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10.1056/NEJMoa1502924 http://scihub22266oqcxt.onion/10.1056/NEJMoa1502924 C5490784!5490784!25830326     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=25830326&cmd=llinks): Failed to open stream: HTTP request failed! HTTP/1.1 429 Too Many Requests in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 215 Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       N+Engl+J+Med 2016 ; 374 (17): 1647-60 Nephropedia Template TP {{tp|p=25830326|t=2016. Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe |pdf=|usr=}}{{25830326}} gab.com Text Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe JO: N Engl J Med http://www.kidney.de/pget.php?&tw=1&pmid=25830326 #FOAvip Background: The replication-competent recombinant vesicular stomatitis virus (rVSV)?based vaccine expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity testing before its use in West Africa. Methods: We performed three open-label, dose-escalation phase 1 trials and one randomized, double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and Africa. All participants were injected with doses of vaccine ranging from 300,000 to 50 million plaque-forming units (PFU) or placebo. Results: No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset reactogenicity was frequent but transient (median, 1 day). Fever was observed in up to 30% of vaccinees. Vaccine viremia was detected within 3 days in 123 of the 130 participants (95%) receiving 3 million PFU or more; rVSV was not detected in saliva or urine. In the second week after injection, arthritis affecting one to four joints developed in 11 of 51 participants (22%) in Geneva, with pain lasting a median of 8 days (interquartile range, 4 to 87); 2 self-limited cases occurred in 60 participants (3%) in Hamburg, Germany, and Kilifi, Kenya. The virus was identified in one synovial-fluid aspirate and in skin vesicles of 2 other vaccinees, showing peripheral viral replication in the second week after immunization. ZEBOV-glycoprotein?specific antibody responses were detected in all the participants, with similar glycoprotein-binding antibody titers but significantly higher neutralizing antibody titers at higher doses. Glycoprotein-binding antibody titers were sustained through 180 days in all participants. Conclusions: In these studies, rVSV-ZEBOV was reactogenic but immunogenic after a single dose and warrants further evaluation for safety and efficacy. (Funded by the Wellcome Trust and others; ClinicalTrials.gov numbers, NCT02283099, NCT02287480, and NCT02296983; Pan African Clinical Trials Registry number, PACTR201411000919191.) Twit Text FOAVip Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe ????N Engl J Med http://www.kidney.de/pget.php?&tw=1&pmid=25830326 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25830326 #FOAvip English Wikipedia <ref>{{Cite pmid|25830326}}</ref> Phase 1 Trials of rVSV Ebola Vaccine in Africa and Europe #MMPMID25830326 Agnandji S; Huttner A; Zinser M; Njuguna P; Dahlke C; Fernandes J; Yerly S; Dayer JA; Kraehling V; Kasonta R; Adegnika A; Altfeld M; Auderset F; Bache E; Biedenkopf N; Borregaard S; Brosnahan J; Burrow R; Combescure C; Desmeules J; Eickmann M; Fehling S; Finckh A; Goncalves A; Grobusch M; Hooper J; Jambrecina A; Kabwende A; Kaya G; Kimani D; Lell B; Lemaître B; Lohse A; Massinga-Loembe M; Matthey A; Mordmüller B; Nolting A; Ogwang C; Ramharter M; Schmidt-Chanasit J; Schmiedel S; Silvera P; Stahl F; Staines H; Strecker T; Stubbe H; Tsofa B; Zaki S; Fast P; Moorthy V; Kaiser L; Krishna S; Becker S; Kieny MP; Bejon P; Kremsner P; Addo M; Siegrist CA N Engl J Med 2016[Apr]; 374 (17): 1647-60 PMID25830326show ga Background: The replication-competent recombinant vesicular stomatitis virus (rVSV)?based vaccine expressing a Zaire ebolavirus (ZEBOV) glycoprotein was selected for rapid safety and immunogenicity testing before its use in West Africa. Methods: We performed three open-label, dose-escalation phase 1 trials and one randomized, double-blind, controlled phase 1 trial to assess the safety, side-effect profile, and immunogenicity of rVSV-ZEBOV at various doses in 158 healthy adults in Europe and Africa. All participants were injected with doses of vaccine ranging from 300,000 to 50 million plaque-forming units (PFU) or placebo. Results: No serious vaccine-related adverse events were reported. Mild-to-moderate early-onset reactogenicity was frequent but transient (median, 1 day). Fever was observed in up to 30% of vaccinees. Vaccine viremia was detected within 3 days in 123 of the 130 participants (95%) receiving 3 million PFU or more; rVSV was not detected in saliva or urine. In the second week after injection, arthritis affecting one to four joints developed in 11 of 51 participants (22%) in Geneva, with pain lasting a median of 8 days (interquartile range, 4 to 87); 2 self-limited cases occurred in 60 participants (3%) in Hamburg, Germany, and Kilifi, Kenya. The virus was identified in one synovial-fluid aspirate and in skin vesicles of 2 other vaccinees, showing peripheral viral replication in the second week after immunization. ZEBOV-glycoprotein?specific antibody responses were detected in all the participants, with similar glycoprotein-binding antibody titers but significantly higher neutralizing antibody titers at higher doses. Glycoprotein-binding antibody titers were sustained through 180 days in all participants. Conclusions: In these studies, rVSV-ZEBOV was reactogenic but immunogenic after a single dose and warrants further evaluation for safety and efficacy. (Funded by the Wellcome Trust and others; ClinicalTrials.gov numbers, NCT02283099, NCT02287480, and NCT02296983; Pan African Clinical Trials Registry number, PACTR201411000919191.) äPhase 1 Trials of rVSV Ebola Vaccine in Africa and Europe (epmc).pdf DeepDyve Pubget Overpricing