Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
Seroefficacy of Vi Polysaccharide-Tetanus Toxoid Typhoid Conjugate Vaccine (Typbar TCV).
Клиническое исследование III фазыСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Voysey Merryn, Pollard Andrew J
Аннотация
BACKGROUND: Salmonella Typhi is the major cause of enteric fever in lower-income countries. New conjugate vaccines show promise as public health interventions, but there are no efficacy data available from endemic areas.
METHODS: Data were obtained from a previously published phase 3 randomized controlled trial comparing Vi polysaccharide-tetanus toxoid conjugate vaccine (Vi-TT) with Vi polysaccharide vaccine (Vi-PS) in participants aged 2-45 years. An additional open-label arm administered Vi-TT to children aged 6-23 months. The proportion of participants with presumed clinical or subclinical infection ("seroincidence") was determined using mixture models and compared using relative risks (RRs).
RESULTS: Of 387 participants, 81 (21%) were classified as having presumed typhoid infection during the 2-year postvaccination period. Seroincidence was lower in participants randomized to Vi-TT rather than Vi-PS among those aged 2-45 years (RR, 0.372; 95% confidence interval [CI], .235-.588; P < .001) and those aged 2-15 years (RR, 0.424; 95% CI, .231-.778; P = .004). There was no difference in seroincidence for Vi-TT between those aged 2-45 years and those aged 6-23 months (RR, 1.073; 95% CI, .563-2.046; P = .83). Vaccine seroefficacy was 85% (95% CI, 80%-88%).
CONCLUSION: This is the first field estimate of the seroefficacy of a Vi-TT vaccine and shows that Typbar TCV substantially reduces the number of serologically defined clinical or subclinical infections in infants, children, and adults. These results support the recent World Health Organization recommendations for deployment of typhoid conjugate vaccines in high-burden areas.
METHODS: Data were obtained from a previously published phase 3 randomized controlled trial comparing Vi polysaccharide-tetanus toxoid conjugate vaccine (Vi-TT) with Vi polysaccharide vaccine (Vi-PS) in participants aged 2-45 years. An additional open-label arm administered Vi-TT to children aged 6-23 months. The proportion of participants with presumed clinical or subclinical infection ("seroincidence") was determined using mixture models and compared using relative risks (RRs).
RESULTS: Of 387 participants, 81 (21%) were classified as having presumed typhoid infection during the 2-year postvaccination period. Seroincidence was lower in participants randomized to Vi-TT rather than Vi-PS among those aged 2-45 years (RR, 0.372; 95% confidence interval [CI], .235-.588; P < .001) and those aged 2-15 years (RR, 0.424; 95% CI, .231-.778; P = .004). There was no difference in seroincidence for Vi-TT between those aged 2-45 years and those aged 6-23 months (RR, 1.073; 95% CI, .563-2.046; P = .83). Vaccine seroefficacy was 85% (95% CI, 80%-88%).
CONCLUSION: This is the first field estimate of the seroefficacy of a Vi-TT vaccine and shows that Typbar TCV substantially reduces the number of serologically defined clinical or subclinical infections in infants, children, and adults. These results support the recent World Health Organization recommendations for deployment of typhoid conjugate vaccines in high-burden areas.