Abstract:
:The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) outbreak that started in Wuhan, China, in 2019 resulted in a pandemic not seen for a century, and there is an urgent need to develop safe and efficacious vaccines. The scientific community has made tremendous efforts to understand the disease, and unparalleled efforts are ongoing to develop vaccines and treatments. Toxicologists and pathologists are involved in these efforts to test the efficacy and safety of vaccine candidates. Presently, there are several SARS-CoV-2 vaccines in clinical trials, and the pace of vaccine development has been highly accelerated to meet the urgent need. By 2021, efficacy and safety data from clinical trials are expected, and potentially a vaccine will be available for those most at risk. This review focuses on the ongoing SARS-CoV-2 vaccine development efforts with emphasis on the nonclinical safety assessment and discusses emerging preliminary data from nonclinical and clinical studies. It also provides a brief overview on vaccines for other coronaviruses, since experience gained from these can be useful in the development of SARS-CoV-2 vaccines. This review will also explain why, despite this unprecedented pace of vaccine development, rigorous standards are in place to ensure nonclinical and clinical safety and efficacy. [Box: see text].
journal_name
Toxicol Patholjournal_title
Toxicologic pathologyauthors
Bennet BM,Wolf J,Laureano R,Sellers RSdoi
10.1177/0192623320959090subject
Has Abstractpub_date
2020-10-01 00:00:00pages
800-809issue
7eissn
0192-6233issn
1533-1601journal_volume
48pub_type
杂志文章,评审abstract::Focal spontaneously occurring eosinophilic hypertrophic cells, histomorphologically resembling oncocytes and hepatocytes, were observed in the pancreas from 11 (0.3%) of 4,177 Sprague-Dawley rats, 3 to 26 months old. The age of these eleven rats ranged from 13 to 25 months. The incidence was not different between sexe...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262338701500101
更新日期:1987-01-01 00:00:00
abstract::The identification, recording, and interpretation of nasal lesions can be a difficult task in toxicology studies. The objective of this article is to provide some guidelines for approaches to nasal toxicologic pathology, based on the author's experience and information available in the published literature. Identifica...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:10.1177/0192623391019004-103
更新日期:1991-01-01 00:00:00
abstract::Regulatory guidelines for nonclinical neurotoxicity testing require spinal cord evaluation but do not specify a trimming scheme. The Society of Toxicologic Pathology (STP) "best practices" for nervous system sampling during nonclinical general toxicity studies recommend that spinal cord be assessed in both longitudina...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623317720120
更新日期:2017-07-01 00:00:00
abstract::Macrophages appearing in lesions are polarized toward M1 (for inflammation) and M2 (for anti-inflammation/fibrosis) types. We analyzed immunophenotypes of macrophages appearing in myocardial lesion in rats injected once with isoproterenol (10 mg/kg body weight). Inflammation following myocardial necrosis on day 1 was ...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623320982526
更新日期:2021-01-05 00:00:00
abstract::Furan is a potent cholangiocarcinogen in rat by an as yet undefined mechanism. The risk to man remains unclear. Using a time-course stop study design, we have investigated the potential of furan to induce oxidative stress and DNA damage associated with inflammatory and regenerative responses in rat liver. Furan was ad...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623309357946
更新日期:2010-02-01 00:00:00
abstract::Ocular medical devices (MDs) represent a very wide and promising field of human ophthalmology. In preclinical studies evaluating the safety and/or performance of these ocular MDs, the choice of histologic technique and the focus of the histopathologic evaluation method should take into consideration the following aspe...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:10.1177/0192623318813533
更新日期:2019-04-01 00:00:00
abstract::Microminipigs have become an attractive animal model for toxicology and pharmacology studies and for human disease models, owing to their manageable size. Although there are numerous reports of spontaneous age-related lesions in mice, rats, dogs, and monkeys, those in minipigs are scarce. In the present study, spontan...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623319861350
更新日期:2019-10-01 00:00:00
abstract::Chronic prostatitis characterized on light microscopic examination by moderate, multifocal, predominantly lymphocytic inflammation associated with epithelial atypia and intranuclear and cytoplasmic inclusion-like material was identified in the prostate gland of 2 Wistar Han rats administered an immunomodulatory test a...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623317713320
更新日期:2017-07-01 00:00:00
abstract::Dogs treated with AR-H047108, an imidazopyridine potassium competitive acid blocker (P-CAB), developed clinical signs of hepatic dysfunction as well as morphologically manifest hepatotoxicity in repeat-dose toxicity studies. An investigative one-month study was performed, with interim euthanasia after one and two week...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623308320802
更新日期:2008-07-01 00:00:00
abstract::With the increasing use of animal-based biomaterials for regenerative medical applications, the need for their safety assessment is paramount. A porcine cholecyst-derived scaffold (CDS), intended as a muscle repair graft, prepared by a nondetergent/enzymatic method was engrafted in a rat abdominal wall defect model. H...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623317752894
更新日期:2018-02-01 00:00:00
abstract::Interrelationships among induction of cytochrome P-450 (CYP) 1A1/2, decrease in connexin 32 (Cx32), and liver tumor-promoting activity by beta-naphthoflavone (BNF) in the promotion stage were examined in a 2-stage liver carcinogenesis model. A total of 20 male Fischer 344 rats were initiated with a single intraperiton...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262330002800406
更新日期:2000-07-01 00:00:00
abstract::Duplications of the gastrointestinal tract are exceedingly rare in laboratory animals. We report a case of a communicating intestinal duplication in a 17-wk-old Sprague-Dawley (SD) rat. The duplication was present in the mesenteric border of the ileum, and both proximal and distal ends were communicated with the lumen...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262339802600216
更新日期:1998-03-01 00:00:00
abstract::A spontaneous multicystic peritoneal mesothelioma was detected in a 108-wk-old male Fischer-344/DuCrj rat. Grossly, a tumor containing numerous, semi-transparent, variously sized, thin-walled cysts was found on the splenic serosal surface. Microscopically, each cyst was surrounded by variable amounts of loose connecti...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262339302100111
更新日期:1993-01-01 00:00:00
abstract::The handling-induced dark neuron is a histological artifact observed in brain samples handled before fixation with aldehydes. To explore associations between dark neurons and immunohistochemical alterations in mouse brains, we examined protein products encoded by Cav3 (neuronal perikarya/neurites), Rbbp4 (neuronal nuc...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623319896263
更新日期:2020-04-01 00:00:00
abstract::Gadolinium is used as a contrast media for magnetic resonance imaging and, experimentally, to block Kupffer cell phagocytosis. In this study, we utilize electron probe microanalysis to determine the subcellular localization of gadolinium chloride (GdCl3) administered to mice in a short-term toxicology study. Male CD-1...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262339602400508
更新日期:1996-09-01 00:00:00
abstract::Our previous studies showed that protein kinase Cepsilon (PKCepsilon) verexpression in mouse skin resulted in metastatic squamous cell carcinoma (SCC) elicited by single 7,12-dimethylbenz(a)anthracene (DMBA)-initiation and 12-O-tetradecanoylphorbol-13-acetate (TPA)-promotion in the absence of preceding papilloma forma...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1080/01926230701748164
更新日期:2007-12-01 00:00:00
abstract::Some developmental dual-acting PPARalpha/gamma agonists, such as ragaglitazar, have shown carcinogenic effects in the rodent urinary bladder urothelium after months-years of dosing. We examined early (precancerous) changes in the bladder urothelium of rats orally dosed with ragaglitazar, using a newly developed flow c...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1080/01926230500214657
更新日期:2005-01-01 00:00:00
abstract::Alloxan-induced diabetic rats frequently exhibit proliferative lesions of squamous hyperplasia accompanied by chronic inflammation and Candida albicans infection in the forestomach, and some lesions progress to squamous cell carcinoma (SCC). Candida infection causes not only hyperplastic changes with inflammation but ...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623309344204
更新日期:2009-10-01 00:00:00
abstract::This overview briefly summarizes the cellular pathobiology of experimental atherosclerosis and is then followed by a consideration of how 3 major risk factors interact with the hypothesized pathogenetic process. First, since hemodynamics and blood flow influence the localization of atherosclerotic plaques, possible me...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:
更新日期:1990-01-01 00:00:00
abstract::One of the biggest challenges in drug development is interpretation of findings suggestive of immunostimulation, particularly when the findings are unexpected based on the known mechanism of action of the drug. Findings suggestive of immunostimulation do not necessarily preclude development of the drug. By understandi...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623313513075
更新日期:2014-10-01 00:00:00
abstract::Toxicologists and pathologists worldwide will benefit from a new, website-based, and completely searchable Nonneoplastic Lesion Atlas just released by the U.S. National Toxicology Program (NTP). The atlas is a much-needed resource with thousands of high-quality, zoomable images and diagnostic guidelines for each roden...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623313517304
更新日期:2014-01-01 00:00:00
abstract::Highly standardized and controlled inhalation studies are required for hazard identification to make test results reproducible and comparable and to fulfill general regulatory requirements for the registration of new drugs, pesticides, or chemicals. Despite significant efforts, the results of inhalation studies have t...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:10.1177/019262330002800514
更新日期:2000-09-01 00:00:00
abstract::In order to investigate the role of the stimulation of cell division for the initiation (and possibly promotion) of liver tumors by chemical carcinogens, the incorporation of radiolabelled thymidine into liver DNA was determined in male rats. Single doses of various levels of aflatoxin B1, benzidine and carbon tetrach...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262338401200118
更新日期:1984-01-01 00:00:00
abstract::Novel biomarkers are often required in the preclinical development of biopharmaceuticals in order to characterize pharmacologic and toxicologic effects and to establish pharmacodynamic and pharmacokinetic relationships. Flow cytometry is uniquely suited for measurement of these biomarkers. Large numbers of single cell...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:10.1177/019262339902700107
更新日期:1999-01-01 00:00:00
abstract::In the context of human hematopathology, the terms myelodysplasia and Myelodysplastic Syndromes (MDS) are applied to disorders of hematopoiesis that are clonal, neoplastic, and, in most forms, manifested as ineffective hematopoiesis with characteristic morphologic abnormalities in multiple cell lines. Studies of human...
journal_title:Toxicologic pathology
pub_type: 杂志文章,评审
doi:10.1080/01926230390177659
更新日期:2003-01-01 00:00:00
abstract::The kerosene-type jet fuel, JP-8, consists of a complex mixture of aliphatic and aromatic hydrocarbons. Because of the utility of JP-8, studies have been conducted to identify the potential long-term consequence of occupational inhalation exposure. Fischer 344 rats and C57BL/6 mice of both sexes were exposed to JP-8 v...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262339101900201
更新日期:1991-01-01 00:00:00
abstract::Liver resection is a suitable option for the treatment of certain hepatic conditions, particularly hepatocarcinomas, in patients with cirrhosis. However, this disease impairs liver regeneration, which increases the risk of liver failure and postoperative death. Supportive treatments for regeneration of the remaining l...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623313486316
更新日期:2014-01-01 00:00:00
abstract::The administration of mesenchymal stromal cells (MSCs) provides an exciting emerging therapeutic modality for the treatment of peripheral arterial disease, a condition that is associated with critical limb ischemia as its end stage. Placental-derived MSCs, termed PLX-PAD cells, are stable adhesive stromal cells isolat...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/0192623309338383
更新日期:2009-08-01 00:00:00
abstract::Systemic hypoxemia, occurring in space-occupying lung pathologies such as inflammation and neoplasms. reduces the gas exchange area and stimulates catecholamine secretion from the adrenal medulla where chronic endocrine hyperactivity may lead to hyperplasia and neoplasia. We investigated the possible correlation betwe...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1080/019262302753559605
更新日期:2002-03-01 00:00:00
abstract::Nedocromil sodium is a nonsteroidal anti-inflammatory drug used to control asthmatic attacks. Our hypothesis is that nedocromil sodium inhibits virus-induced airway inflammation, a common trigger of asthma. We nebulized nedocromil sodium into beagle dogs (n = 10, mean +/- SEM ages: 149 +/- 13 days) before and after in...
journal_title:Toxicologic pathology
pub_type: 杂志文章
doi:10.1177/019262330002800212
更新日期:2000-03-01 00:00:00