scholarly journals Evaluating Use Cases for Human Challenge Trials in Accelerating SARS-CoV-2 Vaccine Development

2020 ◽  
Author(s):  
Linh Chi Nguyen ◽  
Christopher W Bakerlee ◽  
T Greg McKelvey ◽  
Sophie M Rose ◽  
Alexander J Norman ◽  
...  
Keyword(s):  
Immune Response ◽  
Vaccine Development ◽  
Use Cases ◽  
Stages Of Development ◽  
Challenge Virus ◽  
Vaccine Candidates ◽  
Correlates Of Protection ◽  
Human Immune Response ◽  
Human Immune ◽  
Potential Use

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.

scholarly journals Evaluating use cases for human challenge trials in accelerating COVID-19 vaccine development

2020 ◽  
Author(s):  
Linh Chi Nguyen ◽  
Christopher W Bakerlee ◽  
T Greg McKelvey ◽  
Sophie M Rose ◽  
Alexander J Norman ◽  
...  
Keyword(s):  
Immune Response ◽  
Potential Role ◽  
Vaccine Development ◽  
Use Cases ◽  
Challenge Virus ◽  
Correlates Of Protection ◽  
Practical Guidelines ◽  
Human Immune Response ◽  
Human Immune

Recently, human challenge trials (HCTs) have been proposed as a means to accelerate the development of an effective SARS-CoV-2 vaccine. In this paper, we discuss the potential role for such studies in the current COVID-19 pandemic. First, we present three scenarios in which HCTs could be useful: evaluating efficacy, converging on correlates of protection, and improving understanding of pathogenesis and the human immune response. We go on to outline the practical limitations of HCTs in these scenarios. We conclude that, while currently limited in their application, there are scenarios in which HCTs would be vastly beneficial and, thus, the option of using HCTs to accelerate COVID-19 vaccine development should be preserved. To this end, we recommend an immediate, coordinated effort by all stakeholders to (1) establish ethical and practical guidelines for the use of HCTs for COVID-19; (2) take the first steps toward an HCT, including preparing challenge virus under GMP and making preliminary logistical arrangements; and (3) commit to periodically re-evaluating the utility of HCTs amid the evolving pandemic.

Immune responses during cutaneous and visceral leishmaniasis

Parasitology ◽  
2014 ◽  
Vol 141 (12) ◽  
pp. 1544-1562 ◽  
Author(s):  
LUKASZ KEDZIERSKI ◽  
KRYSTAL J. EVANS
Keyword(s):  
Immune Response ◽  
Immune Responses ◽  
Vaccine Development ◽  
Current Treatment ◽  
Acquired Immunity ◽  
Insect Vector ◽  
Protozoan Parasites ◽  
Human Immune Response ◽  
Human Immune ◽  
Significant Health

SUMMARYLeishmaniaare protozoan parasites spread by a sandfly insect vector and causing a spectrum of diseases collectively known as leishmaniasis. The disease is a significant health problem in many parts of the world, resulting in an estimated 1·3 million new cases and 30 000 deaths annually. Current treatment is based on chemotherapy, which is difficult to administer, expensive and becoming ineffective in several endemic regions. To date there is no vaccine against leishmaniasis, although extensive evidence from studies in animal models indicates that solid protection can be achieved upon immunization. This review focuses on immune responses toLeishmaniain both cutaneous and visceral forms of the disease, pointing to the complexity of the immune response and to a range of evasive mechanisms utilized by the parasite to bypass those responses. The amalgam of innate and acquired immunity combined with the paucity of data on the human immune response is one of the major problems currently hampering vaccine development and implementation.

scholarly journals Assessing the human immune response to SARS-CoV-2 variants

2021 ◽  
Vol 27 (4) ◽  
pp. 571-572 ◽  
Author(s):  
Roberto Burioni ◽  
Eric J. Topol
Keyword(s):  
Immune Response ◽  
Human Immune Response ◽  
Human Immune

scholarly journals Approaches to Modelling the Human Immune Response in Transition of Candidates from Research to Development

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Diane Williamson
Keyword(s):  
Immune Response ◽  
Human Immune Response ◽  
Human Immune ◽  
Animal Rule

This review considers the steps required to evaluate a candidate biodefense vaccine or therapy as it emerges from the research phase, in order to transition it to development. The options for preclinical modelling of efficacy are considered in the context of the FDA’s Animal Rule.

The effects of anabolic steroids and strength training on the human immune response

1989 ◽  
Vol 21 (4) ◽  
pp. 386???392 ◽  
Author(s):  
LEONARD H. CALABRESE ◽  
SUSAN M. KLEINER ◽  
BARBARA P. BARNA ◽  
CHRISTINE I. SKIBINSKI ◽  
DONALD T. KIRKENDALL ◽  
...  
Keyword(s):  
Immune Response ◽  
Strength Training ◽  
Anabolic Steroids ◽  
Human Immune Response ◽  
Human Immune

Development of A First-Responder Fluorescence Reader for Microarray Cytokine Assay of Human Immune Response to Disease

2007 ◽  
Vol 1004 ◽  
Author(s):  
David B. Fenner ◽  
David I Rosen ◽  
Anthony A Ferrante ◽  
Amy E Stevens ◽  
Chad E Bigelow ◽  
...  
Keyword(s):  
Immune Response ◽  
Image Analysis ◽  
Optical Design ◽  
Human Saliva ◽  
Minimally Processed ◽  
Portable Apparatus ◽  
New Apparatus ◽  
Human Immune Response ◽  
Human Immune ◽  
Cytokine Assay

AbstractDevelopment of field portable apparatus and methods for cytokine assay of human saliva by fluorescent-reporting microarray plates is described. Multiplexed assay of 12 cytokines for minimally-processed saliva is read with a CCD-based imager under LED excitation. Immune responsive cytokines are measured at levels significant for indication of human disease state. The motivational context for the new apparatus development, the general optical design issues, saliva protocol, and image analysis are described.

Human Immune Response to a Peptide Mimic ofNeisseria meningitidisSerogroup C in hu-PBMC-SCID Mice

Hybridoma ◽  
1999 ◽  
Vol 18 (2) ◽  
pp. 121-129 ◽  
Author(s):  
WENDY A. HUTCHINS ◽  
THOMAS KIEBER-EMMONS ◽  
GEORGE M. CARLONE ◽  
M.A. JULIE WESTERINK
Keyword(s):  
Immune Response ◽  
Scid Mice ◽  
Peptide Mimic ◽  
Human Immune Response ◽  
Human Immune
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