Literature DB >> 19941989

FDA guidance on prophylactic DNA vaccines: analysis and recommendations.

Dennis M Klinman1, Sven Klaschik, Debra Tross, Hidekazu Shirota, Folkert Steinhagen.   

Abstract

The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this field. (c) 2009 Elsevier Ltd. All rights reserved.

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Year:  2009        PMID： 19941989      PMCID： PMC2847045          DOI： 10.1016/j.vaccine.2009.11.025

Source DB:  PubMed          Journal:  Vaccine        ISSN： 0264-410X            Impact factor:   3.641


  48 in total

1.  Phase 1 safety and immune response studies of a DNA vaccine encoding hepatitis B surface antigen delivered by a gene delivery device.

Authors:  C O Tacket; M J Roy; G Widera; W F Swain; S Broome; R Edelman
Journal:  Vaccine       Date:  1999-07-16       Impact factor: 3.641

2.  Studies on antibody responses following neonatal immunization with influenza hemagglutinin DNA or protein.

Authors:  T M Pertmer; H L Robinson
Journal:  Virology       Date:  1999-05-10       Impact factor: 3.616

Review 3.  DNA vaccines: safety and efficacy issues.

Authors:  D M Klinman; M Takeno; M Ichino; M Gu; G Yamshchikov; G Mor; J Conover
Journal:  Springer Semin Immunopathol       Date:  1997

4.  Contribution of CpG motifs to the immunogenicity of DNA vaccines.

Authors:  D M Klinman; G Yamshchikov; Y Ishigatsubo
Journal:  J Immunol       Date:  1997-04-15       Impact factor: 5.422

5.  Plasmid DNA malaria vaccine: the potential for genomic integration after intramuscular injection.

Authors:  T Martin; S E Parker; R Hedstrom; T Le; S L Hoffman; J Norman; P Hobart; D Lew
Journal:  Hum Gene Ther       Date:  1999-03-20       Impact factor: 5.695

6.  Plasmid DNA malaria vaccine: tissue distribution and safety studies in mice and rabbits.

Authors:  S E Parker; F Borellini; M L Wenk; P Hobart; S L Hoffman; R Hedstrom; T Le; J A Norman
Journal:  Hum Gene Ther       Date:  1999-03-20       Impact factor: 5.695

7.  Enhanced protection against influenza virus of mice immunized as newborns with a mixture of plasmids expressing hemagglutinin and nucleoprotein.

Authors:  A Bot; S Bot; C Bona
Journal:  Vaccine       Date:  1998-10       Impact factor: 3.641

8.  Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine.

Authors:  R Wang; D L Doolan; T P Le; R C Hedstrom; K M Coonan; Y Charoenvit; T R Jones; P Hobart; M Margalith; J Ng; W R Weiss; M Sedegah; C de Taisne; J A Norman; S L Hoffman
Journal:  Science       Date:  1998-10-16       Impact factor: 47.728

9.  Cellular cytotoxic response induced by DNA vaccination in HIV-1-infected patients.

Authors:  S Calarota; G Bratt; S Nordlund; J Hinkula; A C Leandersson; E Sandström; B Wahren
Journal:  Lancet       Date:  1998-05-02       Impact factor: 79.321

10.  First human trial of a DNA-based vaccine for treatment of human immunodeficiency virus type 1 infection: safety and host response.

Authors:  R R MacGregor; J D Boyer; K E Ugen; K E Lacy; S J Gluckman; M L Bagarazzi; M A Chattergoon; Y Baine; T J Higgins; R B Ciccarelli; L R Coney; R S Ginsberg; D B Weiner
Journal:  J Infect Dis       Date:  1998-07       Impact factor: 5.226
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  20 in total

Review 1.  Technologies for enhanced efficacy of DNA vaccines.

Authors:  Fadi Saade; Nikolai Petrovsky
Journal:  Expert Rev Vaccines       Date:  2012-02       Impact factor: 5.217

2.  Vaccine strategies against cystic fibrosis pathogens.

Authors:  Vincent Le Moigne; Jean-Louis Gaillard; Jean-Louis Herrmann
Journal:  Hum Vaccin Immunother       Date:  2016-03-03       Impact factor: 3.452

Review 3.  DNA vaccines: roles against diseases.

Authors:  Kishwar Hayat Khan
Journal:  Germs       Date:  2013-03-01

4.  Pre-clinical toxicity & immunobiological evaluation of DNA rabies vaccine & combination rabies vaccine in rhesus monkeys (Macaca mulatta).

Authors:  B Dinesh Kumar; P Uday Kumar; T Prasanna Krishna; S Kalyanasundaram; P Suresh; V Jagadeesan; S Hariharan; A Nadamuni Naidu; Kamala Krishnaswamy; P N Rangarajan; V A Srinivasan; G S Reddy; B Sesikeran
Journal:  Indian J Med Res       Date:  2013-06       Impact factor: 2.375

5.  Designation of a novel DKK1 multiepitope DNA vaccine and inhibition of bone loss in collagen-induced arthritic mice.

Authors:  Xiaoqing Zhang; Sibo Liu; Shentao Li; Yuxuan Du; Yunpeng Dou; Zhanguo Li; Huihui Yuan; Wenming Zhao
Journal:  Biomed Res Int       Date:  2015-05-05       Impact factor: 3.411

6.  Protective effect of DNA vaccine encoding pseudomonas exotoxin A and PcrV against acute pulmonary P. aeruginosa Infection.

Authors:  Mingzi Jiang; Jing Yao; Ganzhu Feng
Journal:  PLoS One       Date:  2014-05-01       Impact factor: 3.752

7.  Pilot study of p62 DNA vaccine in dogs with mammary tumors.

Authors:  Vladimir Gabai; Franco M Venanzi; Elena Bagashova; Oksana Rud; Francesca Mariotti; Cecilia Vullo; Giuseppe Catone; Michael Y Sherman; Antonio Concetti; Andrey Chursov; Anastasia Latanova; Vita Shcherbinina; Victor Shifrin; Alexander Shneider
Journal:  Oncotarget       Date:  2014-12-30

8.  Development of new plasmid DNA vaccine vectors with R1-based replicons.

Authors:  Diana M Bower; Kristala L J Prather
Journal:  Microb Cell Fact       Date:  2012-08-13       Impact factor: 5.328

9.  Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

Authors:  Yoshikazu Nakayama; Atsushi Aruga
Journal:  Vaccines (Basel)       Date:  2015-03-18

10.  Comparative analysis of enzymatically produced novel linear DNA constructs with plasmids for use as DNA vaccines.

Authors:  A A Walters; E Kinnear; R J Shattock; J U McDonald; L J Caproni; N Porter; J S Tregoning
Journal:  Gene Ther       Date:  2014-05-15       Impact factor: 5.250
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