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 A two dose schedule ( 0 and 6 months ) for a combined hepatitis A and B vaccine is currently being developed . METHODS The present study compared the combined hepatitis A and B vaccines in 12 - 15-year-old : Twinrix paediatric ( 360 EL.U HAV antigen/10 microg HBs antigen ) on a three dose schedule ( 0 , 1 and 6 months ) to the adult formulation ( 720 EL.U HAV antigen/20 microg HBs antigen ) on a two dose schedule ( 0 and 6 months ) and also reports on the follow-up until 24 months . RESULTS Seroconversion ( SC ) rates to HAV in both regimens reached 100 % by month 7 and remained 100 % up to month 24 . Anti-HAV , GMTs were slightly higher for the two dose than the three dose regimens at this time point . Seroprotection against hepatitis B was > 99 % in both groups by month 7 and 24 , this was still 94 and 96 % , respectively . Statistical non-inferiority of group 1 ( two dose ) versus group 2 ( three dose ) was demonstrated . All vaccines were well tolerated and the most frequently reported local and general symptoms were pain and fatigue . There were no vaccine-related serious adverse events reported during the study . CONCLUSION The two dose regimen elicited similar immunogenicity to HAV and HBsAg and reactogenicity profiles as the three dose regimen in this group of healthy adolescents . The reduction in the number of doses from the current three dose schedule will make vaccination against hepatitis A and B more convenient to the vaccinee , reduce healthcare staff time required and may lower the overall costs associated with vaccination The co-administration of the tetravalent meningococcal conjugate vaccine , MenACWY-TT , with a licensed hepatitis A and B vaccine , HepA/B ( Twinrix ( ® ) ) , was compared to their separate administration in this open , r and omised , controlled study . Healthy subjects 11 - 17 years of age ( n=611 ) were r and omised ( 3:1:1 ) to receive both vaccines , MenACWY-TT alone or HepA/B alone . The co-administration of both vaccines was shown to be non-inferior to their individual administration . At seven months after the first vaccination , 99.4 - 100 % of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1 % of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity , safety and reactogenicity of either of the vaccines BACKGROUND Immunization against hepatitis A and B has been available for some time , protecting against both infections . With a view to achieving further reduction in the number of interventions and increasing convenience of the vaccinee , we investigated the reactogenicity and immunogenicity of a combined hepatitis A and B vaccine in healthy 4- to 20-year-old subjects at a 0 , 6-month schedule . METHODS Two hundred forty-eight study subjects were allocated to two study groups and received either two doses of the combined hepatitis A and B vaccine ( 68 % of subjects ) or the corresponding monovalent hepatitis A and hepatitis B vaccines ( 32 % of subjects ) concomitantly in opposite arms . Reactogenicity was assessed via diary cards after each vaccination . Serum sample s were analyzed at months 1 , 2 , 6 , and 7 . RESULTS All vaccines were well tolerated and very few symptoms were scored as severe . All but one subject seroconverted for anti-hepatitis A virus ( anti-HAV ) antibodies ( 98.6 % ) and 100 % of subjects seroconverted for anti-hepatitis B ( HBs ) antibodies , with respective seroprotection rates of 98.7 % for the combined vaccine group and 95.9 % for the concomitant vaccine group ( p > 0.05 ) , respectively . Geometric mean titers were higher in the group receiving the combined vaccine : 6,635 mIU/mL vs. 2,728 mIU/mL ( p = 0.0001 ) for anti-HAV and 3,362 mIU/mL vs. 1,724 mIU/mL ( p = 0.0205 ) for anti-HBs , respectively . Younger subjects had a stronger immune response compared to older subjects . CONCLUSIONS The combined hepatitis A and B vaccine was well tolerated at this two-dose schedule . The combined vaccine had higher immunogenicity , probably explained by a adjuvant effect of the antigens . Vaccination programs requiring fewer injections will most likely have a positive impact on compliance rate and comfort of the vaccinee Challenged by contrasting data on low immune responses in the elderly with a combined hepatitis A/B vaccine  , a r and omised , controlled study was conducted to assess the immunogenicity of three hepatitis A and B vaccination regimens ( group 1 : combined hepatitis A/B vaccine Twinrix [ GSK ] ; group 2 : co-administered hepatitis A vaccine , Havrix [GSK]+hepatitis B vaccine Engerix -B [ GSK ] , group 3 : co-administered hepatitis A vaccine , Vaqta [ Sanofi-Pasteur MSD]+hepatitis B vaccine HB VAX PRO [ Sanofi-Pasteur MSD ] ) and the effect of influencing factors in subjects > 40 years . On completion of the full vaccination course , anti-HBs seroprotection ( SP ) rates were 92 , 80 and 71 % in groups 1 , 2 and 3 , respectively ; anti-HAV seropositivity ( S+ ) rates were 97 , 99 and 99 % , respectively . In group 1 , anti-HBs SP rate was non-inferior as well as superior and anti-HAV S+ rate was non-inferior to that in groups 2 and 3 . Anti-HBs response was most significantly influenced by the vaccine regimen , followed by age , gender and BMI ( stepwise multiple regression analysis ) . BMI had the most significant influence on HAV response followed by age , gender and vaccine regimen . In conclusion , Twinrix induced superior hepatitis B SP rates and similar hepatitis A S+ rates compared to concomitant administration of monovalent vaccines in subjects aged > 40 years A r and omized trial comparing 3 manufacturing consistency lots of a combination hepatitis A/hepatitis B vaccine to each other and to hepatitis A vaccine and hepatitis B vaccine given separately and concurrently was done to evaluate safety , tolerability , and immunogenicity .  Healthy volunteers > /=11 years of age were divided into 4 groups . Each of 3 groups received a separate consistency lot of the combination vaccine , and 1 group received separate but concurrent injections of hepatitis A and hepatitis B vaccines . Injections were given at weeks 0 and 24 . The combination vaccine was generally well tolerated . The hepatitis A portion of the combination vaccine produced clinical ly acceptable high seropositivity rates 4 and 52 weeks after the first injection . The hepatitis B portion of the vaccine did not produce clinical ly acceptable seropositivity rates 4 weeks after the second injection . Lack of antibody production may be attributed , at least in part , to immunologic interference The immunogenicity of three currently used hepatitis B vaccines was compared in an unselected study population in an every day travel clinical setting . Five hundred and eighteen vaccinees received Engerix-B ( EB ) , 990 received Twinrix ( TWX ) , and  366 were immunised with Gen-HB-Vax ( GHB ) . Overall , 88.6 % of the vaccinees , tested within the first 6 months after completion of the vaccination series , developed protective levels of anti-HBs ( > or = 10 mIU/ml ) . However , GHB recipients showed significantly lower seroprotection rates ( SPR ) than EB and TWX recipients ( 79.3 % vs. 87.7 % vs. 92.3 % , P < 0.000001 ) . GMTs for anti-HBs , tested within 6 months after the third vaccination , showed the lowest results in the GHB group , followed by EB and TWX ( 142 vs. 523 vs. 1008 mIU/ml , P < 0.000001 ) . TWX vaccinees , however , showing a higher antibody decline rate than EB recipients within the first years after completion of the full immunisation course ( 30 % vs. 25 % ; P = 0.0538 ) . This study confirms an overall good immune response to the 20 microg-dose vaccine , in the course of a regular clinical setting . The significant difference in SPRs and GMTs to the 10 microg-dose vaccine , however , may influence future immunisation practice s for the elderly An open , r and omised study was undertaken to demonstrate the equivalence in immunogenicity and to determine the reactogenicity and safety of two dosing schedules ( 0 , 6 or 0 , 12 month ) of an adult formulation of a combined hepatitis A and B vaccine containing 720 EL.U. of inactivated hepatitis A antigen and 20 microg of hepatitis B surface antigen ( Twinrix , SmithKline Beecham Biologicals , Belgium ) in 240 healthy volunteers aged 12 - 15 years . The vaccine was well tolerated when administered using either vaccination schedule . At month 7 , 98.1 % of subjects completing the 0 , 6 month vaccination schedule were seroprotected against hepatitis B ( anti-hepatitis B surface antigen ( anti-HBs ) > or = 10 mIU/ml ) and 100 % were seropositive for anti-hepatitis A virus ( anti-HAV ) antibodies ( i.e. , > or = 33 mIU/ml ) . The corresponding geometric mean titres ( GMTs ) were 2791 mIU/ml for anti-HBs and 5992 mIU/ml for anti-HAV antibodies . At month 13 , 97 % of subjects assigned to the 0 , 12 month vaccination schedule were protected against hepatitis B and 99 % were seropositive for anti-HAV antibodies . The corresponding GMTs were 4340 and 8472 mIU/ml , respectively . A combined response ( i.e. , subjects , who were seropositive for anti-HAV antibodies and seroprotected for anti-HBs antibodies ) was achieved in 98 % of subjects vaccinated according to the 0 , 6 month interval and in 96 % of subjects vaccinated using the 0 , 12 month schedule . The reactogenicity of both vaccination schedules was also equivalent . The results thus show that the combined hepatitis A and B vaccine can be administered using flexible vaccination intervals , which make it suitable for use in large-scale hepatitis immunisation programmes Background : HIV-infected youth are at risk of hepatitis B infection and should be vaccinated . Previous reports suggest reduced response to st and ard hepatitis B vaccine regimens . Methods : HIV-infected youth , aged 12 to younger than 25 years , were r and omly assigned to one of three treatment arms : Arm 1 : Engerix B , 20 μg HBsAg ; Arm 2 : Engerix B ( GlaxoSmithKline , Rixensart , Belgium ) , 40 μg ; and Arm 3 : Twinrix ( GlaxoSmithKline , Rixensart , Belgium ) , 20 μg HBsAg combined with 720 ELU hepatitis A antigen . Vaccines were administered at Weeks 0 , 4 , and 24 . Results : Characteristics of evaluable patients ( n = 336 ) at entry were similar in the study arms . At enrollment , median CD4 + T-cell count was 460 cells/mm3 ( interquartile range , 305 - 668 ) ; 13 % were less than 200 cells/mm3 . Among Engerix B , 20-μg recipients , 60.4 % responded to vaccine ( HBsAb 10 IU/mL or greater at Week 28 ) . Improved vaccine response was seen in recipients of Engerix B , 40 μg ( 73.2 % versus Arm 1 , P = 0.04 ) and Twinrix ( 75.4 % versus Arm 1 , P = 0.02 ) . In multivariate analysis , only baseline CD4 + T-cell count and study arm were independent predictors of vaccine response . Conclusions : In HIV-infected youth , a three-dose vaccination regimen with Engerix B , 40 μg , or Twinrix and higher baseline CD4 + T-cell counts were independently associated with improved vaccine response Background : Multiple studies have shown excellent response rates after hepatitis B immunization in youth ; however , one previous study conducted in urban youth demonstrated poor responses . Methods : Urban youth , ages 12 to 17 years , at participating Adolescent Medicine Trials Network for HIV/AIDS Interventions Clinical / Research 
    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 A two dose schedule ( 0 and 6 months ) for a combined hepatitis A and B vaccine is currently being developed . METHODS The present study compared the combined hepatitis A and B vaccines in 12 - 15-year-old : Twinrix paediatric ( 360 EL.U HAV antigen/10 microg HBs antigen ) on a three dose schedule ( 0 , 1 and 6 months ) to the adult formulation ( 720 EL.U HAV antigen/20 microg HBs antigen ) on a two dose schedule ( 0 and 6 months ) and also reports on the follow-up until 24 months . RESULTS Seroconversion ( SC ) rates to HAV in both regimens reached 100 % by month 7 and remained 100 % up to month 24 . Anti-HAV , GMTs were slightly higher for the two dose than the three dose regimens at this time point . Seroprotection against hepatitis B was > 99 % in both groups by month 7 and 24 , this was still 94 and 96 % , respectively . Statistical non-inferiority of group 1 ( two dose ) versus group 2 ( three dose ) was demonstrated . All vaccines were well tolerated and the most frequently reported local and general symptoms were pain and fatigue . There were no vaccine-related serious adverse events reported during the study . CONCLUSION The two dose regimen elicited similar immunogenicity to HAV and HBsAg and reactogenicity profiles as the three dose regimen in this group of healthy adolescents . The reduction in the number of doses from the current three dose schedule will make vaccination against hepatitis A and B more convenient to the vaccinee , reduce healthcare staff time required and may lower the overall costs associated with vaccination The co-administration of the tetravalent meningococcal conjugate vaccine , MenACWY-TT , with a licensed hepatitis A and B vaccine , HepA/B ( Twinrix ( ® ) ) , was compared to their separate administration in this open , r and omised , controlled study . Healthy subjects 11 - 17 years of age ( n=611 ) were r and omised ( 3:1:1 ) to receive both vaccines , MenACWY-TT alone or HepA/B alone . The co-administration of both vaccines was shown to be non-inferior to their individual administration . At seven months after the first vaccination , 99.4 - 100 % of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1 % of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity , safety and reactogenicity of either of the vaccines BACKGROUND Immunization against hepatitis A and B has been available for some time , protecting against both infections . With a view to achieving further reduction in the number of interventions and increasing convenience of the vaccinee , we investigated the reactogenicity and immunogenicity of a combined hepatitis A and B vaccine in healthy 4- to 20-year-old subjects at a 0 , 6-month schedule . METHODS Two hundred forty-eight study subjects were allocated to two study groups and received either two doses of the combined hepatitis A and B vaccine ( 68 % of subjects ) or the corresponding monovalent hepatitis A and hepatitis B vaccines ( 32 % of subjects ) concomitantly in opposite arms . Reactogenicity was assessed via diary cards after each vaccination . Serum sample s were analyzed at months 1 , 2 , 6 , and 7 . RESULTS All vaccines were well tolerated and very few symptoms were scored as severe . All but one subject seroconverted for anti-hepatitis A virus ( anti-HAV ) antibodies ( 98.6 % ) and 100 % of subjects seroconverted for anti-hepatitis B ( HBs ) antibodies , with respective seroprotection rates of 98.7 % for the combined vaccine group and 95.9 % for the concomitant vaccine group ( p > 0.05 ) , respectively . Geometric mean titers were higher in the group receiving the combined vaccine : 6,635 mIU/mL vs. 2,728 mIU/mL ( p = 0.0001 ) for anti-HAV and 3,362 mIU/mL vs. 1,724 mIU/mL ( p = 0.0205 ) for anti-HBs , respectively . Younger subjects had a stronger immune response compared to older subjects . CONCLUSIONS The combined hepatitis A and B vaccine was well tolerated at this two-dose schedule . The combined vaccine had higher immunogenicity , probably explained by a adjuvant effect of the antigens . Vaccination programs requiring fewer injections will most likely have a positive impact on compliance rate and comfort of the vaccinee Challenged by contrasting data on low immune responses in the elderly with a combined hepatitis A/B vaccine  , a r and omised , controlled study was conducted to assess the immunogenicity of three hepatitis A and B vaccination regimens ( group 1 : combined hepatitis A/B vaccine Twinrix [ GSK ] ; group 2 : co-administered hepatitis A vaccine , Havrix [GSK]+hepatitis B vaccine Engerix -B [ GSK ] , group 3 : co-administered hepatitis A vaccine , Vaqta [ Sanofi-Pasteur MSD]+hepatitis B vaccine HB VAX PRO [ Sanofi-Pasteur MSD ] ) and the effect of influencing factors in subjects > 40 years . On completion of the full vaccination course , anti-HBs seroprotection ( SP ) rates were 92 , 80 and 71 % in groups 1 , 2 and 3 , respectively ; anti-HAV seropositivity ( S+ ) rates were 97 , 99 and 99 % , respectively . In group 1 , anti-HBs SP rate was non-inferior as well as superior and anti-HAV S+ rate was non-inferior to that in groups 2 and 3 . Anti-HBs response was most significantly influenced by the vaccine regimen , followed by age , gender and BMI ( stepwise multiple regression analysis ) . BMI had the most significant influence on HAV response followed by age , gender and vaccine regimen . In conclusion , Twinrix induced superior hepatitis B SP rates and similar hepatitis A S+ rates compared to concomitant administration of monovalent vaccines in subjects aged > 40 years A r and omized trial comparing 3 manufacturing consistency lots of a combination hepatitis A/hepatitis B vaccine to each other and to hepatitis A vaccine and hepatitis B vaccine given separately and concurrently was done to evaluate safety , tolerability , and immunogenicity .  Healthy volunteers > /=11 years of age were divided into 4 groups . Each of 3 groups received a separate consistency lot of the combination vaccine , and 1 group received separate but concurrent injections of hepatitis A and hepatitis B vaccines . Injections were given at weeks 0 and 24 . The combination vaccine was generally well tolerated . The hepatitis A portion of the combination vaccine produced clinical ly acceptable high seropositivity rates 4 and 52 weeks after the first injection . The hepatitis B portion of the vaccine did not produce clinical ly acceptable seropositivity rates 4 weeks after the second injection . Lack of antibody production may be attributed , at least in part , to immunologic interference The immunogenicity of three currently used hepatitis B vaccines was compared in an unselected study population in an every day travel clinical setting . Five hundred and eighteen vaccinees received Engerix-B ( EB ) , 990 received Twinrix ( TWX ) , and  366 were immunised with Gen-HB-Vax ( GHB ) . Overall , 88.6 % of the vaccinees , tested within the first 6 months after completion of the vaccination series , developed protective levels of anti-HBs ( > or = 10 mIU/ml ) . However , GHB recipients showed significantly lower seroprotection rates ( SPR ) than EB and TWX recipients ( 79.3 % vs. 87.7 % vs. 92.3 % , P < 0.000001 ) . GMTs for anti-HBs , tested within 6 months after the third vaccination , showed the lowest results in the GHB group , followed by EB and TWX ( 142 vs. 523 vs. 1008 mIU/ml , P < 0.000001 ) . TWX vaccinees , however , showing a higher antibody decline rate than EB recipients within the first years after completion of the full immunisation course ( 30 % vs. 25 % ; P = 0.0538 ) . This study confirms an overall good immune response to the 20 microg-dose vaccine , in the course of a regular clinical setting . The significant difference in SPRs and GMTs to the 10 microg-dose vaccine , however , may influence future immunisation practice s for the elderly An open , r and omised study was undertaken to demonstrate the equivalence in immunogenicity and to determine the reactogenicity and safety of two dosing schedules ( 0 , 6 or 0 , 12 month ) of an adult formulation of a combined hepatitis A and B vaccine containing 720 EL.U. of inactivated hepatitis A antigen and 20 microg of hepatitis B surface antigen ( Twinrix , SmithKline Beecham Biologicals , Belgium ) in 240 healthy volunteers aged 12 - 15 years . The vaccine was well tolerated when administered using either vaccination schedule . At month 7 , 98.1 % of subjects completing the 0 , 6 month vaccination schedule were seroprotected against hepatitis B ( anti-hepatitis B surface antigen ( anti-HBs ) > or = 10 mIU/ml ) and 100 % were seropositive for anti-hepatitis A virus ( anti-HAV ) antibodies ( i.e. , > or = 33 mIU/ml ) . The corresponding geometric mean titres ( GMTs ) were 2791 mIU/ml for anti-HBs and 5992 mIU/ml for anti-HAV antibodies . At month 13 , 97 % of subjects assigned to the 0 , 12 month vaccination schedule were protected against hepatitis B and 99 % were seropositive for anti-HAV antibodies . The corresponding GMTs were 4340 and 8472 mIU/ml , respectively . A combined response ( i.e. , subjects , who were seropositive for anti-HAV antibodies and seroprotected for anti-HBs antibodies ) was achieved in 98 % of subjects vaccinated according to the 0 , 6 month interval and in 96 % of subjects vaccinated using the 0 , 12 month schedule . The reactogenicity of both vaccination schedules was also equivalent . The results thus show that the combined hepatitis A and B vaccine can be administered using flexible vaccination intervals , which make it suitable for use in large-scale hepatitis immunisation programmes Background : HIV-infected youth are at risk of hepatitis B infection and should be vaccinated . Previous reports suggest reduced response to st and ard hepatitis B vaccine regimens . Methods : HIV-infected youth , aged 12 to younger than 25 years , were r and omly assigned to one of three treatment arms : Arm 1 : Engerix B , 20 μg HBsAg ; Arm 2 : Engerix B ( GlaxoSmithKline , Rixensart , Belgium ) , 40 μg ; and Arm 3 : Twinrix ( GlaxoSmithKline , Rixensart , Belgium ) , 20 μg HBsAg combined with 720 ELU hepatitis A antigen . Vaccines were administered at Weeks 0 , 4 , and 24 . Results : Characteristics of evaluable patients ( n = 336 ) at entry were similar in the study arms . At enrollment , median CD4 + T-cell count was 460 cells/mm3 ( interquartile range , 305 - 668 ) ; 13 % were less than 200 cells/mm3 . Among Engerix B , 20-μg recipients , 60.4 % responded to vaccine ( HBsAb 10 IU/mL or greater at Week 28 ) . Improved vaccine response was seen in recipients of Engerix B , 40 μg ( 73.2 % versus Arm 1 , P = 0.04 ) and Twinrix ( 75.4 % versus Arm 1 , P = 0.02 ) . In multivariate analysis , only baseline CD4 + T-cell count and study arm were independent predictors of vaccine response . Conclusions : In HIV-infected youth , a three-dose vaccination regimen with Engerix B , 40 μg , or Twinrix and higher baseline CD4 + T-cell counts were independently associated with improved vaccine response Background : Multiple studies have shown excellent response rates after hepatitis B immunization in youth ; however , one previous study conducted in urban youth demonstrated poor responses . Methods : Urban youth , ages 12 to 17 years , at participating Adolescent Medicine Trials Network for HIV/AIDS Interventions Clinical / Research 
    Output:
    