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Controlled Human Infection Models To Accelerate Vaccine Development

Clinical microbiology reviews, 2022-09, Vol.35 (3), p.e0000821-e0000821

2022

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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

Emerging microbes & infections, 2022-12, Vol.11 (1), p.384-391

2022

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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines

Sheets, Rebecca

1, 2017

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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

Vaccine, 2014-05, Vol.32 (24), p.2916-2926

2014

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

Vaccine, 2013-06, Vol.31 (26), p.2791-2795

Sheets, Rebecca L

2013

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

Biologicals, 2016-03, Vol.44 (2), p.73-89

2016

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Mechanism of ad5 vaccine immunity and toxicity: fiber shaft targeting of dendritic cells

PLoS pathogens, 2007-02, Vol.3 (2), p.e25

2007

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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”?

Vaccine, 2015-04, Vol.33 (15), p.1757-1766

2015

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

Biologicals, 2016-03, Vol.44 (2), p.90-110

2016

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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

Biologicals, 2011-11, Vol.39 (6), p.359-369

2011

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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

Toxicological sciences, 2006-06, Vol.91 (2), p.610-619

2006

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

Biologicals, 2016-01, Vol.44 (1), p.37-50

2016

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Mode of action of adjuvants: Implications for vaccine safety and design

Biologicals, 2010-09, Vol.38 (5), p.594-601

2010

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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

Toxicological sciences, 2006-06, Vol.91 (2), p.620-630

2006

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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

Journal of immunotoxicology, 2008-07, Vol.5 (3), p.315-335

2008

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

Journal of acquired immune deficiency syndromes (1999), 2008-01, Vol.47 (1), p.86-92

2008

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Adventitious agents in viral vaccines: Lessons learned from 4 case studies

Biologicals, 2014-09, Vol.42 (5), p.223-236

2014

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A West Nile Virus DNA Vaccine Utilizing a Modified Promoter Induces Neutralizing Antibody in Younger and Older Healthy Adults in a Phase I Clinical Trial

The Journal of infectious diseases, 2011-05, Vol.203 (10), p.1396-1404

2011

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Safety and Immunogenicity of DNA Vaccines Encoding Ebolavirus and Marburgvirus Wild-Type Glycoproteins in a Phase I Clinical Trial

The Journal of infectious diseases, 2015-02, Vol.211 (4), p.549-557

2015

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WHO consultation on clinical evaluation of vaccines, 17–18 July 2014, WHO Headquarters, Geneva, Switzerland

Vaccine, 2015-04, Vol.33 (17), p.1999-2003

2015

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Live virus vaccines based on a yellow fever vaccine backbone: Standardized template with key considerations for a risk/benefit assessment

Vaccine, 2015-01, Vol.33 (1), p.62-72

2015

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A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

Vaccine, 2008-11, Vol.26 (50), p.6338-6343

2008

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International Biologicals Regulation: Vaccines, Biotechnology Medicines By Rebecca L. Sheets Compilation of Weblinks

Fundamentals of Biologicals Regulation, 2018, p.391-413

Sheets, Rebecca

2018

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How to Obtain Documents From ICH and US

Fundamentals of Biologicals Regulation, 2018, p.1-1

Sheets, Rebecca

2018

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Controlled Human Infection Models To Accelerate Vaccine Development

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

Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines

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

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

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

Mechanism of ad5 vaccine immunity and toxicity: fiber shaft targeting of dendritic cells

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

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

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

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

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

Mode of action of adjuvants: Implications for vaccine safety and design

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

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

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

Adventitious agents in viral vaccines: Lessons learned from 4 case studies

A West Nile Virus DNA Vaccine Utilizing a Modified Promoter Induces Neutralizing Antibody in Younger and Older Healthy Adults in a Phase I Clinical Trial

Safety and Immunogenicity of DNA Vaccines Encoding Ebolavirus and Marburgvirus Wild-Type Glycoproteins in a Phase I Clinical Trial

WHO consultation on clinical evaluation of vaccines, 17–18 July 2014, WHO Headquarters, Geneva, Switzerland

Live virus vaccines based on a yellow fever vaccine backbone: Standardized template with key considerations for a risk/benefit assessment

Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial

A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial

International Biologicals Regulation: Vaccines, Biotechnology Medicines By Rebecca L. Sheets Compilation of Weblinks

How to Obtain Documents From ICH and US

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