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: OBJECTIVE To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria , pertussis , tetanus , and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth . DESIGN R and omized study of infants born to mothers positive for hepatitis B surface antigen ( HBsAg ) and hepatitis Be antigen ( HBeAg ) . SETTING Three large city hospitals and one rural area providing prenatal care and obstetric services . SUBJECTS Eighty neonates of HBsAg- and HBeAg-positive carrier mothers  received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine ( 10 micrograms ) at 0 , 1 , 2 , and 11 months of age ( group A ) or at 3 , 4 , 5 , and 11 months of age concomitant with diphtheria , pertussis , tetanus , and polio immunization ( group B ) . A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months . MAIN OUTCOME MEASURES Blood sample s were collected at 0 , 3 , 6 , 11 , and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg . Follow-up visits were scheduled annually up to 5 years of age . RESULTS Eight infants were excluded from analysis . During the study period , six children became HBsAg carriers , three in each group , which corresponds to a 5-year incidence of infection of 9 % and 8 % for groups A ( three of 35 ) and B ( three of 37 ) , respectively . Sub clinical infections ( persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc ) were encountered in another eight infants ( four in each group ) . CONCLUSION Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age A controlled , r and omized , double-blind trial in 1,083 homosexual men from New York confirmed that a highly purified , formalin-inactivated vaccine against hepatitis B prepared from HBsAg positive plasma , is safe immunogenic , and highly efficacious . Over 95 % of vaccinated subjects developed antibody against the surface antigen . Vaccine-induced antibody persisted for the entire 24-month follow-up period . The attack rate of all hepatitis B virus infections ( excluding conversions of anti-HBc alone ) was 3.2 % in vaccine recipients compared with 25.6 % in placebo recipients ( p less than 0.0001 ) . In those who received all three doses of vaccine , of 40 micrograms each , the protective efficacy rate was close to 100 % . The vaccine protects against acute hepatitis B , asymptomatic infection , and chronic antigenemia . There is reason to assume that the vaccine is also partially effective when given postexposure The feasibility of introducing low dose ( 5 micrograms ) hepatitis B ( HB ) virus vaccination at birth and again 1 and 2 months later as part of an existing primary immunisation programme of childhood , was assessed in 662 healthy newborn Singapore children . The vaccine ( B-Hepavac , Menck , Sharp and Dohme ) was given to three neonatal groups : those born to HB surface antigen (sAg)-negative mothers , HBsAg-positive/HBeAg-positive mothers and HBsAg-positive/HBeAg-negative mothers . A dose of 5 micrograms was compared in a r and omised study with the more usual 10 micrograms dose given at the same intervals . Neonates born to HBsAg-positive/HBeAg-positive mothers were also given hepatitis B immunoglobulin ( HBIg ) at birth . The 5 microgram dose of vaccine was as immunogenic as the 10 microgram dose in all three groups of children studied . At 1 year , anti-HBsAg seroconversion among infants of antigen-negative mothers was 95.8 % for the 5 microgram dose and 91.9 % for the 10 microgram dose . Suppression of anti-HBsAg formation was not seen even when maternal anti-HBsAg was present or HBIg given . Among infants born to HBsAg-positive/HBeAg-positive mothers , passive plus active immunisation was 100 % protective at doses of 5 micrograms and 10 micrograms vaccine in the newborns who were HBsAg-negative at 24 h. Seroconversion after both the 5 and 10 microgram doses of vaccine was reduced , however , to 88 % in each group of infants who were already HBsAg-positive at 24 h of age . Overall , passive plus active immunisation as well as HB vaccine alone ( 5 micrograms dose ) , given within the existing but exp and ed primary immunisation programme of childhood , was effective in preventing infection and the chronic carrier state in newborns exposed to risk of HB virus infection during infancy Infants born to HBsAg-positive women were r and omly assigned to receive either the plasma-derived hepatitis B vaccine or the yeast-derived recombinant hepatitis B vaccine within 12 h of birth , simultaneously with HBIg . The second and third doses of both vaccines were given at 1 and 6 months of age respectively . Two hundred and twenty-two infants received two doses , and 80 infants received three doses of either vaccine . Five infants were found to be HBsAg-positive at 6 months of age . Four of these infants had received the plasma vaccine and the remaining infant the recombinant vaccine .  Anti-HBs was present in all the HBsAg-negative infants at 6 months of age . The titres of anti-HBs were similar in both groups of infants who had received either the plasma or the recombinant hepatitis B vaccine . No major adverse reactions were reported with either vaccine . The preliminary results from this study suggest that the yeast-derived recombinant hepatitis B vaccine is safe , immunogenic and at least as effective as the plasma-derived hepatitis B vaccine in preventing the HBsAg carrier state in infants born to HBsAg-positive women We conducted a r and omized , double-blind clinical trial of an experimental mammalian cell-derived DNA hepatitis B vaccine ( Betagen , Connaught Laboratories Ltd , Toronto , Canada ) to determine its efficacy in infants born to mothers who were carriers of hepatitis B surface antigen ( HBsAg ) . Four groups of 55 infants received injections as follows : ( 1 ) a licensed plasma-derived vaccine ( Lanzhou , Lanzhou Institute for Biological Products , Lanzhou , People 's Republic of China ) , 20 micrograms ; ( 2 ) Betagen , 20 micrograms ; ( 3 ) Betagen , 20 micrograms+hepatitis B immune globulin ( HBIG ) ; and ( 4 ) Betagen , 10 micrograms+HBIG . Vaccine injections were given at birth and at 1 and 6 months and HBIG was given at birth . The vaccines were compared to a historical placebo control group . The efficacy of Betagen alone was 82.6 % compared to 51.0 % for the Lanzhou . Efficacy of Betagen increased with the concomitant use of HBIG . No infants who were HBsAg negative at birth and /or were born to hepatitis B e antigen ( HBeAg ) negative mothers became carriers . The rate of HBsAg in infants receiving Betagen alone , and born to mothers who were HBeAg positive , decreased from 60 % at birth to 20 % by the ninth month , compared to 62.5 % and 50 % ( respectively ) for Lanzhou . The percentage of infants with protective levels of antiHBs was significantly higher for Betagen alone than for Lanzhou , but the geometric mean titre of antiHBs for responders was not significantly different . We have shown that Betagen alone is highly efficacious in preventing the development of hepatitis B in infants born to mothers who are carriers of HBsAg and is also highly effective in reducing the carriage of HBsAg in infants who are HBsAg positive at birth and /or born to HBeAg positive mothers Hepatitis B is a serious disease of global significance . In developing countries , hepatitis B virus ( HBV ) infection and its sequelae rank among the public health problems of highest priority . Infants born to mothers who are chronic carriers of HBV are at particularly high risk of acquiring infection and becoming chronic HBV carriers . The efficacy of hepatitis B vaccine alone in preventing the transmission of HBV to infants born to HBV carrier mothers was determined in a double-blind placebo-controlled trial . Infants received plasma-derived vaccine at birth , 1 month , and 6 months of age . Of 180 infants born to hepatitis B surface antigen (HBsAg)-positive mothers , equal numbers received National Institute of Allergy and Infectious Disease ( NIAID ) vaccine , Beijing Institute of Vaccine and Serum ( BIVS ) vaccine , and placebo . The cumulative seroconversion to the vaccines at 1 year of age was 95 % and 75 % , respectively . Vaccine efficacy as measured by the prevention of HBsAg-positive events was 88 % for the NIAID vaccine and 51 % for the BIVS vaccine . Vaccine efficacy was similar among infants born to hepatitis Be antigen-positive mothers . Because of the low efficacy of the BIVS vaccine , an additional group of 28 infants was given vaccine and hepatitis B immune globulin at birth . The result ing efficacy was 83 % . The results of this trial indicate that hepatitis B vaccine alone can substantially reduce perinatally acquired HBV infection and the result ing chronic carrier state In Taiwan the Hepatitis B virus ( HBV ) carrier rate is 15 % to 20 % . Mother infant transmission plays the most important role in the endemy result ing in 20 % of the children being HBsAg carrier at 4 years of age . A large proportion of HBV carriers will develop a chronic hepatitis leading to cirrhosis and ultimately to primary hepatocellular carcinoma . Children born to HBsAg + /HBeAg + mothers ( 7 % of neonates ) have an estimated risk of 90 % to become HBsAg chronic carriers . A plan for control of Hepatitis B in Taiwan will aim to solve the problem of these children , as a priority . A Hepatitis B vaccine trial has been undertaken in Taiwan since October 1981 in a selected population of children born to HBsAg + /HBeAg + mothers . The purpose of the study was to determine the efficacy of Hepatitis B vaccine alone or in combination with Hepatitis B immunoglobulin  in preventing maternal infant transmission of HBV infection . A three way prophylactic regimen comparison was carried out . Subjects consisted of children born to HBsAg + /HBeAg + mothers . Only mature and apparently healthy neonates were included with the parents ' formal consent based on real knowledge and underst and ing . Babies were r and omly included in four different groups of study A r and omised blind controlled trial of hepatitis B immune globulin ( HBIG ) plus hepatitis B vaccine for the prevention of the perinatally transmitted HBsAg carrier state was conducted in Taipei . Infants of e-antigen-positive HBsAg carrier mothers were given HBIG immediately after birth , and then one of three schedules of vaccination . There was no difference in efficacy between the three schedules ; the combined efficacy was 94 % , compared with that of HBIG alone ( 71 % ) or of vaccination alone ( 75 % ) . Persistent HBs antigenaemia developed in only 9 ( 6 % ) of the 159 infants receiving prophylaxis , but in 88 % of the controls . Antibodies developed in all those who did not become antigenaemic and presumably will provide long-term protection from hepatitis B virus infection . HBIG should be given as soon as possible after birth and need not be given again if the infant is subsequently vaccinated . With HBIG coverage from birth , the timing of the start of vaccination does not seem to be of importance within the first month of life , but to maximise compliance and minimise costs hepatitis B vaccination should be initiated during the confinement 235 infants of HBeAg-carrier mothers in Hong Kong were assigned to four study groups . Groups I , II , and III received hepatitis-B ( HB ) vaccine at birth and at 1 , 2 , and 6 months . Group I also received seven monthly injections of HB immunoglobulin ( HBIg ) , and group II received one HBIg injection at birth . Group III received vaccine only and group IV received placebo for both vaccine and HBIg . At the age of 3 years , all infants of the three treatment groups were significantly protected against the HB virus ( HBV ) carrier state compared with the placebo group ( p less than 0.0001 ) ; the protective efficacy rates in groups I , II , and III were 87 % , 80 % , and 65 % , respectively . At all times , group I was significantly better protected than group III . In groups III and IV , infants of mothers with serum HBV DNA levels of 
    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: OBJECTIVE To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria , pertussis , tetanus , and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth . DESIGN R and omized study of infants born to mothers positive for hepatitis B surface antigen ( HBsAg ) and hepatitis Be antigen ( HBeAg ) . SETTING Three large city hospitals and one rural area providing prenatal care and obstetric services . SUBJECTS Eighty neonates of HBsAg- and HBeAg-positive carrier mothers  received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine ( 10 micrograms ) at 0 , 1 , 2 , and 11 months of age ( group A ) or at 3 , 4 , 5 , and 11 months of age concomitant with diphtheria , pertussis , tetanus , and polio immunization ( group B ) . A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months . MAIN OUTCOME MEASURES Blood sample s were collected at 0 , 3 , 6 , 11 , and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg . Follow-up visits were scheduled annually up to 5 years of age . RESULTS Eight infants were excluded from analysis . During the study period , six children became HBsAg carriers , three in each group , which corresponds to a 5-year incidence of infection of 9 % and 8 % for groups A ( three of 35 ) and B ( three of 37 ) , respectively . Sub clinical infections ( persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc ) were encountered in another eight infants ( four in each group ) . CONCLUSION Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age A controlled , r and omized , double-blind trial in 1,083 homosexual men from New York confirmed that a highly purified , formalin-inactivated vaccine against hepatitis B prepared from HBsAg positive plasma , is safe immunogenic , and highly efficacious . Over 95 % of vaccinated subjects developed antibody against the surface antigen . Vaccine-induced antibody persisted for the entire 24-month follow-up period . The attack rate of all hepatitis B virus infections ( excluding conversions of anti-HBc alone ) was 3.2 % in vaccine recipients compared with 25.6 % in placebo recipients ( p less than 0.0001 ) . In those who received all three doses of vaccine , of 40 micrograms each , the protective efficacy rate was close to 100 % . The vaccine protects against acute hepatitis B , asymptomatic infection , and chronic antigenemia . There is reason to assume that the vaccine is also partially effective when given postexposure The feasibility of introducing low dose ( 5 micrograms ) hepatitis B ( HB ) virus vaccination at birth and again 1 and 2 months later as part of an existing primary immunisation programme of childhood , was assessed in 662 healthy newborn Singapore children . The vaccine ( B-Hepavac , Menck , Sharp and Dohme ) was given to three neonatal groups : those born to HB surface antigen (sAg)-negative mothers , HBsAg-positive/HBeAg-positive mothers and HBsAg-positive/HBeAg-negative mothers . A dose of 5 micrograms was compared in a r and omised study with the more usual 10 micrograms dose given at the same intervals . Neonates born to HBsAg-positive/HBeAg-positive mothers were also given hepatitis B immunoglobulin ( HBIg ) at birth . The 5 microgram dose of vaccine was as immunogenic as the 10 microgram dose in all three groups of children studied . At 1 year , anti-HBsAg seroconversion among infants of antigen-negative mothers was 95.8 % for the 5 microgram dose and 91.9 % for the 10 microgram dose . Suppression of anti-HBsAg formation was not seen even when maternal anti-HBsAg was present or HBIg given . Among infants born to HBsAg-positive/HBeAg-positive mothers , passive plus active immunisation was 100 % protective at doses of 5 micrograms and 10 micrograms vaccine in the newborns who were HBsAg-negative at 24 h. Seroconversion after both the 5 and 10 microgram doses of vaccine was reduced , however , to 88 % in each group of infants who were already HBsAg-positive at 24 h of age . Overall , passive plus active immunisation as well as HB vaccine alone ( 5 micrograms dose ) , given within the existing but exp and ed primary immunisation programme of childhood , was effective in preventing infection and the chronic carrier state in newborns exposed to risk of HB virus infection during infancy Infants born to HBsAg-positive women were r and omly assigned to receive either the plasma-derived hepatitis B vaccine or the yeast-derived recombinant hepatitis B vaccine within 12 h of birth , simultaneously with HBIg . The second and third doses of both vaccines were given at 1 and 6 months of age respectively . Two hundred and twenty-two infants received two doses , and 80 infants received three doses of either vaccine . Five infants were found to be HBsAg-positive at 6 months of age . Four of these infants had received the plasma vaccine and the remaining infant the recombinant vaccine .  Anti-HBs was present in all the HBsAg-negative infants at 6 months of age . The titres of anti-HBs were similar in both groups of infants who had received either the plasma or the recombinant hepatitis B vaccine . No major adverse reactions were reported with either vaccine . The preliminary results from this study suggest that the yeast-derived recombinant hepatitis B vaccine is safe , immunogenic and at least as effective as the plasma-derived hepatitis B vaccine in preventing the HBsAg carrier state in infants born to HBsAg-positive women We conducted a r and omized , double-blind clinical trial of an experimental mammalian cell-derived DNA hepatitis B vaccine ( Betagen , Connaught Laboratories Ltd , Toronto , Canada ) to determine its efficacy in infants born to mothers who were carriers of hepatitis B surface antigen ( HBsAg ) . Four groups of 55 infants received injections as follows : ( 1 ) a licensed plasma-derived vaccine ( Lanzhou , Lanzhou Institute for Biological Products , Lanzhou , People 's Republic of China ) , 20 micrograms ; ( 2 ) Betagen , 20 micrograms ; ( 3 ) Betagen , 20 micrograms+hepatitis B immune globulin ( HBIG ) ; and ( 4 ) Betagen , 10 micrograms+HBIG . Vaccine injections were given at birth and at 1 and 6 months and HBIG was given at birth . The vaccines were compared to a historical placebo control group . The efficacy of Betagen alone was 82.6 % compared to 51.0 % for the Lanzhou . Efficacy of Betagen increased with the concomitant use of HBIG . No infants who were HBsAg negative at birth and /or were born to hepatitis B e antigen ( HBeAg ) negative mothers became carriers . The rate of HBsAg in infants receiving Betagen alone , and born to mothers who were HBeAg positive , decreased from 60 % at birth to 20 % by the ninth month , compared to 62.5 % and 50 % ( respectively ) for Lanzhou . The percentage of infants with protective levels of antiHBs was significantly higher for Betagen alone than for Lanzhou , but the geometric mean titre of antiHBs for responders was not significantly different . We have shown that Betagen alone is highly efficacious in preventing the development of hepatitis B in infants born to mothers who are carriers of HBsAg and is also highly effective in reducing the carriage of HBsAg in infants who are HBsAg positive at birth and /or born to HBeAg positive mothers Hepatitis B is a serious disease of global significance . In developing countries , hepatitis B virus ( HBV ) infection and its sequelae rank among the public health problems of highest priority . Infants born to mothers who are chronic carriers of HBV are at particularly high risk of acquiring infection and becoming chronic HBV carriers . The efficacy of hepatitis B vaccine alone in preventing the transmission of HBV to infants born to HBV carrier mothers was determined in a double-blind placebo-controlled trial . Infants received plasma-derived vaccine at birth , 1 month , and 6 months of age . Of 180 infants born to hepatitis B surface antigen (HBsAg)-positive mothers , equal numbers received National Institute of Allergy and Infectious Disease ( NIAID ) vaccine , Beijing Institute of Vaccine and Serum ( BIVS ) vaccine , and placebo . The cumulative seroconversion to the vaccines at 1 year of age was 95 % and 75 % , respectively . Vaccine efficacy as measured by the prevention of HBsAg-positive events was 88 % for the NIAID vaccine and 51 % for the BIVS vaccine . Vaccine efficacy was similar among infants born to hepatitis Be antigen-positive mothers . Because of the low efficacy of the BIVS vaccine , an additional group of 28 infants was given vaccine and hepatitis B immune globulin at birth . The result ing efficacy was 83 % . The results of this trial indicate that hepatitis B vaccine alone can substantially reduce perinatally acquired HBV infection and the result ing chronic carrier state In Taiwan the Hepatitis B virus ( HBV ) carrier rate is 15 % to 20 % . Mother infant transmission plays the most important role in the endemy result ing in 20 % of the children being HBsAg carrier at 4 years of age . A large proportion of HBV carriers will develop a chronic hepatitis leading to cirrhosis and ultimately to primary hepatocellular carcinoma . Children born to HBsAg + /HBeAg + mothers ( 7 % of neonates ) have an estimated risk of 90 % to become HBsAg chronic carriers . A plan for control of Hepatitis B in Taiwan will aim to solve the problem of these children , as a priority . A Hepatitis B vaccine trial has been undertaken in Taiwan since October 1981 in a selected population of children born to HBsAg + /HBeAg + mothers . The purpose of the study was to determine the efficacy of Hepatitis B vaccine alone or in combination with Hepatitis B immunoglobulin  in preventing maternal infant transmission of HBV infection . A three way prophylactic regimen comparison was carried out . Subjects consisted of children born to HBsAg + /HBeAg + mothers . Only mature and apparently healthy neonates were included with the parents ' formal consent based on real knowledge and underst and ing . Babies were r and omly included in four different groups of study A r and omised blind controlled trial of hepatitis B immune globulin ( HBIG ) plus hepatitis B vaccine for the prevention of the perinatally transmitted HBsAg carrier state was conducted in Taipei . Infants of e-antigen-positive HBsAg carrier mothers were given HBIG immediately after birth , and then one of three schedules of vaccination . There was no difference in efficacy between the three schedules ; the combined efficacy was 94 % , compared with that of HBIG alone ( 71 % ) or of vaccination alone ( 75 % ) . Persistent HBs antigenaemia developed in only 9 ( 6 % ) of the 159 infants receiving prophylaxis , but in 88 % of the controls . Antibodies developed in all those who did not become antigenaemic and presumably will provide long-term protection from hepatitis B virus infection . HBIG should be given as soon as possible after birth and need not be given again if the infant is subsequently vaccinated . With HBIG coverage from birth , the timing of the start of vaccination does not seem to be of importance within the first month of life , but to maximise compliance and minimise costs hepatitis B vaccination should be initiated during the confinement 235 infants of HBeAg-carrier mothers in Hong Kong were assigned to four study groups . Groups I , II , and III received hepatitis-B ( HB ) vaccine at birth and at 1 , 2 , and 6 months . Group I also received seven monthly injections of HB immunoglobulin ( HBIg ) , and group II received one HBIg injection at birth . Group III received vaccine only and group IV received placebo for both vaccine and HBIg . At the age of 3 years , all infants of the three treatment groups were significantly protected against the HB virus ( HBV ) carrier state compared with the placebo group ( p less than 0.0001 ) ; the protective efficacy rates in groups I , II , and III were 87 % , 80 % , and 65 % , respectively . At all times , group I was significantly better protected than group III . In groups III and IV , infants of mothers with serum HBV DNA levels of 
    Output:
    