87705
document
Randomized controlled trial of acellular diphtheria , pertussis and tetanus vaccines in southern Ghana . A randomized controlled trial of acellular diphtheria/pertussis/tetanus ( ADPT ) freeze-dried and liquid vaccines in infants was conducted in a peri-urban community ( Ashaiman ) in southern Ghana . Immunogenicity of the acellular vaccines , persistence of antibodies and adverse reactions were compared with those achieved with a whole-cell diphtheria-pertussis-tetanus ( DPT ) vaccine . The incidence of pertussis in the vaccine groups and prevalence of pertussis in children under 5 years of age in the study area were also determined . The acellular vaccines produced significantly fewer local and systemic reactions . Local reactions such as swelling and redness were observed in 2 % ( 8/399 ) to 2.3 % ( 9/385 ) of the acellular vaccine recipients as against 31 % ( 122/394 ) in the whole-cell vaccine group . Fever ( > or = 37.5 degrees C ) occurred in 7.27 % ( 29/399 ) to 9.8 % ( 38/385 ) in the acellular vaccine groups compared with 36.6 % ( 145/394 ) in the whole-cell vaccine group . Geometric mean titres ( GMTs ) , measured by ELISA , to pertussis toxin ( PT ) and filamentous haemagglutinin ( FHA ) were significantly higher in the acellular vaccine groups than in the whole-cell DPT ( WCDPT ) group . There were no significant differences in the GMTs of tetanus and diphtheria antitoxins between the two groups after each vaccination . Twelve months after primary vaccination , GMTs to PT in the freeze-dried , liquid ADPT groups and the WCDPT group have fallen from 56.23 , 62.63 and 44.97 ELISA U/ml to 6.08 , 6.18 and 11.30 ELISA U/ml , respectively . GMTs to FHA in all the vaccine groups also dropped during the same period from 49.94 , 41.73 and 20.74 ELISA U/ml to 7.26 , 7.72 and 5.91 ELISA U/ml , respectively . In this comparative controlled trial , the ADPT vaccines were more immunogenic , with less local and systemic reactions , than the WCDPT vaccine but there was a considerable drop in antibody titres in all the vaccine groups 12 months after primary vaccination . However , the levels of titres of anti-PT and anti-FHA antibodies in all the three vaccines that confer protection are not known . Further studies are necessary to provide this information in order to assess the need for subsequent booster doses after primary immunization with both ADPT and WCDPT vaccines .
87706
Intervention_Pharmacological
acellular diphtheria , pertussis and tetanus vaccines
87707
Intervention_Pharmacological
acellular diphtheria/pertussis/tetanus ( ADPT ) freeze-dried and liquid vaccines
87708
Intervention_Pharmacological
whole-cell diphtheria-pertussis-tetanus ( DPT ) vaccine .
87709
Intervention_Pharmacological
acellular vaccine
87710
Intervention_Pharmacological
acellular vaccine
87711
Intervention_Pharmacological
acellular vaccine
87712
Intervention_Physical
whole-cell DPT ( WCDPT )
87713
Intervention_Pharmacological
ADPT vaccines
87714
Intervention_Pharmacological
WCDPT vaccine
87715
Outcome_Other
vaccines
87716
Outcome_Physical
Immunogenicity
87717
Outcome_Adverse-effects
local and systemic reactions .
87718
Outcome_Adverse-effects
swelling and redness
87719
Outcome_Adverse-effects
Fever
87720
Outcome_Physical
Geometric mean titres ( GMTs )
87721
Outcome_Other
ELISA
87722
Outcome_Physical
pertussis toxin ( PT ) and filamentous haemagglutinin ( FHA )
87723
Outcome_Physical
GMTs of tetanus and diphtheria antitoxins
87724
Outcome_Physical
GMTs to PT
87725
Outcome_Physical
GMTs to FHA
87726
Outcome_Physical
immunogenic
87727
Outcome_Physical
antibody titres
87728
Outcome_Physical
anti-PT and anti-FHA antibodies
87729
Participant_Condition
diphtheria/pertussis/tetanus
87730
Participant_Age
infants
87731
Participant_Condition
pertussis
87732
Participant_Age
children
87733
Participant_Age
5
87734
Participant_Sample-size
2 %
87735
Participant_Sample-size
2.3 %
87736
Participant_Sample-size
31 %