 good afternoon it's always difficult for the last because most of you might then you want to be at the pub now have having a nice drink which is very much understandable but i'm going to try to make it abc and rotavirus is a major cause of mortality and morbidity worldwide especially among children under five years which is deep and with a disproportionate effect in sub-Saharan Africa previous studies on rotavirus vaccine in low-income countries have shown variable efficacy but even if the the high prevalence given the high prevalence of the disease in these settings they provide a real public health benefit and there are two world health organization pre-qualified vaccines but both require cold chain and a large storage value on top of this the existing vaccine supply is not sufficient they are also expensive a landscape review of the existing vaccine and vaccine candidates showed that an oral rotavirus recombinant rotavirus vaccine developed by the serum institute of injera limited was very promising at 37 degrees Celsius it is stable for one year and his two data collected in injera showed very good safety and immunogenicity these features make it a good candidate for use in limited resources countries but there was no efficacy safety or immunogenicity data in Africa epicent has been working in on rotavirus in niger for nearly 10 years previous studies aimed to describe health seeking behaviors around diarrhea and showed that rotavirus was responsible for about a third of diarrhea in children seeking for at health care facilities this newspaper headline came after a public consultation in nyame with national authorities and local leaders given the imperfection of existing vaccines there was a broad agreement on the need to find a better adapted vaccine for niger such as brv pv that i just described this the aim of this trial is to assess the efficacy and safety of the brv pv against severe rotavirus deaths and ferrities this randomized phase three trial is conducted in double blind and is placebo controlled it takes place in mother room for a health district and covers all the villages within 15 kilometers in five health centers infants enrolled in the trial received doses of vaccines at six 10 and 14 weeks together with the routine expanded program on immunization antigens the vaccine was shipped in a cold chain but after arrival on sites is stored at ambient temperatures inclusion and exclusion criteria were standard compared to other rotavirus vaccines but there was no restriction related to breastfeeding HIV status or malnutrition the event driven trial was designed to produce results faster while ensuring the same statistical power has other clinical trials event driven means that primary analysis is triggered after 117 cases of severe rotavirus gastroenteritis have occurred this number of cases is based on the assumptions you see listed we estimated with 7,770 children enrolled would be certain to be able to accrue 117 cases but the advantage of this event driven design is that our target is cases of severe rotavirus gastroenteritis not the total number of children enrolled which allows for greater efficiency the definitions used in the trial were standard and gastroenteritis severity was scored using the vesicle scale a validated composite score which runs from 1 to 20 based on several clinical symptoms and need for treatment active surveillance for rotavirus gastroenteritis is conducted in health facilities and at home participants come to health facilities for scheduled study visits and are asked to come at any time for any health problem in particular for diarrhea a weekly home visit from a community health worker is used to follow up on cases of diarrhea and adverse events and to identify any event not yet reported monitoring safety starts at with an observation of 30 minutes at each dose at the vaccination site serious adverse events are monitored until two years of age the study protocol was approved by five ethical review boards and was conducted with international standard and guidelines a data and safety monitoring board regularly reviewed the trial data and an independent adjudication committee was in place to review suspected cases of intersuception approvals and authorizations for the study were obtained in the second quarter of 2014 a pilot study began in June and the first inclusions of the trial in the trial was in august 2014 on 26 november 2015 the 117 cases of severe rotavirus gastroenteritis to trigger the primary efficacy analysis had occurred at this point 4,091 infants had been enrolled then the 30 database was locked and the results I present here come from this primary database follow up for secondary hand points and safety is continuing characteristics of the children in the vaccine and placebo group was similar at baseline the results of the primary analysis were published in March the incidence of severe rotavirus gastroenteritis was significantly higher in children received placebo this difference translates into a vaccine efficacy of 66.7 percent against severe rotavirus gastroenteritis our primary outcome importantly for real-life context vaccine efficacy in the intention to treat population and also against very severe rotavirus gastroenteritis was similar to the per protocol population about vaccine safety the risk of serious adverse events was not increased in children who received the vaccine in particular there was no increased risk of death or hospitalization associated with the vaccine no case of intersuception was confirmed in either of the two groups out of this interesting experience the fact of the matter is that three doses of BRV PV an oral rotavirus vaccine had an efficacy of 66.7 percent against severe rotavirus gastroenteritis among infants in Niger we did not identify any safety concerned with BRV PV the confirmed heat stability of this vaccine provides advantages for vaccine delivery in remote areas where cold chain capacity is limited this study conducted with an HR pool exclusively from the Sahil region gives an example of how to run clinical research in difficult contexts has for the next steps we will perform analysis on the long-term efficacy of the vaccine and continue following safety indicators through two years of age we are still awaiting the results regarding the immunological response in a subgroup of children and its genotype specific efficacy as well secondary analysis will also explore the possibility of reducing dosing the vaccine was licensed last December in India under the trade name Rotasil and licensure in Niger and World Health Organization pre-qualification process are ongoing this study couldn't have been conducted without the support of Nersensan Frontiers Switzerland it will never be possible to think all who have helped make this trial a success but many are listed on this slide of course I must give very special thanks to the participating children and their parents thank you for your attention thank you very much excellent talk and I think this is really a major triumph for MSF Episod as an outsider I think I can say this there's now a new vaccine and it has it is superior in some ways to the to the old vaccines and the competition is not so enthusiastic about having a new competitor in the field any technical questions there's one in the back here thanks I'm very nice talk was there did you look at the genotype of the of the patients involved the genotyping of of the rotavirus was it done sorry was the genotyping of the virus done at during the the trial all this the analysis are ongoing you don't have the specific genotypes yet but it will be a generous contribution from Africa towards the scientific world globally but we're still waiting for these results thank you okay there's one more hi I'm Ann Marie again from MSF and so as I'm just wondering this vaccine was obviously tested on confirmed rotavirus infection has there been any further analysis whether or not the introduction of the vaccine has overall reduced hospitalizations for acute diarrhea as well we know that it's effective for rotavirus probably now there are other viruses that cause diarrhea and if there's been a population wide impact on reducing overall hospitalization for severe dehydration associated with diarrhea well we have we have shown an efficacy of 66.7 percent for on severe cases and also the the results on very severe cases was similar but if you consider all the all the rotavirus infections the efficacy is lower because this vaccine is considering the the five most infectious strains of the of the virus I don't know if I