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Template protocol for clinical trials investigating vaccines—Focus on safety elements☆
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  1. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)*
    Personal Author:
    Chen, Robert T.; Carbery, Baevin; Mac, Lisa; Chapman, Louisa E.; Condit, Richard C.; Excler, Jean-Louis; Gurwith, Marc; Hendry, Michael; Khan, Arifa S.; Khuri-Bulos, Najwa; Klug, Bettina; Robertson, Jim S.; Seligman, Stephen J.; Sheets, Rebecca; Williamson, Anna-Lise;
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    Recombinant viral vectors provide an effective means for heterologous antigen expression in vivo and thus represent promising platforms for developing novel vaccines against human pathogens from Ebola to tuberculosis. An increasing number of candidat...
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  3. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women
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    Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.;
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    Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inab...
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  4. Live Virus Vaccines Based on a Vesicular Stomatitis Virus (VSV) Backbone: Standardized Template with Key Considerations for a Risk/Benefit Assessment*
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    Clarke, David K.; Hendry, R. Michael; Singh, Vidisha; Rose, John K.; Seligman, Stephen J.; Klug, Bettina; Kochhar, Sonali; Mac, Lisa Marie; Carbery, Baevin; Chen, Robert T;
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    For the Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
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    Jul 06 2016
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    Vaccine. 34(51):6597-6609.
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    The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viral and other microbial pathogens in their genome (so-called "...
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  5. DBD bulletin ; issue 15, fall 2014
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    National Center for Immunization and Respiratory Diseases (U.S.). Division of Bacterial Diseases.
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