scholarly journals Author response: Genetic epidemiology of dengue viruses in phase III trials of the CYD tetravalent dengue vaccine and implications for efficacy

2017 ◽  
Author(s):  
Maia A Rabaa ◽  
Yves Girerd-Chambaz ◽  
Kien Duong Thi Hue ◽  
Trung Vu Tuan ◽  
Bridget Wills ◽  
...  
Keyword(s):  
Genetic Epidemiology ◽  
Phase Iii ◽  
Author Response ◽  
Dengue Vaccine ◽  
Dengue Viruses ◽  
Phase Iii Trials

scholarly journals Genetic epidemiology of dengue viruses in phase III trials of the CYD tetravalent dengue vaccine and implications for efficacy

eLife ◽  
2017 ◽  
Vol 6 ◽  
Author(s):  
Maia A Rabaa ◽  
Yves Girerd-Chambaz ◽  
Kien Duong Thi Hue ◽  
Trung Vu Tuan ◽  
Bridget Wills ◽  
...  
Keyword(s):  
Genetic Epidemiology ◽  
Phase Iii ◽  
Envelope Gene ◽  
Dengue Vaccine ◽  
Virus Genotype ◽  
Pivotal Phase ◽  
Dengue Viruses ◽  
High Amino Acid ◽  
Phase Iii Trials ◽  
Trial Participants

This study defined the genetic epidemiology of dengue viruses (DENV) in two pivotal phase III trials of the tetravalent dengue vaccine, CYD-TDV, and thereby enabled virus genotype-specific estimates of vaccine efficacy (VE). Envelope gene sequences (n = 661) from 11 DENV genotypes in 10 endemic countries provided a contemporaneous global snapshot of DENV population genetics and revealed high amino acid identity between the E genes of vaccine strains and wild-type viruses from trial participants, including at epitope sites targeted by virus neutralising human monoclonal antibodies. Post-hoc analysis of all CYD14/15 trial participants revealed a statistically significant genotype-level VE association within DENV-4, where efficacy was lowest against genotype I. In subgroup analysis of trial participants age 9–16 years, VE estimates appeared more balanced within each serotype, suggesting that genotype-level heterogeneity may be limited in older children. Post-licensure surveillance is needed to monitor vaccine performance against the backdrop of DENV sequence diversity and evolution.

Author response for "Characteristics and Risk Factors of Bortezomib Induced Peripheral Neuropathy: A Systematic Review of Phase III Trials"

2019 ◽  
Author(s):  
Tiffany Li ◽  
Hannah C. Timmins ◽  
Tracy King ◽  
Matthew C. Kiernan ◽  
David Goldstein ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Peripheral Neuropathy ◽  
Phase Iii ◽  
Author Response ◽  
Phase Iii Trials

scholarly journals Potential impact of dengue vaccination: Insights from two large-scale phase III trials with a tetravalent dengue vaccine

Vaccine ◽  
2016 ◽  
Vol 34 (50) ◽  
pp. 6426-6435 ◽  
Author(s):  
Laurent Coudeville ◽  
Nicolas Baurin ◽  
Maïna L’Azou ◽  
Bruno Guy
Keyword(s):  
Large Scale ◽  
Phase Iii ◽  
Dengue Vaccine ◽  
Phase Iii Trials ◽  
Potential Impact

Clinical implications and outcomes of the ORION Phase III trials

2020 ◽  
Author(s):  
Julia Brandts ◽  
Kausik K Ray
Keyword(s):  
Familial Hypercholesterolemia ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Phase Iii ◽  
Atherosclerotic Cardiovascular Disease ◽  
Low Density Lipoprotein Cholesterol ◽  
Clinical Safety ◽  
Phase Iii Trials ◽  
Phase Ii And Iii ◽  
Ongoing Phase

Inclisiran is a siRNA inhibiting hepatic PCSK9 synthesis. As a first-in-class therapy, inclisiran has been assessed within the ORION trial program for its low-density lipoprotein cholesterol (LDL-C) lowering efficacy and clinical safety. Phase II and III trials have shown that inclisiran lowers LDL-C by about 50% with an infrequent dosing schedule in patients with established atherosclerotic cardiovascular disease and those at high risk, including patients with heterozygous familial hypercholesterolemia. Ongoing Phase III trials will provide evidence on longer-term safety and effectiveness, and inclisiran’s efficacy in patients with homozygous familial hypercholesterolemia. Furthermore, the ORION-4 trial will assess inclisiran’s impact on cardiovascular outcomes.

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