You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH(n=74): adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injectionSubcutaneous injection in the upper arm with 0.5ml of saline(n=37): saline solution (0.5ml) on Day 0 and Day 21Subcutaneous injection in the upper arm with 0.5ml of saline(n=37): Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21Subcutaneous injection in the upper arm with 0.5ml of salineSubcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injectionComparison of the TH1 cytokine response in the treatment arms compared to placebo from baseline to day 42 following vaccination, calculated as the median fold increase in the number of CD4+ and CD8+ T cells positive for IFN-gamma, TNF-alpha, IL-2 and CD107a.Comparison of the Th1 cytokine response in the treatment arms compared to placebo from baseline to day 180 following vaccination.To compare the number of subjects that showed at least a two-fold increase on day 42 and day 180 following vaccination in the number of CD4+and CD8+ T-cells secreting TH1 cytokines in all groups.To compare the number of subjects identified as responders for cytokine markers as determined by MIMOSA analysis (Responders based on a false discovery rate derived P-value <0.05).Median fold increase in IFN-gamma secretion from PBMCs stimulated in vitro with the FLU-v antigen.
The FLU-v vaccine is designed to be delivered either as a naturally particulate suspension (i.e.
Most common local reactions are local pain, tenderness, erythema and granuloma at the injection site. Please turn on JavaScript and try again.It looks like your browser does not have JavaScript enabled. Browse a complete list of content groups
Blood samples will be taken from all subjects on day 0 (before FLU-v vaccination), 42 (21 days after the second dosing) and 180 (159 days after the second dosing) for the evaluation of FLU-v-specific cellular and humoral immune responses.
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The peak score was the highest daily score during the influenza episode.
Clinical symptom scores to ascertain severity and the incidence of RT-PCR-confirmed influenza A and/or B infection will be recorded during the subsequent influenza season (December 2016 to March 2017) to decide clinical efficacy of the tested vaccines.Study population: Healthy volunteers aged 18-60 years.
Frequency of vaccination is often between 2 and 4 weeks, and the number of injections can reach up to 40.
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Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (azathioprine (Imuran), cyclosporine (Neoral, Sandimmune, SangCya); monoclonal antibodies such as basiliximab (Simulect), daclizumab (Zinbryta), infliximab (Remicade), rituximab …
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The use of live attenuated vaccines should be avoided during treatment with mycophenolic acid delayed-release tablets; examples include (but not limited to) the following: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.
The study follows a factorial design where the two factors are treatment (FLU-v / placebo) and formulation (unadjuvanted / suspension, adjuvanted / emulsion). If the results were positive for influenza then the symptoms were included in the analysis. Please turn on JavaScript and try again.It looks like your browser does not have JavaScript enabled.
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no adjuvant) or emulsified in adjuvant.