24801
document
Combined typhoid fever and hepatitis A vaccine : comparison of immunogenicity and safety to concomitant monovalent vaccine over 3 years . BACKGROUND The safety and immunogenicity of Viatim , a combined hepatitis A ( HA ) and typhoid fever ( Vi ) vaccine , were compared with the monovalent component vaccines up to and 1 month after a booster dose at 3 years . METHODS Healthy , adult volunteers were randomized to receive Viatim ( group A , n = 179 ) or separate HA and Vi vaccines ( group B , n = 181 ) ; subgroups were boosted after 3 years with Viatim ( groups C and D , n = 56 and 46 , respectively ) . Local and systemic reactions were recorded for 28 days postvaccination . Seroconversion and seroprotection rates and geometric mean antibody concentrations were measured at 14 and 28 days , 1 , 2 , and 3 years postvaccination , and 28 days after the booster dose . RESULTS Local and systemic safety profiles were equivalent between the two groups . Immediate local reactions were infrequent ( 1 in group A and 2 in group B ) . Local reactions , consisting mostly of mild or moderate pain , were least frequent with monovalent HA . Antibody concentrations to both antigens were similar in groups A and B , in which HA seroprotection rates ( > or = 20 mIU/mL ) were respectively , 98.7 % and 100 % at day 28 , and 99.1 % and 99.0 % after 3 years , achieving 100 % after the booster . Vi seroprotection rates ( > or = 1 microg/mL ) of 85.2 % and 84.9 % after 28 days fell to 32.1 % and 35.6 % after 3 years , increasing to 67.3 % and 69.8 % after the booster dose . CONCLUSIONS The combined HA/Vi vaccine , Viatim , had equivalent tolerability and safety and was as rapidly immunogenic as its component monovalent vaccines when given concurrently . A booster dose after 3 years significantly increased antibody levels with some evidence of relative hyporesponsiveness of the typhoid response .
24802
Intervention_Pharmacological
Combined typhoid fever and hepatitis A vaccine
24803
Intervention_Pharmacological
Viatim
24804
Intervention_Pharmacological
combined hepatitis A ( HA ) and typhoid fever ( Vi ) vaccine
24805
Intervention_Pharmacological
monovalent component vaccines
24806
Intervention_Pharmacological
Viatim
24807
Intervention_Pharmacological
separate HA and Vi vaccines
24808
Intervention_Pharmacological
Viatim
24809
Intervention_Pharmacological
combined HA/Vi vaccine
24810
Intervention_Pharmacological
Viatim
24811
Outcome_Other
safety
24812
Outcome_Other
immunogenicity
24813
Outcome_Physical
Seroconversion
24814
Outcome_Physical
seroprotection rates
24815
Outcome_Physical
geometric mean antibody concentrations
24816
Outcome_Other
Local and systemic safety profiles
24817
Outcome_Adverse-effects
Immediate local reactions
24818
Outcome_Adverse-effects
Local reactions
24819
Outcome_Adverse-effects
mild or moderate pain
24820
Outcome_Physical
Antibody concentrations
24821
Outcome_Physical
HA seroprotection rates
24822
Outcome_Physical
seroprotection rates
24823
Outcome_Other
tolerability and safety and was as rapidly immunogenic
24824
Outcome_Physical
antibody levels
24825
Outcome_Physical
hyporesponsiveness of the typhoid response