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document
Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response . A live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3 was tested in a double-blind randomized placebo controlled study for safety and immunogenicity in 304 men aged between 16 and 50 years from Kolkata , India . A dose of 5 x 10 ( 9 ) CFU ( n=186 ) or a placebo ( n=116 ) containing the diluent buffer was administered . The vaccine did not elicit adverse events except in two vaccine recipients with mild diarrhoea and vomiting . None excreted the vaccine strain . Vibriocidal antibody response developed in 105/186 ( 57 % ) and 5/116 ( 4 % ) in vaccine and placebo recipients , respectively . In a subgroup , anti-CT antibody rose ( > or =2-folds ) in 23/30 ( 77 % ) and 6/19 ( 32 % ) in vaccine and placebo recipients , respectively . These studies demonstrate that VA1.3 at a dose of 5 x 10 ( 9 ) is safe and immunogenic in adults from a cholera endemic region .
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Intervention_Control
placebo
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Intervention_Pharmacological
live oral cholera vaccine VA1.3
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Intervention_Pharmacological
live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
VA1.3
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Outcome_Other
safety
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Outcome_Adverse-effects
adverse events
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Outcome_Adverse-effects
mild diarrhoea and vomiting
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Outcome_Physical
Vibriocidal antibody response
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Outcome_Physical
anti-CT antibody rose
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Outcome_Other
safe and immunogenic
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Participant_Condition
volunteer trial
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Participant_Sample-size
304