R. Sheets

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Current advances and challenges in HIV-1 vaccines

J. Bradac, E. Hill, M. Pensiero, 2006, Current HIV/AIDS reports.

Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.

P. Duncan, J. Sadoff, A. Schmidt, 2014, Vaccine.

Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts.

C. Andrews, R. Bailer, Phillip L. Gomez, 2006, Toxicological sciences : an official journal of the Society of Toxicology.

Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.

S. Self, L. Bekker, H. Jaspan, 2008, Journal of acquired immune deficiency syndromes.

Potential use of inflammation and early immunological event biomarkers in assessing vaccine safety.

P. Lambert, H. Golding, I. Gust, 2013, Biologicals : journal of the International Association of Biological Standardization.

Biodistribution of DNA Plasmid Vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile Virus Is Similar, without Integration, despite Differing Plasmid Backbones or Gene Inserts

C. Andrews, G. Nabel, W. Kong, 2006, Toxicological sciences : an official journal of the Society of Toxicology.

Controlled Human Infection Models To Accelerate Vaccine Development

C. Ockenhouse, R. Choy, A. L. Bourgeois, 2022, Clinical Microbiology Reviews.

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

R. Sheets, 2013, Vaccine.

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

R. Sheets, C. Marcus-Sekura, Nandini Sane, 2011, Biologicals.

Human challenge trials in vaccine development: Strasbourg, September 29 - October 1, 2014.

B. Fritzell, R. Sheets, M. T. Aguado de Ros, 2016, Biologicals : journal of the International Association of Biological Standardization.

Gender, age, and ethnicity in HIV vaccine-related research and clinical trials: Report from a WHO–UNAIDS consultation, 26–28 August 2004. Lausanne, Switzerland

J. Fuchs, C. Obermeyer, J. Safrit, 2005, AIDS.

Controlled Human Infection Models To Accelerate Vaccine Development

C. Ockenhouse, R. Choy, A. L. Bourgeois, 2022, Clinical microbiology reviews.

Mechanism of Ad5 Vaccine Immunity and Toxicity: Fiber Shaft Targeting of Dendritic Cells

G. Nabel, J. Gall, W. Kong, 2007, PLoS pathogens.

WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

J. Ledgerwood, D. Kaslow, D. Gutsch, 2020, npj Vaccines.

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

R. Koup, C. Andrews, R. Bailer, 2008, Journal of immunotoxicology.

Recombinant feline leukemia virus genes detected in naturally occurring feline lymphosarcomas

R. Sheets, P. Roy‐Burman, R. Pandey, 1993, Journal of virology.

Adventitious agents in viral vaccines: lessons learned from 4 case studies.

I. Knezevic, E. Griffiths, R. Sheets, 2014, Biologicals : journal of the International Association of Biological Standardization.

Evaluation of cell substrates for the production of biologicals: Revision of WHO recommendations. Report of the WHO Study Group on Cell Substrates for the Production of Biologicals, 22-23 April 2009, Bethesda, USA.

G. Stacey, I. Knezevic, R. Sheets, 2010, Biologicals : journal of the International Association of Biological Standardization.

Preventive Human Papillomavirus (HPV) Vaccines - Background Information Vaccines and Related Biological Products Advisory Committee

Robert W. Anderson, T. Finn, J. Weir, 2001 .

Current advances in HIV vaccines

M. Allen, M. D’Souza, R. Sheets, 2004, Current HIV/AIDS reports.

Nucleotide sequence of yellow fever virus: implications for flavivirus gene expression and evolution.

J. H. Strauss, C. Rice, S. Shin, 1985, Science.

Vaccine Cell Substrates 2004

R. Sheets, J. Petricciani, 2004, Expert review of vaccines.

Workshop Report: Traditional Approach Preventive HIV Vaccines: What Are the Cell Substrate and Inactivation Issues?1

K. Goldenthal, R. Sheets, 1998 .

First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090)

J. Fuchs, S. Kalams, N. Frahm, 2015, Open forum infectious diseases.

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.

J. Mascola, R. Koup, C. Andrews, 2006, The Journal of infectious diseases.

Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

I. Knezevic, R. Sheets, T. Zhou, 2016, Biologicals : journal of the International Association of Biological Standardization.

Biologically selected recombinants between feline leukemia virus (FeLV) subgroup A and an endogenous FeLV element.

C. K. Grant, R. Sheets, V. Klement, 1992, Virology.

Mode of action of adjuvants: implications for vaccine safety and design.

S. Reed, P. Lambert, H. Golding, 2010, Biologicals : journal of the International Association of Biological Standardization.

Communications and Formal Meetings With Regulators: Focusing on the Process Before Clinical Trial Authorization (AKA PRE-IND)

Rebecca Sheets, R. Sheets, 2017 .

Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?

J. K. Pullen, S. Shapiro, V. Mehra, 2015, Vaccine.

Preventive HIV-1 Vaccines

T. Cvetkovich, D. Chandler, K. Goldenthal, 2004 .

Review of efficacy trials of HIV-1/AIDS vaccines and regulatory lessons learned: A review from a regulatory perspective.

I. Knezevic, R. Sheets, T. Zhou, 2016, Biologicals : journal of the International Association of Biological Standardization.

Adventitious agents, new technology, and risk assessment, 19-20 May 2011, Baltimore, MD.

R. Sheets, J. Petricciani, G. Raychaudhuri, 2012, Biologicals : journal of the International Association of Biological Standardization.

Discovery and Development

Rebecca Sheets, R. Sheets, 2017 .

Role of Analytics in Viral Safety

Rebecca L. Sheets, Paul A. Duncan, P. Duncan, 2014, Vaccine Analysis: Strategies, Principles, and Control.

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, I. Knezevic, H. Meyer, 2022, Emerging microbes & infections.

Preclinical Safety and Toxicology

Rebecca Sheets, R. Sheets, 2017 .

WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

J. Ledgerwood, D. Kaslow, D. Gutsch, 2020, npj Vaccines.

An overview of animal cell substrates for biological products.

R. Sheets, J. Petricciani, 2008, Biologicals : journal of the International Association of Biological Standardization.

Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

I. Knezevic, R. Sheets, T. Zhou, 2016, Biologicals : journal of the International Association of Biological Standardization.

Regulatory Aspects of Clinical Trials

R. Sheets, 2017 .