human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Cholera is endemic in Bangladesh with epidemics occurring each year . The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting . We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and h and washing to vaccination in this setting . METHODS We did this cluster-r and omised open-label trial in Dhaka , Bangladesh . We r and omly assigned 90 clusters ( 1:1:1 ) to vaccination only , vaccination and behavioural change , or no intervention . The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose . This study is registered with Clinical Trials.gov , number NCT01339845 . FINDINGS Of 268,896 people present at baseline , we analysed 267,270 : 94,675 assigned to vaccination only , 92,539 assigned to vaccination and behavioural change , and 80,056 assigned to non-intervention . Vaccine coverage was 65 % in the vaccination only group and 66 % in the vaccination and behavioural change group . Overall protective effectiveness was 37 % ( 95 % CI lower bound 18 % ; p=0·002 ) in the vaccination group and 45 % ( 95 % CI lower bound 24 % ; p=0·001 ) in the vaccination and behavioural change group . We recorded no vaccine-related serious adverse events . INTERPRETATION Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban population s with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such population s. FUNDING Bill & Melinda Gates Foundation BACKGROUND Oral cholera vaccines represent a new effective tool to fight cholera and are licensed as two-dose regimens with 2 - 4 weeks between doses . Evidence from previous studies suggests that a single dose of oral cholera vaccine might provide substantial direct protection against cholera . During a cholera outbreak in May , 2015 , in Juba , South Sudan , the Ministry of Health , Médecins Sans Frontières , and partners engaged in the first field deployment of a single dose of oral cholera vaccine to enhance the outbreak response . We did a vaccine effectiveness study in conjunction with this large public health intervention . METHODS We did a case-cohort study , combining information on the vaccination status and disease outcomes from a r and om cohort recruited from throughout the city of Juba with that from all the cases detected . Eligible cases were those aged 1 year or older on the first day of the vaccination campaign who sought care for diarrhoea at all three cholera treatment centres and seven rehydration posts throughout Juba . Confirmed cases were suspected cases who tested positive to PCR for Vibrio cholerae O1 . We estimated the short-term protection ( direct and indirect ) conferred by one dose of cholera vaccine ( Shanchol , Shantha Biotechnics , Hyderabad , India ) . FINDINGS Between Aug 9 , 2015 , and Sept 29 , 2015 , we enrolled 87 individuals with suspected cholera , and an 898-person cohort from throughout Juba . Of the 87 individuals with suspected cholera , 34 were classified as cholera positive , 52 as cholera negative , and one had indeterminate results . Of the 858 cohort members who completed a follow-up visit , none developed clinical cholera during follow-up . The unadjusted single-dose vaccine effectiveness was 80·2 % ( 95 % CI 61·5 - 100·0 ) and after adjusting for potential confounders was 87·3 % ( 70·2 - 100·0 ) . INTERPRETATION One dose of Shanchol was effective in preventing medically attended cholera in this study . These results support the use of a single-dose strategy in outbreaks in similar epidemiological setting s. FUNDING Médecins Sans Frontières BACKGROUND A single-dose regimen of the current killed oral cholera vaccines that have been prequalified by the World Health Organization would make them more attractive for use against endemic and epidemic cholera . We conducted an efficacy trial of a single dose of the killed oral cholera vaccine Shanchol , which is currently given in a two-dose schedule , in an urban area in which cholera is highly endemic . METHODS Nonpregnant residents of Dhaka , Bangladesh , who were 1 year of age or older were r and omly assigned to receive a single dose of oral cholera vaccine or oral placebo . The primary outcome was vaccine protective efficacy against culture-confirmed cholera occurring 7 to 180 days after dosing . Prespecified secondary outcomes included protective efficacy against severely dehydrating culture-confirmed cholera during the same interval , against cholera and severe cholera occurring 7 to 90 versus 91 to 180 days after dosing , and against cholera and severe cholera according to age at baseline . RESULTS A total of 101 episodes of cholera , 37 associated with severe dehydration , were detected among the 204,700 persons who received one dose of vaccine or placebo .  The vaccine protective efficacy was 40 % ( 95 % confidence interval [ CI ] , 11 to 60 % ; 0.37 cases per 1000 vaccine recipients vs. 0.62 cases per 1000 placebo recipients ) against all cholera episodes , 63 % ( 95 % CI , 24 to 82 % ; 0.10 vs. 0.26 cases per 1000 recipients ) against severely dehydrating cholera episodes , and 63 % ( 95 % CI , -39 to 90 % ) , 56 % ( 95 % CI , 16 to 77 % ) , and 16 % ( 95 % CI , -49 % to 53 % ) against all cholera episodes among persons vaccinated at the age of 5 to 14 years , 15 or more years , and 1 to 4 years , respectively , although the differences according to age were not significant ( P=0.25 ) . Adverse events occurred at similar frequencies in the two groups . CONCLUSIONS A single dose of the oral cholera vaccine was efficacious in older children ( ≥5 years of age ) and in adults in a setting with a high level of cholera endemicity . ( Funded by the Bill and Melinda Gates Foundation and others ; Clinical Trials.gov number , NCT02027207 . ) We assessed the protective efficacy ( PE ) of three doses of B subunit-killed whole cell ( BS-WC ) and killed whole cell-only ( WC ) oral cholera vaccines in a r and omized , double-blind trial among 62,285 children and women residing in rural Bangladesh . After one complete year of surveillance , 110 cases of cholera were detected in the placebo group , 52 in the WC group ( PE , 53 % ; P less than .0001 ) , and 41 in the BS-WC group ( PE , 62 % ; P less than .0001 ) . Protection was greater for BS-WC recipients than for WC recipients only during the initial eight months of observation . Both vaccines conferred equivalent protection against cholera associated with life-threatening dehydration and against less severe cholera . High- grade , sustained protection was observed in persons vaccinated when older than five years ; in younger persons protection was transient . We conclude that BS-WC and WC vaccines confer significant protection against cholera , particularly in persons vaccinated when older than five years Background Killed oral cholera vaccines ( OCVs ) have been licensed for use in developing countries , but protection conferred by licensed OCVs beyond two years of follow-up has not been demonstrated in r and omized , clinical trials . Methods /Principal Findings We conducted a cluster-r and omized , placebo-controlled trial of a two-dose regimen of a low-cost killed whole cell OCV in residents 1 year of age and older living in 3,933 clusters in Kolkata , India . The primary endpoint was culture-proven Vibrio cholerae O1 diarrhea episodes severe enough to require treatment in a health care facility . Of the 66,900 fully dosed individuals ( 31,932 vaccinees and 34,968 placebo recipients ) , 38 vaccinees and 128 placebo-recipients developed cholera during three years of follow-up ( protective efficacy 66 % ; one-sided 95%CI lower bound = 53 % , p<0.001 ) . Vaccine protection during the third year of follow-up was 65 % ( one-sided 95%CI lower bound = 44 % , p<0.001 ) . Significant protection was evident in the second year of follow-up in children vaccinated at ages 1–4 years and in the third year in older age groups . Conclusions / Significance The killed whole-cell OCV conferred significant protection that was evident in the second year of follow-up in young children and was sustained for at least three years in older age groups . Continued follow-up will be important to establish the vaccine 's duration of protection . Trial Registration Clinical Trials.gov NCT00289224 The first oral cholera vaccine ( OCV ) campaign , since its prequalification by the World Health Organization , in response to an ongoing cholera epidemic ( reactive vaccination ) was successfully conducted in a poor urban slum of approximately 70,000 inhabitants in Port-au-Prince , Haiti , in 2012 . Vaccine coverage was 75 % of the target population . This report documents the impact of OCV in reducing the number of culture-confirmed cases of cholera  admitted to the Groupe Haïtien d'Etude du Sarcome de Kaposi et des Infections Opportunistes ( GHESKIO ) cholera treatment center from that community in the 37 months postvaccination ( April 2012-April 30 , 2015 ) . Of 1,788 patients with culture-confirmed cholera , 1,770 ( 99 % ) were either from outside the vaccine area ( 1,400 cases ) or from the vaccinated community who had not received OCV ( 370 cases ) . Of the 388 people from the catchment area who developed culture-confirmed cholera , 370 occurred among the 17,643 people who had not been vaccinated ( 2.1 % ) and the remaining 18 occurred among the 52,357 people ( 0.034 % ) who had been vaccinated ( P < 0.001 ) , for an efficacy that approximates 97.5 % . Despite not being design ed as a r and omized control trial , the very high efficacy is a strong evidence for the effectiveness of OCV as part of an integrated package for the control of cholera in outbreak setting The protective efficacy of an oral inactivated whole cell Vibrio cholerae plus recombinant B subunit cholera vaccine was determined against El Tor cholera among Peruvian children and adults ( 2 - 65 years old ) in a r and omized , double-blind manner . Study subjects received 2 doses of vaccine or placebo 2 weeks apart , followed by a booster dose 10 months later . Surveillance for cholera was performed actively , with 2 visits per week to each household , and passively , at a local hospital . Stool sample s were collected during diarrhea episodes and were cultured for V. cholerae . A total of 17,799 persons received 2 doses of vaccine or placebo , and 14,997 of these persons received the booster dose . After 2 doses ( first surveillance period ) , V. cholerae biotype O1 was isolated from 17 vaccinees and 16 placebo recipients , demonstrating vaccine efficacy ( VE ) of -4 % . After 3 doses ( second surveillance period ) , V. cholerae O1 was isolated from 13 vaccinees and 32 placebo recipients , demonstrating VE of 61 % ( 95 % confidence interval ¿ CI , 28%-79 % ) . In the second surveillance period , the VE for illness requiring hospitalization was 82 % ( 95 % CI , 27%-96 % ) . VE was also higher for persons > 15 years old ( VE , 72 % ; 95 % CI , 28%-89 % ) BACKGROUND Zanzibar , in east Africa , has been severely and repeatedly affected by cholera since 1978 . We assessed the effectiveness of oral cholera vaccination in high-risk population s in the archipelago to estimate the indirect ( herd ) protection conferred by the vaccine and direct vaccine effectiveness . METHODS We offered two doses of a killed whole-cell B-subunit cholera vaccine to individuals aged 2 years and older in six rural and 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND Cholera is endemic in Bangladesh with epidemics occurring each year . The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting . We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and h and washing to vaccination in this setting . METHODS We did this cluster-r and omised open-label trial in Dhaka , Bangladesh . We r and omly assigned 90 clusters ( 1:1:1 ) to vaccination only , vaccination and behavioural change , or no intervention . The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose . This study is registered with Clinical Trials.gov , number NCT01339845 . FINDINGS Of 268,896 people present at baseline , we analysed 267,270 : 94,675 assigned to vaccination only , 92,539 assigned to vaccination and behavioural change , and 80,056 assigned to non-intervention . Vaccine coverage was 65 % in the vaccination only group and 66 % in the vaccination and behavioural change group . Overall protective effectiveness was 37 % ( 95 % CI lower bound 18 % ; p=0·002 ) in the vaccination group and 45 % ( 95 % CI lower bound 24 % ; p=0·001 ) in the vaccination and behavioural change group . We recorded no vaccine-related serious adverse events . INTERPRETATION Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban population s with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such population s. FUNDING Bill & Melinda Gates Foundation BACKGROUND Oral cholera vaccines represent a new effective tool to fight cholera and are licensed as two-dose regimens with 2 - 4 weeks between doses . Evidence from previous studies suggests that a single dose of oral cholera vaccine might provide substantial direct protection against cholera . During a cholera outbreak in May , 2015 , in Juba , South Sudan , the Ministry of Health , Médecins Sans Frontières , and partners engaged in the first field deployment of a single dose of oral cholera vaccine to enhance the outbreak response . We did a vaccine effectiveness study in conjunction with this large public health intervention . METHODS We did a case-cohort study , combining information on the vaccination status and disease outcomes from a r and om cohort recruited from throughout the city of Juba with that from all the cases detected . Eligible cases were those aged 1 year or older on the first day of the vaccination campaign who sought care for diarrhoea at all three cholera treatment centres and seven rehydration posts throughout Juba . Confirmed cases were suspected cases who tested positive to PCR for Vibrio cholerae O1 . We estimated the short-term protection ( direct and indirect ) conferred by one dose of cholera vaccine ( Shanchol , Shantha Biotechnics , Hyderabad , India ) . FINDINGS Between Aug 9 , 2015 , and Sept 29 , 2015 , we enrolled 87 individuals with suspected cholera , and an 898-person cohort from throughout Juba . Of the 87 individuals with suspected cholera , 34 were classified as cholera positive , 52 as cholera negative , and one had indeterminate results . Of the 858 cohort members who completed a follow-up visit , none developed clinical cholera during follow-up . The unadjusted single-dose vaccine effectiveness was 80·2 % ( 95 % CI 61·5 - 100·0 ) and after adjusting for potential confounders was 87·3 % ( 70·2 - 100·0 ) . INTERPRETATION One dose of Shanchol was effective in preventing medically attended cholera in this study . These results support the use of a single-dose strategy in outbreaks in similar epidemiological setting s. FUNDING Médecins Sans Frontières BACKGROUND A single-dose regimen of the current killed oral cholera vaccines that have been prequalified by the World Health Organization would make them more attractive for use against endemic and epidemic cholera . We conducted an efficacy trial of a single dose of the killed oral cholera vaccine Shanchol , which is currently given in a two-dose schedule , in an urban area in which cholera is highly endemic . METHODS Nonpregnant residents of Dhaka , Bangladesh , who were 1 year of age or older were r and omly assigned to receive a single dose of oral cholera vaccine or oral placebo . The primary outcome was vaccine protective efficacy against culture-confirmed cholera occurring 7 to 180 days after dosing . Prespecified secondary outcomes included protective efficacy against severely dehydrating culture-confirmed cholera during the same interval , against cholera and severe cholera occurring 7 to 90 versus 91 to 180 days after dosing , and against cholera and severe cholera according to age at baseline . RESULTS A total of 101 episodes of cholera , 37 associated with severe dehydration , were detected among the 204,700 persons who received one dose of vaccine or placebo .  The vaccine protective efficacy was 40 % ( 95 % confidence interval [ CI ] , 11 to 60 % ; 0.37 cases per 1000 vaccine recipients vs. 0.62 cases per 1000 placebo recipients ) against all cholera episodes , 63 % ( 95 % CI , 24 to 82 % ; 0.10 vs. 0.26 cases per 1000 recipients ) against severely dehydrating cholera episodes , and 63 % ( 95 % CI , -39 to 90 % ) , 56 % ( 95 % CI , 16 to 77 % ) , and 16 % ( 95 % CI , -49 % to 53 % ) against all cholera episodes among persons vaccinated at the age of 5 to 14 years , 15 or more years , and 1 to 4 years , respectively , although the differences according to age were not significant ( P=0.25 ) . Adverse events occurred at similar frequencies in the two groups . CONCLUSIONS A single dose of the oral cholera vaccine was efficacious in older children ( ≥5 years of age ) and in adults in a setting with a high level of cholera endemicity . ( Funded by the Bill and Melinda Gates Foundation and others ; Clinical Trials.gov number , NCT02027207 . ) We assessed the protective efficacy ( PE ) of three doses of B subunit-killed whole cell ( BS-WC ) and killed whole cell-only ( WC ) oral cholera vaccines in a r and omized , double-blind trial among 62,285 children and women residing in rural Bangladesh . After one complete year of surveillance , 110 cases of cholera were detected in the placebo group , 52 in the WC group ( PE , 53 % ; P less than .0001 ) , and 41 in the BS-WC group ( PE , 62 % ; P less than .0001 ) . Protection was greater for BS-WC recipients than for WC recipients only during the initial eight months of observation . Both vaccines conferred equivalent protection against cholera associated with life-threatening dehydration and against less severe cholera . High- grade , sustained protection was observed in persons vaccinated when older than five years ; in younger persons protection was transient . We conclude that BS-WC and WC vaccines confer significant protection against cholera , particularly in persons vaccinated when older than five years Background Killed oral cholera vaccines ( OCVs ) have been licensed for use in developing countries , but protection conferred by licensed OCVs beyond two years of follow-up has not been demonstrated in r and omized , clinical trials . Methods /Principal Findings We conducted a cluster-r and omized , placebo-controlled trial of a two-dose regimen of a low-cost killed whole cell OCV in residents 1 year of age and older living in 3,933 clusters in Kolkata , India . The primary endpoint was culture-proven Vibrio cholerae O1 diarrhea episodes severe enough to require treatment in a health care facility . Of the 66,900 fully dosed individuals ( 31,932 vaccinees and 34,968 placebo recipients ) , 38 vaccinees and 128 placebo-recipients developed cholera during three years of follow-up ( protective efficacy 66 % ; one-sided 95%CI lower bound = 53 % , p<0.001 ) . Vaccine protection during the third year of follow-up was 65 % ( one-sided 95%CI lower bound = 44 % , p<0.001 ) . Significant protection was evident in the second year of follow-up in children vaccinated at ages 1–4 years and in the third year in older age groups . Conclusions / Significance The killed whole-cell OCV conferred significant protection that was evident in the second year of follow-up in young children and was sustained for at least three years in older age groups . Continued follow-up will be important to establish the vaccine 's duration of protection . Trial Registration Clinical Trials.gov NCT00289224 The first oral cholera vaccine ( OCV ) campaign , since its prequalification by the World Health Organization , in response to an ongoing cholera epidemic ( reactive vaccination ) was successfully conducted in a poor urban slum of approximately 70,000 inhabitants in Port-au-Prince , Haiti , in 2012 . Vaccine coverage was 75 % of the target population . This report documents the impact of OCV in reducing the number of culture-confirmed cases of cholera  admitted to the Groupe Haïtien d'Etude du Sarcome de Kaposi et des Infections Opportunistes ( GHESKIO ) cholera treatment center from that community in the 37 months postvaccination ( April 2012-April 30 , 2015 ) . Of 1,788 patients with culture-confirmed cholera , 1,770 ( 99 % ) were either from outside the vaccine area ( 1,400 cases ) or from the vaccinated community who had not received OCV ( 370 cases ) . Of the 388 people from the catchment area who developed culture-confirmed cholera , 370 occurred among the 17,643 people who had not been vaccinated ( 2.1 % ) and the remaining 18 occurred among the 52,357 people ( 0.034 % ) who had been vaccinated ( P < 0.001 ) , for an efficacy that approximates 97.5 % . Despite not being design ed as a r and omized control trial , the very high efficacy is a strong evidence for the effectiveness of OCV as part of an integrated package for the control of cholera in outbreak setting The protective efficacy of an oral inactivated whole cell Vibrio cholerae plus recombinant B subunit cholera vaccine was determined against El Tor cholera among Peruvian children and adults ( 2 - 65 years old ) in a r and omized , double-blind manner . Study subjects received 2 doses of vaccine or placebo 2 weeks apart , followed by a booster dose 10 months later . Surveillance for cholera was performed actively , with 2 visits per week to each household , and passively , at a local hospital . Stool sample s were collected during diarrhea episodes and were cultured for V. cholerae . A total of 17,799 persons received 2 doses of vaccine or placebo , and 14,997 of these persons received the booster dose . After 2 doses ( first surveillance period ) , V. cholerae biotype O1 was isolated from 17 vaccinees and 16 placebo recipients , demonstrating vaccine efficacy ( VE ) of -4 % . After 3 doses ( second surveillance period ) , V. cholerae O1 was isolated from 13 vaccinees and 32 placebo recipients , demonstrating VE of 61 % ( 95 % confidence interval ¿ CI , 28%-79 % ) . In the second surveillance period , the VE for illness requiring hospitalization was 82 % ( 95 % CI , 27%-96 % ) . VE was also higher for persons > 15 years old ( VE , 72 % ; 95 % CI , 28%-89 % ) BACKGROUND Zanzibar , in east Africa , has been severely and repeatedly affected by cholera since 1978 . We assessed the effectiveness of oral cholera vaccination in high-risk population s in the archipelago to estimate the indirect ( herd ) protection conferred by the vaccine and direct vaccine effectiveness . METHODS We offered two doses of a killed whole-cell B-subunit cholera vaccine to individuals aged 2 years and older in six rural and 
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