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Safety and Efficacy of a Typhoid Conjugate Vaccine in Malawian Children.
- Source :
-
The New England journal of medicine [N Engl J Med] 2021 Sep 16; Vol. 385 (12), pp. 1104-1115. - Publication Year :
- 2021
-
Abstract
- Background: Typhoid fever caused by multidrug-resistant H58 Salmonella Typhi is an increasing public health threat in sub-Saharan Africa.<br />Methods: We conducted a phase 3, double-blind trial in Blantyre, Malawi, to assess the efficacy of Vi polysaccharide typhoid conjugate vaccine (Vi-TCV). We randomly assigned children who were between 9 months and 12 years of age, in a 1:1 ratio, to receive a single dose of Vi-TCV or meningococcal capsular group A conjugate (MenA) vaccine. The primary outcome was typhoid fever confirmed by blood culture. We report vaccine efficacy and safety outcomes after 18 to 24 months of follow-up.<br />Results: The intention-to-treat analysis included 28,130 children, of whom 14,069 were assigned to receive Vi-TCV and 14,061 were assigned to receive the MenA vaccine. Blood culture-confirmed typhoid fever occurred in 12 children in the Vi-TCV group (46.9 cases per 100,000 person-years) and in 62 children in the MenA group (243.2 cases per 100,000 person-years). Overall, the efficacy of Vi-TCV was 80.7% (95% confidence interval [CI], 64.2 to 89.6) in the intention-to-treat analysis and 83.7% (95% CI, 68.1 to 91.6) in the per-protocol analysis. In total, 130 serious adverse events occurred in the first 6 months after vaccination (52 in the Vi-TCV group and 78 in the MenA group), including 6 deaths (all in the MenA group). No serious adverse events were considered by the investigators to be related to vaccination.<br />Conclusions: Among Malawian children 9 months to 12 years of age, administration of Vi-TCV resulted in a lower incidence of blood culture-confirmed typhoid fever than the MenA vaccine. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT03299426.).<br /> (Copyright © 2021 Massachusetts Medical Society.)
- Subjects :
- Child
Child, Preschool
Double-Blind Method
Female
Follow-Up Studies
Humans
Incidence
Infant
Intention to Treat Analysis
Malawi
Male
Meningococcal Vaccines adverse effects
Salmonella typhi
Typhoid Fever epidemiology
Vaccines, Conjugate
Polysaccharides, Bacterial adverse effects
Typhoid Fever prevention & control
Typhoid-Paratyphoid Vaccines adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 385
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 34525285
- Full Text :
- https://doi.org/10.1056/NEJMoa2035916