rates during a laboratory task in children with ASD (N = 34) and TD children (N = 30) aged 6-12 years. No group difference in contagious yawning behavior was found. However, a blood OXT concentration × group (ASD vs. TD) interaction positively predicted contagious yawning behavior (F1,50 = 7.4987; P = 0.0085). Specifically, blood OXT concentration was positively related to contagious yawning behavior in children with ASD, but not in TD children. This finding was not due to delayed perception of yawn stimuli and was observed whether attention paid to test stimuli and clinical symptom severity were included in the analysis or not. These findings suggest that only a biologically defined subset of children with ASD exhibits reduced empathy, as measured by the impaired contagious yawn response, and that prior conflicting reports of this behavioral phenomenon may be attributable, at least in part, to variable mean OXT concentrations across different ASD study cohorts. Autism Res 2019, 12: 1156-1161. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: People with autism may contagiously yawn (i.e., yawn in response to another's yawn) less often than people without autism. We find that people with autism who have lower levels of blood oxytocin (OXT), a hormone involved in social behavior and empathy, show decreased contagious yawning, but those who have higher blood OXT levels do not differ in contagious yawning from controls. This suggests that decreased contagious yawning may only occur in a biologically defined subset of people with autism.


Subject(s)
Autism Spectrum Disorder/blood , Autism Spectrum Disorder/physiopathology , Empathy/physiology , Oxytocin/blood , Photic Stimulation/methods , Yawning/physiology , Child , Female , Humans , Male , Social Behavior
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