Publications by authors named "Rebecca Sheets"

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

Emerg Microbes Infect· December 2022

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Controlled Human Infection Models To Accelerate Vaccine Development.
Robert K M Choy, A Louis Bourgeois, Christian F Ockenhouse, Richard I Walker, Rebecca L Sheets

Clin Microbiol Rev· September 2022

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WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.
Rebecca Sheets, Hye-Na Kang, Heidi Meyer, Ivana Knezevic,

NPJ Vaccines· June 2020

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Adventitious agents and live viral vectored vaccines: Considerations for archiving samples of biological materials for retrospective analysis.
Bettina Klug, James S Robertson, Richard C Condit, Stephen J Seligman, Marian P Laderoute, Rebecca Sheets

Vaccine· December 2016

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Unique safety issues associated with virus-vectored vaccines: Potential for and theoretical consequences of recombination with wild type virus strains.
Richard C Condit, Anna-Lise Williamson, Rebecca Sheets, Stephen J Seligman, Thomas P Monath

Vaccine· December 2016

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Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.
Rebecca L Sheets, TieQun Zhou, Ivana Knezevic

Biologicals· March 2016

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Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective.
Rebecca L Sheets, TieQun Zhou, Ivana Knezevic

Biologicals· March 2016

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Human challenge trials in vaccine development: Strasbourg, September 29 - October 1, 2014.
Rebecca L Sheets, Bernard Fritzell, M Teresa Aguado de Ros

Biologicals· January 2016

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First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).
Jonathan D Fuchs, Ian Frank, Marnie L Elizaga, Mary Allen, Nicole Frahm, Rebecca Sheets

Open Forum Infect Dis· September 2015

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Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?
Rebecca L Sheets, Vijaya Rangavajhula, Jeffrey K Pullen, Chris Butler, Vijay Mehra

Vaccine· April 2015

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WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.
Ivana Knezevic, Vasee Moorthy, Rebecca Sheets

Vaccine· April 2015

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The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).
Robert T Chen, Baevin Carbery, Lisa Mac, Kenneth I Berns, Louisa Chapman, Rebecca Sheets

Vaccine· January 2015

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Adventitious agents in viral vaccines: lessons learned from 4 case studies.
John Petricciani, Rebecca Sheets, Elwyn Griffiths, Ivana Knezevic

Biologicals· September 2014

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Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.
James Gombold, Stephen Karakasidis, Paula Niksa, John Podczasy, Kitti Neumann, Rebecca L Sheets

Vaccine· May 2014

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Opinion on adventitious agents testing for vaccines: why do we worry so much about adventitious agents in vaccines?
Rebecca L Sheets

Vaccine· June 2013

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Potential use of inflammation and early immunological event biomarkers in assessing vaccine safety.
Béatris Mastelic, David J M Lewis, Hana Golding, Ian Gust, Rebecca Sheets

Biologicals· March 2013

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Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD.
Rebecca Sheets, Johannes Loewer, Gopa Raychaudhuri, John Petricciani

Biologicals· March 2012

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Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products.
Carol Marcus-Sekura, James C Richardson, Rebecca K Harston, Nandini Sane, Rebecca L Sheets

Biologicals· November 2011

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Mode of action of adjuvants: implications for vaccine safety and design.
Béatris Mastelic, Sohail Ahmed, William M Egan, Giuseppe Del Giudice, Hana Golding, Rebecca L Sheets

Biologicals· September 2010

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An overview of animal cell substrates for biological products.
John Petricciani, Rebecca Sheets

Biologicals· November 2008

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Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, or Marburg are similar despite differing adenovirus serotype vector, manufacturer's construct, or gene inserts.
Rebecca L Sheets, Judith Stein, Robert T Bailer, Richard A Koup, Charla Andrews

J Immunotoxicol· July 2008

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Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.
Heather B Jaspan, Coleen K Cunningham, Tim J P Tucker, Peter F Wright, Steve G Self, Rebecca L Sheets

J Acquir Immune Defic Syndr· January 2008

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Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.
Andrew T Catanzaro, Richard A Koup, Mario Roederer, Robert T Bailer, Mary E Enama, Rebecca Sheets

J Infect Dis· December 2006

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Assaying potency of novel vaccines. October 11-12, 2005, Bethesda, MD, USA.
Rebecca Sheets

Expert Rev Vaccines· June 2006

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