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: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Summary Background BCG vaccination provides incomplete protection against tuberculosis in infants . A new vaccine , modified Vaccinia Ankara virus expressing antigen 85A ( MVA85A ) , was design ed to enhance the protective efficacy of BCG . We aim ed to assess safety , immunogenicity , and efficacy of MVA85A against tuberculosis and Mycobacterium tuberculosis infection in infants . Methods In our double-blind , r and omised , placebo-controlled phase 2b trial , we enrolled healthy infants ( aged 4–6 months ) without HIV infection who had previously received BCG vaccination . We r and omly allocated infants ( 1:1 ) , according to an independently generated sequence with block sizes of four , to receive one intradermal dose of MVA85A or an equal volume of C and ida skin test antigen as placebo at a clinical facility in a rural region near Cape Town , South Africa . We actively followed up infants every 3 months for up to 37 months . The primary study outcome was safety ( incidence of adverse and serious adverse events ) in all vaccinated participants , but we also assessed efficacy in a protocol -defined group of participants who received at least one dose of allocated vaccine . The primary efficacy endpoint was incident tuberculosis incorporating microbiological , radiological , and clinical criteria , and the secondary efficacy endpoint was M tuberculosis infection according to QuantiFERON TB Gold In-tube conversion ( Cellestis , Australia ) . This trial was registered with the South African National Clinical Trials Register ( DOH-27 - 0109 - 2654 ) and with Clinical Trials.gov on July 31 , 2009 , number NCT00953927 Findings Between July 15 , 2009 , and May 4 , 2011 , we enrolled 2797 infants ( 1399 allocated MVA85A and 1398 allocated placebo  ) . Median follow-up in the per- protocol population was 24·6 months ( IQR 19·2–28·1 ) , and did not differ between groups . More infants who received MVA85A than controls had at least one local adverse event ( 1251 [ 89 % ] of 1399 MVA85A recipients and 628 [ 45 % ] of 1396 controls who received the allocated intervention ) but the numbers of infants with systemic adverse events ( 1120 [ 80 % ] and 1059 [ 76 % ] ) or serious adverse events ( 257 [ 18 % ] and 258 ( 18 % ) did not differ between groups . None of the 648 serious adverse events in these 515 infants was related to MVA85A . 32 ( 2 % ) of 1399 MVA85A recipients met the primary efficacy endpoint ( tuberculosis incidence of 1·15 per 100 person-years [ 95 % CI 0·79 to 1·62 ] ; with conversion in 178 [ 13 % ] of 1398 infants [ 95 % CI 11·0 to 14·6 ] ) as did 39 ( 3 % ) of 1395 controls ( 1·39 per 100 person-years [ 1·00 to 1·91 ] ; with conversion in 171 [ 12 % ] of 1394 infants [ 10·6 to 14·1 ] ) . Efficacy against tuberculosis was 17·3 % ( 95 % CI −31·9 to 48·2 ) and against M tuberculosis infection was −3·8 % ( –28·1 to 15·9 ) . Interpretation MVA85A was well tolerated and induced modest cell-mediated immune responses . Reasons for the absence  of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants need exploration . Funding Aeras , Wellcome Trust , and Oxford-Emergent Tuberculosis Consortium ( OETC ) The Medical Research Council 's trial of BCG and vole bacillus vaccines in the prevention of  tuberculosis in Great Britain has ended after 20 years ' follow-up of the 54 239 participants , who were aged 14 to 15 years when the entered the trial in 1950 - 2 . Participants who were tuberculin positive on entry were left unvaccinated ; those who were tuberculin negative were allocated at r and om to an unvaccinated or to a vaccinated group . The protective efficacy of each of the two vaccines , among those initially tuberculin negative , was 84 % during the first five years , and gradually decreased , averaging 77 % for each vaccine over the whole period . The incidence of tuberculosis decreased substantially in all groups during the trial , however , and of the total of 610 cases of tuberculosis only 27 developed between 15 and 20 years . Thus we can not make a reliable assessment of efficacy during this final period . The prevalence and incidence of tuberculosis in Great Britain have decreased radically since this trial began . The expected benefit from large-scale BCG-vaccination of children is now far less , and may decrease further if the incidence of tuberculosis continues to decline A clinical trial of B.C.G. and vole bacillus vaccines , directed by the Tuberculosis Vaccines Clinical Trials Committee of the Medical Research Council ( M.R.C. ) , was begun in Engl and in 1950 , and is still in progress . The effect of the vaccines is being studied during adolescence and early adult life in groups with no special risk of exposure to tuberculous infection , and initially free both from active tuberculosis and from known contact with the disease at home . There are more than 50,000 participants of both sexes in the investigation , all aged 14 to 152 years on entry , and now aged between 21 and 23 years . Those with negative reactions to tuberculin on entry were vaccinated with B.C.G. or vole bacillus vaccine or left unvaccinated , according to a method of r and om allocation . All the participants , including those with a positive reaction to tuberculin initially , have now ( January , 1959 ) been followed intensively for more than six years . The first report of this investigation ( M.R.C. , 1956 ; see also Hart , Pollock , and Sutherl and , 1957 ) presented complete results after each participant had been in the trial for two and a half years . The present report gives corresponding results for the period of five years since entry to the trial , together with preliminary incomplete information for the period between five and seven and a half years after entry . The work described was carried out by the Council 's Tuberculosis Research Unit , with the assistance of many statutory and voluntary organizations ( see Acknowledgments ) 
    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: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Summary Background BCG vaccination provides incomplete protection against tuberculosis in infants . A new vaccine , modified Vaccinia Ankara virus expressing antigen 85A ( MVA85A ) , was design ed to enhance the protective efficacy of BCG . We aim ed to assess safety , immunogenicity , and efficacy of MVA85A against tuberculosis and Mycobacterium tuberculosis infection in infants . Methods In our double-blind , r and omised , placebo-controlled phase 2b trial , we enrolled healthy infants ( aged 4–6 months ) without HIV infection who had previously received BCG vaccination . We r and omly allocated infants ( 1:1 ) , according to an independently generated sequence with block sizes of four , to receive one intradermal dose of MVA85A or an equal volume of C and ida skin test antigen as placebo at a clinical facility in a rural region near Cape Town , South Africa . We actively followed up infants every 3 months for up to 37 months . The primary study outcome was safety ( incidence of adverse and serious adverse events ) in all vaccinated participants , but we also assessed efficacy in a protocol -defined group of participants who received at least one dose of allocated vaccine . The primary efficacy endpoint was incident tuberculosis incorporating microbiological , radiological , and clinical criteria , and the secondary efficacy endpoint was M tuberculosis infection according to QuantiFERON TB Gold In-tube conversion ( Cellestis , Australia ) . This trial was registered with the South African National Clinical Trials Register ( DOH-27 - 0109 - 2654 ) and with Clinical Trials.gov on July 31 , 2009 , number NCT00953927 Findings Between July 15 , 2009 , and May 4 , 2011 , we enrolled 2797 infants ( 1399 allocated MVA85A and 1398 allocated placebo  ) . Median follow-up in the per- protocol population was 24·6 months ( IQR 19·2–28·1 ) , and did not differ between groups . More infants who received MVA85A than controls had at least one local adverse event ( 1251 [ 89 % ] of 1399 MVA85A recipients and 628 [ 45 % ] of 1396 controls who received the allocated intervention ) but the numbers of infants with systemic adverse events ( 1120 [ 80 % ] and 1059 [ 76 % ] ) or serious adverse events ( 257 [ 18 % ] and 258 ( 18 % ) did not differ between groups . None of the 648 serious adverse events in these 515 infants was related to MVA85A . 32 ( 2 % ) of 1399 MVA85A recipients met the primary efficacy endpoint ( tuberculosis incidence of 1·15 per 100 person-years [ 95 % CI 0·79 to 1·62 ] ; with conversion in 178 [ 13 % ] of 1398 infants [ 95 % CI 11·0 to 14·6 ] ) as did 39 ( 3 % ) of 1395 controls ( 1·39 per 100 person-years [ 1·00 to 1·91 ] ; with conversion in 171 [ 12 % ] of 1394 infants [ 10·6 to 14·1 ] ) . Efficacy against tuberculosis was 17·3 % ( 95 % CI −31·9 to 48·2 ) and against M tuberculosis infection was −3·8 % ( –28·1 to 15·9 ) . Interpretation MVA85A was well tolerated and induced modest cell-mediated immune responses . Reasons for the absence  of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants need exploration . Funding Aeras , Wellcome Trust , and Oxford-Emergent Tuberculosis Consortium ( OETC ) The Medical Research Council 's trial of BCG and vole bacillus vaccines in the prevention of  tuberculosis in Great Britain has ended after 20 years ' follow-up of the 54 239 participants , who were aged 14 to 15 years when the entered the trial in 1950 - 2 . Participants who were tuberculin positive on entry were left unvaccinated ; those who were tuberculin negative were allocated at r and om to an unvaccinated or to a vaccinated group . The protective efficacy of each of the two vaccines , among those initially tuberculin negative , was 84 % during the first five years , and gradually decreased , averaging 77 % for each vaccine over the whole period . The incidence of tuberculosis decreased substantially in all groups during the trial , however , and of the total of 610 cases of tuberculosis only 27 developed between 15 and 20 years . Thus we can not make a reliable assessment of efficacy during this final period . The prevalence and incidence of tuberculosis in Great Britain have decreased radically since this trial began . The expected benefit from large-scale BCG-vaccination of children is now far less , and may decrease further if the incidence of tuberculosis continues to decline A clinical trial of B.C.G. and vole bacillus vaccines , directed by the Tuberculosis Vaccines Clinical Trials Committee of the Medical Research Council ( M.R.C. ) , was begun in Engl and in 1950 , and is still in progress . The effect of the vaccines is being studied during adolescence and early adult life in groups with no special risk of exposure to tuberculous infection , and initially free both from active tuberculosis and from known contact with the disease at home . There are more than 50,000 participants of both sexes in the investigation , all aged 14 to 152 years on entry , and now aged between 21 and 23 years . Those with negative reactions to tuberculin on entry were vaccinated with B.C.G. or vole bacillus vaccine or left unvaccinated , according to a method of r and om allocation . All the participants , including those with a positive reaction to tuberculin initially , have now ( January , 1959 ) been followed intensively for more than six years . The first report of this investigation ( M.R.C. , 1956 ; see also Hart , Pollock , and Sutherl and , 1957 ) presented complete results after each participant had been in the trial for two and a half years . The present report gives corresponding results for the period of five years since entry to the trial , together with preliminary incomplete information for the period between five and seven and a half years after entry . The work described was carried out by the Council 's Tuberculosis Research Unit , with the assistance of many statutory and voluntary organizations ( see Acknowledgments ) 
    Output:
    