scholarly journals Human Challenge Studies with Wild Type SARS-CoV-2 Violate Longstanding Codes of Human Subjects Research

2020 ◽  
Author(s):  
Stanley M Spinola ◽  
Camilla Broderick ◽  
Gregory D Zimet ◽  
Mary A Ott
Keyword(s):  
Young Adults ◽  
Vaccine Efficacy ◽  
Human Subjects ◽  
Severe Disease ◽  
Infectious Agents ◽  
Wild Type ◽  
Human Subjects Research ◽  
Nuremberg Code ◽  
Curative Therapy ◽  
Societal Pressure

Abstract This manuscript explores the ethics of human inoculation experiments in young healthy adults with wild type SARS-CoV-2 as a tool to evaluate vaccine efficacy in the context of the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report and in the context of dose response relationships with infectious agents. Despite societal pressure to develop a SARS-CoV-2 challenge model to evaluate vaccines, we argue that there are substantial risks that cannot be adequately defined because the dose of SARS-CoV-2 that causes severe disease in young adults is unknown. In the absence of curative therapy, even if a volunteer consents, longstanding ethical codes governing human subjects research preclude the conduct of such experiments.

scholarly journals Herd immunity induced by COVID-19 vaccination programs to suppress epidemics caused by SARS-CoV-2 wild type and variants in China

2021 ◽  
Author(s):  
Hengcong Liu ◽  
Juanjuan Zhang ◽  
Jun Cai ◽  
Xiaowei Deng ◽  
Cheng Peng ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Disease Burden ◽  
Natural Infection ◽  
Severe Disease ◽  
Herd Immunity ◽  
Data Driven ◽  
Vaccination Program ◽  
Wild Type ◽  
Vaccination Programs ◽  
And Control

To allow a return to a pre-COVID-19 lifestyle, virtually every country has initiated a vaccination program to mitigate severe disease burden and control transmission; over 3.6 billion vaccine doses have been administered as of July 2021. However, it remains to be seen whether herd immunity will be within reach of these programs, especially as more transmissible SARS-CoV-2 variants continue to emerge. To address this question, we developed a data-driven model of SARS-CoV-2 transmission for Shanghai, China, a population with low prior immunity from natural infection. We found that extending the vaccination program to individuals aged 3-17 years plays a key role to reach herd immunity for the original SARS-CoV-2 lineages. With a vaccine efficacy 74% against infection, vaccine-induced herd immunity would require coverages of 93% or higher. Herd immunity for new variants, such as Alpha or Delta, can only be achieved with more efficacious vaccines and coverages above 80-90%. A continuation of the current pace of vaccination in China would reach 72% coverage by September 2021; although this program would fail to reach herd immunity it would reduce deaths by 95-100% in case of an outbreak. Efforts should be taken to increase population's confidence and willingness to be vaccinated and to guarantee highly efficacious vaccines against more transmissible variants of concern.

scholarly journals Protective efficacy of a SARS-CoV-2 DNA vaccine in wild-type and immunosuppressed Syrian hamsters

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Rebecca L. Brocato ◽  
Steven A. Kwilas ◽  
Robert K. Kim ◽  
Xiankun Zeng ◽  
Lucia M. Principe ◽  
...  
Keyword(s):  
Dna Vaccine ◽  
Neutralizing Antibodies ◽  
Protective Efficacy ◽  
Phase 1 ◽  
Severe Disease ◽  
Disease Model ◽  
Wild Type ◽  
Jet Injection ◽  
Syrian Hamsters ◽  
Dna Targeting

AbstractA worldwide effort to counter the COVID-19 pandemic has resulted in hundreds of candidate vaccines moving through various stages of research and development, including several vaccines in phase 1, 2 and 3 clinical trials. A relatively small number of these vaccines have been evaluated in SARS-CoV-2 disease models, and fewer in a severe disease model. Here, a SARS-CoV-2 DNA targeting the spike protein and delivered by jet injection, nCoV-S(JET), elicited neutralizing antibodies in hamsters and was protective in both wild-type and transiently immunosuppressed hamster models. This study highlights the DNA vaccine, nCoV-S(JET), we developed has a great potential to move to next stage of preclinical studies, and it also demonstrates that the transiently-immunosuppressed Syrian hamsters, which recapitulate severe and prolonged COVID-19 disease, can be used for preclinical evaluation of the protective efficacy of spike-based COVID-19 vaccines.

The Patient in Patient Safety: Contemporary Issues, From COVID-19 to Citizen Science

2021 ◽  
Vol 10 (1) ◽  
pp. 301-303
Author(s):  
Elizabeth Lerner Papautsky ◽  
Richard J. Holden ◽  
Rupa S. Valdez ◽  
Jordan Hill ◽  
Janetta Brown
Keyword(s):  
Social Media ◽  
Patient Safety ◽  
Citizen Science ◽  
Human Subjects ◽  
Lessons Learned ◽  
Human Subjects Research ◽  
Research Strategies ◽  
Face To Face

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.

scholarly journals The Association of Malnutrition, illness duration, and pre-morbid weight status with anxiety and depression symptoms in adolescents and young adults with restrictive eating disorders: a cross-sectional study

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Jessica A. Lin ◽  
Grace Jhe ◽  
Julia A. Vitagliano ◽  
Carly E. Milliren ◽  
Rebecca Spigel ◽  
...  
Keyword(s):  
Eating Disorders ◽  
Young Adults ◽  
Weight Status ◽  
Severe Disease ◽  
Anxiety And Depression ◽  
Depression Symptoms ◽  
Comprehensive Treatment ◽  
Psychiatric Medication ◽  
Illness Duration ◽  
Restrictive Eating

Abstract Background Restrictive eating disorders (EDs) are often comorbid with anxiety and depression symptoms, placing patients at risk for more severe disease, worse treatment outcomes, and higher rates of mortality. To identify risks for developing such co-morbidities, we assessed the association of malnutrition, ED illness duration, and pre-morbid weight status with symptoms of anxiety and depression in adolescents/young adults (AYAs) with EDs. Methods 145 participants with restrictive EDs (anorexia nervosa [AN], other specified feeding and eating disorders [OSFED], avoidant restrictive food intake disorder [ARFID]) were included from the RECOVERY study, a longitudinal web-based registry of AYAs with EDs. We measured malnutrition as percent of expected body mass index (%eBMI), based on participants’ pre-morbid growth trajectory. Outcomes were anxiety and depression scores from the Generalized Anxiety Disorder 7-item (GAD-7) and Center for Epidemiologic Studies Depression (CES-D) scales. We used multiple linear regression to examine the association of malnutrition, ED duration, and pre-morbid weight status with symptoms of anxiety and depression. Results Mean (SD) age was 16.4(3.0) years; 87% were female; 89% white; 85% had AN, 6% OSFED, 10% ARFID. Of these, 2/3 had ED symptoms ≥1 year, 1/3 had previous higher level of ED care (HLOC), and half were taking psychiatric medications. Mean %eBMI was 90% (range 57–112%). Mean GAD-7 was 9.4(5.9) and CES-D was 24(13.8), indicating most participants had clinically significant anxiety and/or depression. Degree of malnutrition was not significantly associated with anxiety or depression adjusting for age, sex, sexual orientation, ED diagnosis, and use of psychiatric medication. Those with longer duration of ED symptoms had higher depression scores after adjusting for malnutrition, HLOC, length of ED symptoms, and time in our care (p = 0.038). Patients with pre-morbid BMIs ≥75th percentile had lower depression scores than those with pre-morbid BMIs <75th percentile (p = 0.014). Conclusions We find high degree of clinically relevant anxiety and depression symptoms in a population of AYAs with EDs. Our findings suggest that factors beyond malnutrition play a role in the co-morbid mood and anxiety disorders in this population. Overall, rapid ED diagnosis and comprehensive treatment for patients with EDs across the weight spectrum—and especially those with psychiatric co-morbidities—will likely aid in recovery.

scholarly journals Human Subjects Requirements and Economic Education Researchers

2007 ◽  
Vol 51 (2) ◽  
pp. 49-60 ◽  
Author(s):  
Jane S. Lopus ◽  
Paul W. Grimes ◽  
William E. Becker ◽  
Rodney A. Pearson
Keyword(s):  
Human Subjects ◽  
Economic Education ◽  
Opportunity Costs ◽  
Federal Regulations ◽  
Research Projects ◽  
Human Subjects Research ◽  
Web Based ◽  
American Universities ◽  
Net Benefits ◽  
Low Levels

This paper presents the results of a web-based survey of economic educators who were asked about their knowledge and experience with human subjects research and the mandated federal protocols that govern such research at most American universities. The results indicate that while economic education researchers are experienced in conducting human subjects research and are aware of the federal regulations, they are not well informed about key details of the regulations. They are skeptical of the net benefits of the mandated protocols because of the perceived discouraging burdens of the paperwork that rarely result in significant modifications of their research projects. The authors conclude that recent calls for modifications to the federal regulations for classroom-based research projects may be justified given the opportunity costs of adhering to the regulations compared to the relatively low levels of perceived benefits.

scholarly journals Titers of Neutralizing Antibodies against SARS-CoV-2 Are Independent of Symptoms of Non-Severe COVID-19 in Young Adults

Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 284
Author(s):  
Hulda R. Jonsdottir ◽  
Michel Bielecki ◽  
Denise Siegrist ◽  
Thomas W. Buehrer ◽  
Roland Züst ◽  
...  
Keyword(s):  
Young Adults ◽  
Neutralizing Antibodies ◽  
Severe Disease ◽  
Humoral Response ◽  
Neutralizing Antibody ◽  
Neutralization Assay ◽  
Asymptomatic Infection ◽  
Homogeneous Population ◽  
Humoral Immune ◽  
Antibody Titers

Neutralizing antibodies are an important part of the humoral immune response to SARS-CoV-2. It is currently unclear to what extent such antibodies are produced after non-severe disease or asymptomatic infection. We studied a cluster of SARS-CoV-2 infections among a homogeneous population of 332 predominantly male Swiss soldiers and determined the neutralizing antibody response with a serum neutralization assay using a recombinant SARS-CoV-2-GFP. All patients with non-severe COVID-19 showed a swift humoral response within two weeks after the onset of symptoms, which remained stable for the duration of the study. One month after the outbreak, titers in COVID-19 convalescents did not differ from the titers of asymptomatically infected individuals. Furthermore, symptoms of COVID-19 did not correlate with neutralizing antibody titers. Therefore, we conclude that asymptomatic infection can induce the same humoral immunity as non-severe COVID-19 in young adults.

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