WHO Working Group on technical specifications for manufacture and evaluation of dengue vaccines, Geneva, Switzerland, 11–12 May 2009
Tài liệu tham khảo
Vaughn, 2009, Dengue, 287
Halstead, 2008, Dengue vaccines, 115
Whitehead, 2007, Prospects for a dengue virus vaccine, Nat Rev Microbiol, 5, 518, 10.1038/nrmicro1690
Hombach, 2007, Vaccines against dengue: a review of current candidate vaccines at advanced development stages, Rev Panam Salud Publica, 21, 254, 10.1590/S1020-49892007000300011
Blaney, 2008, Dengue virus type 3 vaccine candidates generated by introduction of deletions in the 3′ untranslated region (3′-UTR) or by exchange of the DENV-3 3′-UTR with that of DENV-4, Vaccine, 26, 817, 10.1016/j.vaccine.2007.11.082
World Health Organization. Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). In: WHO Expert Committee on Biological Standardization. Fifty-fifth report. Geneva, World Health Organization; 2006, Annex 1 (WHO Technical Report Series No. 932) [http://www.who.int/biologicals/publications/trs/areas/vaccines/dengue/TRS932Annex%201_Dengue%20virus%20vacc%20live.pdf].
World Health Organization. Requirements for hepatitis B vaccines made by recombinant DNA techniques (requirements for biological substances no. 45). In: WHO Expert Committee on Biological Standardization. Thirty-ninth report. Geneva, World Health Organization; 1989, Annex 2 WHO Technical Report Series, No. [http://www.who.int/entity/biologicals/publications/trs/areas/vaccines/hepatitis/WHO_TRS_786_A2.pdf].
World Health Organization. Requirements for hepatitis B vaccines made by recombinant DNA techniques (requirements for biological substances no. 45, amendment 1997). In: WHO Expert Committee on Biological Standardization. Forty-eighth report. Geneva, World Health Organization, 1999, Annex 4 (WHO Technical Report Series, No. 889) [http://www.who.int/biologicals/publications/trs/areas/vaccines/hepatitis/WHO_TRS_889_A4.pdf].
World Health Organization. Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines. In: WHO Expert Committee on Biological Standardization. Geneva, World Health Organization, (Adopted 2006), in press [http://www.who.int/biologicals/publications/trs/areas/vaccines/human_papillomavirus/HPVg%20Final%20BS%202050%20.pdf].
World Health Organization. Guidelines for assuring the quality and non-clinical safety evaluation of DNA vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization; 2007, Annex 1 (WHO Technical Report Series No. 941) [http://www.who.int/biologicals/publications/trs/areas/vaccines/dna/Annex%201_DNA%20vaccines.pdf].
World Health Organization. Requirements for the use of animal cells as in vitro substrates for the production of biologicals (requirements for biological substances no. 50). In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization; 1998, Annex 1 (WHO Technical Report Series, No. 878) [http://www.who.int/biologicals/publications/trs/areas/vaccines/cells/WHO_TRS_878_A1Animalcells.pdf].
World Health Organization. Requirements for the use of animal cells as in vitro substrates for the production of biologicals (addendum 2003). In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization, 2005, Annex 4 (WHO Technical Report Series, No. 927) [http://www.who.int/biologicals/publications/amendment_cell_substrates_ecbs_nov_2003.pdf].
U.S. Food and Drug Administration. Guidance for Industry: Characterization and qualification of cell substrates and other biological starting materials used for the production of viral vaccines for the prevention and treatment of infectious diseases; 2010 [http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf].
Petricciani, 2008, An overview of animal cell substrates for biological products, Biologicals, 36, 359, 10.1016/j.biologicals.2008.06.004
Sheng-Fowler, 2009, Issues associated with residual cell-substrate DNA in viral vaccines, Biologicals, 37, 190, 10.1016/j.biologicals.2009.02.015
Knezevic, 2008, WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11–12 June 2007, Biologicals, 36, 203, 10.1016/j.biologicals.2007.11.005
Baylor, 2008, Regulation and testing of vaccines, 1611
Krause, 2009, Regulatory issues related to vaccines against emerging infectious diseases, 191
Novak, 2009, The pre-IND/IND regulatory process: vaccines, 172
Monath, 2005, Safety testing for neurovirulence of novel live, attenuated flavivirus vaccines: infant mice provide an accurate surrogate for the test in monkeys, Biologicals, 33, 131, 10.1016/j.biologicals.2005.03.009
Guirakhoo, 2006, Live attenuated chimeric yellow fever dengue type 2 (ChimeriVax-DEN2) vaccine: Phase I clinical trial for safety and immunogenicity: effect of yellow fever pre-immunity in induction of cross neutralizing antibody responses to all 4 dengue serotypes, Hum Vaccine, 2, 60, 10.4161/hv.2.2.2555
Ishikawa, 2008, Construction and evaluation of a chimeric pseudoinfectious virus vaccine to prevent Japanese encephalitis, Vaccine, 26, 2772, 10.1016/j.vaccine.2008.03.010
Guy, 2008, Safety of flavivirus chimeric vaccines: answer to Ishikawa et al [Vaccine 26 (22) (2008) 2772–2781], Vaccine, 26, 4107, 10.1016/j.vaccine.2008.05.056
Guy, 2009, Evaluation of interferences between dengue vaccine serotypes in a monkey model, Am J Trop Med Hyg, 80, 302, 10.4269/ajtmh.2009.80.302
World Health Organization. IVB/08.12. Guidelines for the clinical evaluation of dengue vaccines in endemic areas. Geneva: World Health Organization; 2008.
Edelman, 2008, “Guidelines for the clinical evaluation of dengue vaccines in endemic areas”: summary of a World Health Organization technical consultation, Vaccine, 26, 4113, 10.1016/j.vaccine.2008.05.058
World Health Organization. WHO guidelines on clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization. Fifty-second report. Geneva, World Health Organization; 2004, Annex 1 (WHO Technical Report Series, No. 924) [http://www.who.int/biologicals/publications/trs/areas/vaccines/clinical_evaluation/035-101.pdf].
World Health Organization. WHO guidelines on nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth report. Geneva, World Health Organization; 2005, Annex 1 (WHO Technical Report Series, No. 927) [http://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf].
Roehrig, 2008, Guidelines for plaque-reduction neutralization testing of human antibodies to dengue viruses, Viral Immunol, 21, 123, 10.1089/vim.2008.0007