Safety and Efficacy of Chimeric Yellow Fever-Dengue Virus Tetravalent Vaccine Formulations in Nonhuman Primates

Guirakhoo, Farshad; Пугачев, К. В.; Zhang, Z.; Myers, Gene; Levenbook, Inessa S.; Draper, Ken; Lang, Jean; Ocran, Simeon W.; Mitchell, Fred; Parsons, M. Angela; Brown, Nathan; Brandler, Samantha; Fournier, C.; Barrère, B.; Rizvi, Farrukh S.; Travassos, Ana Gabriela; Nichols, Richard A.; Trent, Dennis W.; Monath, Thomas P.

doi:10.1128/jvi.78.9.4761-4775.2004

Cited by 238 publications

(194 citation statements)

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“…There was no difference between the genomic sequence obtained from the isolate FDA-Hu2002 (P1) and two passages (P2 and P3) when compared to the genomic sequence obtained from RNA extracted from the original plasma sample. These results are in good concordance with the genetic stability data previously published for the chimeric Dengue and Yellow Fever-Dengue vaccine candidates passaged 10-20 times in Vero cells (Guirakhoo et al, 2004;Butrapet et al, 2006). Therefore we assume that WNV isolates generated from human specimens by a few passages in Vero cells represented the original virus, and that the structural region was not changed during a low number of serial passages in Vero cell cultures.…”

Section: Evaluation Of Genetic Stability Of West Nile Virus After Isosupporting

confidence: 79%

Application of a Microarray-Based Assay for the Study of Genetic Diversity of West Nile Virus

Grinev¹,

Zhong²,

Chizhikov³

et al. 2012

Viral Genomes - Molecular Structure, Diversity, Gene Expression Mechanisms and Host-Virus Interactions

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Section: Evaluation Of Genetic Stability Of West Nile Virus After Isosupporting

confidence: 79%

Application of a Microarray-Based Assay for the Study of Genetic Diversity of West Nile Virus

Grinev¹,

Zhong²,

Chizhikov³

et al. 2012

Viral Genomes - Molecular Structure, Diversity, Gene Expression Mechanisms and Host-Virus Interactions

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“…The titer (PRNT 50 ) was calculated from the highest dilution of test serum reducing the mean plaque count (of duplicate wells) by ≥50%, compared to the mean value of a standard normal control serum. 13 A serum is considered to be positive for the presence of neutralizing antibodies when the neutralizing antibody titer thus determined is at least superior or equal to 1:10. For LNI, 10-fold dilutions of YF17 D virus (commercial YF-VAX ® vaccine passaged once in Vero cells) were mixed with heat inactivated test sera.…”

Section: Methodsmentioning

confidence: 99%

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

Guirakhoo

Kitchener²,

Morrison³

et al. 2006

Human Vaccines

186

136

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A randomized double-blind Phase I Trial was conducted to evaluate safety, tolerability, and immunogenicity of a yellow fever (YF)-dengue 2 (DEN2) chimera (ChimeriVax™-DEN2) in comparison to that of YF vaccine (YF-VAX ® ). Forty-two healthy YF naïve adults randomly received a single dose of either ChimeriVax™-DEN2 (high dose, 5 log plaque forming units [PFU] or low dose, 3 log PFU) or YF-VAX ® by the subcutaneous route (SC). To determine the effect of YF preimmunity on the ChimeriVax TM -DEN2 vaccine, 14 subjects previously vaccinated against YF received a high dose of ChimeriVax™-DEN2 as an open-label vaccine. Most adverse events were similar to YF-VAX ® and of mild to moderate intensity, with no serious side-effects. One hundred percent and 92.3% of YF naïve subjects inoculated with 5.0 and 3.0 log 10 PFU of ChimeriVax TM -DEN2, respectively, seroconverted to wt DEN2 (strain 16681); 92% of subjects inoculated with YF-VAX ® seroconverted to YF 17D virus but none of YF naïve subjects inoculated with ChimeriVax-DEN2 seroconverted to YF 17D virus. Low seroconversion rates to heterologous DEN serotypes 1, 3 and 4 were observed in YF naïve subjects inoculated with either ChimeriVax™-DEN2 or YF-VAX ® . In contrast, 100% of YF immune subjects inoculated with ChimeriVax™-DEN2 seroconverted to all 4 DEN serotypes. Surprisingly, levels of neutralizing antibodies to DEN 1, 2 and 3 viruses in YF immune subjects persisted after 1 year. These data demonstrated that (1) the safety and immunogenicity profile of the ChimeriVax™-DEN2 vaccine is consistent with that of YF-VAX ® , and (2) preimmunity to YF virus does not interfere with ChimeriVax TM -DEN2 immunization, but induces a long lasting and cross neutralizing antibody response to all 4 DEN serotypes. The latter observation can have practical implications toward development of a dengue vaccine.

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“…However, a resurgence of yellow fever in South America and Africa as well as increasing travel to areas in which yellow fever is endemic [1,2], have necessitated continuing investigation into understanding the immune response to this vaccine. Additional interest has been generated by its use as a chimera virus vaccine to induce an immune response to other flaviviruses, such as Japanese Encephalitis virus [3], dengue virus [4] and West Nile virus [5].…”

Section: Introductionmentioning

confidence: 99%

Neutralizing antibody response to booster vaccination with the 17d yellow fever vaccine

Hepburn

Kortepeter

Pittman

et al. 2006

Vaccine

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Safety and Efficacy of Chimeric Yellow Fever-Dengue Virus Tetravalent Vaccine Formulations in Nonhuman Primates

Cited by 238 publications

References 50 publications

Application of a Microarray-Based Assay for the Study of Genetic Diversity of West Nile Virus

Application of a Microarray-Based Assay for the Study of Genetic Diversity of West Nile Virus

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

Neutralizing antibody response to booster vaccination with the 17d yellow fever vaccine

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