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Book ; Conference proceedings: Vaccine cell substrates 2004

Sheets, Rebecca

National Institutes of Health, Rockville, MD, USA, June 29 - July 1, 2004 ; proceedings of a symposium ; 51 tables

(Developments in biologicals ; 123)

2006

Institution	National Institutes of Health
Author's details	vol. ed. Rebecca Sheets
Series title	Developments in biologicals ; 123
Collection
Keywords	Viral Vaccines ; Cell Culture Techniques ; Cell Transformation, Neoplastic ; Cells, Cultured ; Drug Contamination / prevention & control ; Biologisches Material ; Impfstoff ; Arzneimittelentwicklung
Subject	Arzneimittel ; Drug Development ; Vaccine ; Vakzine ; Antikörperhaltiges Arzneimittel ; Biologische Probe ; Bioprobe ; Biologisches Präparat ; Mikroprobe ; Biologisches Untersuchungsmaterial
Language	English
Size	IX, 363 S., 245 mm x 175 mm
Publisher	Karger
Publishing place	Basel u.a.
Publishing country	Switzerland
Document type	Book ; Conference proceedings
HBZ-ID	HT014651496
ISBN	3-8055-7999-3 ; 978-3-8055-7999-5
Database	Catalogue ZB MED Medicine, Health

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Article ; Online: Mutations in coral soma and sperm imply lifelong stem cell renewal and cell lineage selection.

López-Nandam, Elora H / Albright, Rebecca / Hanson, Erik A / Sheets, Elizabeth A / Palumbi, Stephen R

Proceedings. Biological sciences

2023 Volume 290, Issue 1991, Page(s) 20221766

Abstract: In many animals, the germline differentiates early in embryogenesis, so only mutations that accumulate in germ cells are inherited by offspring. Exceptions to this developmental process may indicate other mechanisms have evolved to limit the effects of ... ...

Abstract	In many animals, the germline differentiates early in embryogenesis, so only mutations that accumulate in germ cells are inherited by offspring. Exceptions to this developmental process may indicate other mechanisms have evolved to limit the effects of deleterious mutation accumulation. Stony corals are animals that can live for hundreds of years and have been thought to produce gametes from somatic tissue. To clarify conflicting evidence about germline-soma distinction in corals, we sequenced high coverage, full genomes with technical replicates for parent coral branches and their sperm pools. We identified post-embryonic single nucleotide variants (SNVs) unique to each parent branch, then checked if each SNV was shared by the respective sperm pool. Twenty-six per cent of post-embryonic SNVs were shared by the sperm and 74% were not. We also identified germline SNVs, those that were present in the sperm but not in the parent. These data suggest that self-renewing stem cells differentiate into germ and soma throughout the adult life of the colony, with SNV rates and patterns differing markedly in stem, soma and germ lineages. In addition to informing the evolution of germlines in metazoans, these insights inform how corals may generate adaptive diversity necessary in the face of global climate change.
MeSH term(s)	Animals ; Male ; Cell Lineage ; Anthozoa/genetics ; Cell Self Renewal ; Semen ; Spermatozoa ; Mutation ; Germ Cells
Language	English
Publishing date	2023-01-18
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	209242-6
ISSN	1471-2954 ; 0080-4649 ; 0962-8452 ; 0950-1193
ISSN (online)	1471-2954
ISSN	0080-4649 ; 0962-8452 ; 0950-1193
DOI	10.1098/rspb.2022.1766
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Article ; Online: WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021.

Liu, Margaret A / Zhou, Tiequn / Sheets, Rebecca L / Meyer, Heidi / Knezevic, Ivana

Emerging microbes & infections

2022 Volume 11, Issue 1, Page(s) 384–391

Abstract: This paper presents the key outcomes of the above WHO informal consultation with global stakeholders including regulatory authorities, vaccine developers and manufacturers, academia and other international health organizations and institutions involved ... ...

Abstract	This paper presents the key outcomes of the above WHO informal consultation with global stakeholders including regulatory authorities, vaccine developers and manufacturers, academia and other international health organizations and institutions involved in the development, evaluation and use of messenger RNA (mRNA) vaccines. The aim of the consultation was to further clarify the main principles to be presented in an upcoming WHO guidance document on the regulatory considerations in evaluating the quality, safety and efficacy of mRNA prophylactic vaccines for infectious diseases. This WHO guidance document is intended to facilitate global mRNA vaccine development and regulatory convergence in the assessment of such vaccines. The urgent need to develop such a document as a new WHO written standard is outlined in this report along with the key scientific and regulatory challenges. A number of key conclusions are provided at the end of this report along with an update on the steps taken following this meeting.
MeSH term(s)	COVID-19/prevention & control ; Communicable Disease Control/methods ; Communicable Diseases/immunology ; Humans ; Vaccine Potency ; Vaccines, Synthetic/adverse effects ; Vaccines, Synthetic/therapeutic use ; World Health Organization ; mRNA Vaccines/adverse effects ; mRNA Vaccines/therapeutic use
Chemical Substances	Vaccines, Synthetic ; mRNA Vaccines
Language	English
Publishing date	2022-01-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2681359-2
ISSN	2222-1751 ; 2222-1751
ISSN (online)	2222-1751
ISSN	2222-1751
DOI	10.1080/22221751.2022.2026742
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Article ; Online: Opinion on adventitious agents testing for vaccines: why do we worry so much about adventitious agents in vaccines?

Sheets, Rebecca L

Vaccine

2013 Volume 31, Issue 26, Page(s) 2791–2795

Abstract: The manner in which viral vaccines are produced in a biological system makes them vulnerable to microbial contamination. Considerable effort is expended to avoid such contamination and to detect it if it occurred. Is this effort warranted, efficient, ... ...

Abstract	The manner in which viral vaccines are produced in a biological system makes them vulnerable to microbial contamination. Considerable effort is expended to avoid such contamination and to detect it if it occurred. Is this effort warranted, efficient, scientifically sound, and rational? When asked for my opinion on these matters, I agreed to discuss the basis and historical context for why we do what we do and proffer opinion on what we might do instead or in addition, as we look forward to the inclusion of new strategies and methods in our arsenal. Being an advocate of the 3 R's policy, I invite a re-examination of the traditional in vivo methods in particular. I also advocate for a risk-based approach consistent with "Quality by Design" as a more scientific and rational means of addressing these issues. In the end, vaccinologists need to reassure the public that the vaccines they or their children receive are safe and pure and that all reasonable measures are taken to safeguard them.
MeSH term(s)	Animals ; Drug Contamination/prevention & control ; Drug Evaluation, Preclinical/methods ; Drug Evaluation, Preclinical/standards ; Humans ; Risk Assessment ; Viral Vaccines/adverse effects
Chemical Substances	Viral Vaccines
Language	English
Publishing date	2013-06-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2013.03.023
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Article ; Online: NTCP modelling of xerostomia after radiotherapy for oropharyngeal cancer using the PRO-CTCAE and CTCAE scoring systems at different time-points post-RT.

Tzikas, Athanasios / Lavdas, Eleftherios / Kehagias, Dimitrios / Amdur, Robert / Mendenhall, William / Sheets, Nathan / Green, Rebecca / Chera, Bhishamjit / Mavroidis, Panayiotis

Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB)

2023 Volume 116, Page(s) 103169

Abstract: Purpose: This study aims at determining the parameter values of three normal tissue complication probability (NTCP) models for the contralateral parotid gland, contralateral submandibular gland (SMG) and contralateral salivary glands regarding the ... ...

Abstract	Purpose: This study aims at determining the parameter values of three normal tissue complication probability (NTCP) models for the contralateral parotid gland, contralateral submandibular gland (SMG) and contralateral salivary glands regarding the endpoint of xerostomia 6-24 months after radiotherapy for oropharynx cancer. Methods: The treatment and outcome data of 231 patients with favorable risk, HPV-associated oropharyngeal squamous cell carcinoma are analyzed. 60 Gy intensity modulated radiotherapy was delivered to all the patients. The presence and severity of xerostomia was recorded (pre- and post- radiotherapy) by the PRO-CTCAE and the CTCAE scoring systems. In both scoring systems, patients with a change in symptom severity (from baseline) of ≥ 2 were considered responders. Results: Xerostomia was observed in 61.3 %, 39.2 %, 28.6 % and 27.0 % of the patients based on the PRO-CTCAE scoring system at 6-, 12-, 18- and 24-months post-RT, respectively. The AUCs of the contralateral salivary glands ranged between 0.58-0.64 in the LKB model with the gEUD ranging between 20.3 Gy and 24.7 Gy. Conclusions: Based on the PRO-CTCAE scores, mean dose < 22 Gy, V50 < 10 % for the contralateral salivary glands and mean dose < 18 Gy, V45 < 10 % for the contralateral parotid were found to significantly reduce by a factor of 2-3 the risk for radiation induced xerostomia that is observed at 6-24 months post-RT, respectively. Also, gEUD < 22 Gy to the contralateral salivary glands and < 18 Gy to the contralateral parotid was found to significantly reduce the risk for radiation induced xerostomia that is observed at 6-24 months post-RT by 2.0-2.3 times.
MeSH term(s)	Humans ; Radiotherapy Dosage ; Xerostomia/etiology ; Xerostomia/diagnosis ; Xerostomia/pathology ; Oropharyngeal Neoplasms/radiotherapy ; Parotid Gland ; Radiotherapy, Intensity-Modulated/adverse effects ; Head and Neck Neoplasms/complications ; Probability
Language	English
Publishing date	2023-11-20
Publishing country	Italy
Document type	Journal Article
ZDB-ID	1122650-x
ISSN	1724-191X ; 1120-1797
ISSN (online)	1724-191X
ISSN	1120-1797
DOI	10.1016/j.ejmp.2023.103169
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Article ; Online: WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.

Sheets, Rebecca / Kang, Hye-Na / Meyer, Heidi / Knezevic, Ivana

NPJ vaccines

2020 Volume 5, Issue 1, Page(s) 52

Abstract: Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this ... ...

Abstract	Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this revision are described, including the need for regulatory convergence highlighted by the WHO R&D Blueprint. These consultations have driven the revision to its current form, where a new guideline that includes quality, nonclinical, and clinical evaluation of plasmid DNA vaccines is being prepared for public consultation with a view to present to an upcoming ECBS. Major changes to the guidelines include streamlining the existing quality (part A) and nonclinical (part B) sections to reflect the two decades of experience, with manufacturing and control, nonclinical evaluation, and clinical testing of plasmid DNA vaccines, as a platform technology. The urgency for gaining regulatory convergence on this topic is that development of such a platform technology as DNA vaccines for routine use immunizations will prepare manufacturers and regulators across the globe in dealing with rapid development of medical countermeasures against emerging infectious diseases even in the face of an emergency setting. Two examples are described of Zika candidate vaccines that have rapidly advanced in development based on preexisting nonclinical and clinical data that precluded the need to repeat nonclinical toxicology. This report describes the progress stemming from the most recent consultation on the guidelines, including topics discussed and consensus reached.
Keywords	covid19
Language	English
Publishing date	2020-06-18
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-020-0197-2
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Article ; Online: Controlled Human Infection Models To Accelerate Vaccine Development.

Choy, Robert K M / Bourgeois, A Louis / Ockenhouse, Christian F / Walker, Richard I / Sheets, Rebecca L / Flores, Jorge

Clinical microbiology reviews

2022 Volume 35, Issue 3, Page(s) e0000821

Abstract: The timelines for developing vaccines against infectious diseases are lengthy, and often vaccines that reach the stage of large phase 3 field trials fail to provide the desired level of protective efficacy. The application of controlled human challenge ... ...

Abstract	The timelines for developing vaccines against infectious diseases are lengthy, and often vaccines that reach the stage of large phase 3 field trials fail to provide the desired level of protective efficacy. The application of controlled human challenge models of infection and disease at the appropriate stages of development could accelerate development of candidate vaccines and, in fact, has done so successfully in some limited cases. Human challenge models could potentially be used to gather critical information on pathogenesis, inform strain selection for vaccines, explore cross-protective immunity, identify immune correlates of protection and mechanisms of protection induced by infection or evoked by candidate vaccines, guide decisions on appropriate trial endpoints, and evaluate vaccine efficacy. We prepared this report to motivate fellow scientists to exploit the potential capacity of controlled human challenge experiments to advance vaccine development. In this review, we considered available challenge models for 17 infectious diseases in the context of the public health importance of each disease, the diversity and pathogenesis of the causative organisms, the vaccine candidates under development, and each model's capacity to evaluate them and identify correlates of protective immunity. Our broad assessment indicated that human challenge models have not yet reached their full potential to support the development of vaccines against infectious diseases. On the basis of our review, however, we believe that describing an ideal challenge model is possible, as is further developing existing and future challenge models.
MeSH term(s)	Clinical Trials, Phase III as Topic ; Communicable Disease Control ; Humans ; Models, Biological ; Vaccine Development ; Vaccines
Chemical Substances	Vaccines
Language	English
Publishing date	2022-07-06
Publishing country	United States
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	645015-5
ISSN	1098-6618 ; 0893-8512
ISSN (online)	1098-6618
ISSN	0893-8512
DOI	10.1128/cmr.00008-21
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Article ; Online ; Conference proceedings: Assaying potency of novel vaccines. October 11-12, 2005, Bethesda, MD, USA.

Sheets, Rebecca

Expert review of vaccines

2006 Volume 5, Issue 3, Page(s) 315–318

MeSH term(s)	AIDS Vaccines/immunology ; Animals ; Dose-Response Relationship, Immunologic ; Enzyme-Linked Immunosorbent Assay/methods ; Humans ; Malaria Vaccines/immunology ; Polymerase Chain Reaction/methods ; Reproducibility of Results ; Tuberculosis Vaccines/immunology
Chemical Substances	AIDS Vaccines ; Malaria Vaccines ; Tuberculosis Vaccines
Language	English
Publishing date	2006-06
Publishing country	England
Document type	Congresses
ZDB-ID	2181284-6
ISSN	1744-8395 ; 1476-0584
ISSN (online)	1744-8395
ISSN	1476-0584
DOI	10.1586/14760584.5.3.315
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Article: Opinion on adventitious agents testing for vaccines: Why do we worry so much about adventitious agents in vaccines?

Sheets, Rebecca L

Vaccine. 2013 June 10, v. 31, no. 26

2013

Abstract	The manner in which viral vaccines are produced in a biological system makes them vulnerable to microbial contamination. Considerable effort is expended to avoid such contamination and to detect it if it occurred. Is this effort warranted, efficient, scientifically sound, and rational? When asked for my opinion on these matters, I agreed to discuss the basis and historical context for why we do what we do and proffer opinion on what we might do instead or in addition, as we look forward to the inclusion of new strategies and methods in our arsenal. Being an advocate of the 3 R's policy, I invite a re-examination of the traditional in vivo methods in particular. I also advocate for a risk-based approach consistent with “Quality by Design” as a more scientific and rational means of addressing these issues. In the end, vaccinologists need to reassure the public that the vaccines they or their children receive are safe and pure and that all reasonable measures are taken to safeguard them.
Keywords	children ; issues and policy ; microbial contamination ; viral vaccines
Language	English
Dates of publication	2013-0610
Size	p. 2791-2795.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2013.03.023
Database	NAL-Catalogue (AGRICOLA)

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Article: Patient and Provider Satisfaction With Pediatric Urology Telemedicine Clinic.

Chrapah, Sandra / Becevic, Mirna / Washington, Karla T / Sheets, Lincoln R / Wallach, Emmanuelle / Chitima, Rebecca / Malm-Buatsi, Elizabeth

Journal of patient experience

2021 Volume 8, Page(s) 2374373520975734

Abstract: The use of telemedicine continues to grow as more patients are receptive to this innovative way of providing health care. Multiple publications in telemedicine indicated high satisfaction for this service. This study focuses on the use of telemedicine in ...

Abstract	The use of telemedicine continues to grow as more patients are receptive to this innovative way of providing health care. Multiple publications in telemedicine indicated high satisfaction for this service. This study focuses on the use of telemedicine in a pediatric urology clinic and examines 3 research questions: (1) How did patients' parents/guardians feel about their video appointments? (2) What were the experiences of novice telemedicine providers conducting postsurgical appointments via video? and (3) How did novice telemedicine providers' experiences compare to those of expert telemedicine providers?
Language	English
Publishing date	2021-01-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2857285-3
ISSN	2374-3743 ; 2374-3735
ISSN (online)	2374-3743
ISSN	2374-3735
DOI	10.1177/2374373520975734
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