TY - JOUR
T1 - Ty21a live oral typhoid vaccine and prevention of paratyphoid fever caused by Salmonella enterica serovar paratyphi B
AU - Levine, Myron M.
AU - Ferreccio, Catterine
AU - Black, Robert E.
AU - Lagos, Rosanna
AU - San Martin, Oriana
AU - Blackwelder, William C.
N1 - Funding Information:
Supplement sponsorship. This article was published as part of a supplement entitled “Tribute to Ted Woodward,” sponsored by an unrestricted grant from Cubist Pharmaceuticals and a donation from John G. McCormick of McCormick & Company, Hunt Valley, Maryland.
Funding Information:
Financial support. The Area Norte and Area Occidente field trials of Ty21a performed in the 1980s were supported by grants from the World Health Organization, the Pan American Health Organization, and the US Department of Defense (M.M.L. was principal investigator on these grants). R.L. has received research funding from the Ty21A manufacturer, Berna Biotech, for clinical studies with their oral cholera vaccine. No external support supported the recent reanalysis of the pooled data undertaken for this supplement.
PY - 2007/7/15
Y1 - 2007/7/15
N2 - In randomized, controlled field trials in Area Norte and Area Occidente of Santiago, Chile, 2 (Norte) or 3 (Occidente) doses of live oral typhoid vaccine Ty21a in enteric-coated capsules conferred protection against confirmed Salmonella enterica serovar Typhi disease (53% efficacy in Norte; 67% efficacy in Occidente) during 3 years of follow-up. There was also a trend in each trial showing protection against S. enterica serovar Paratyphi B disease (56% efficacy in Norte; 42% efficacy in Occidente). To enhance statistical power, an analysis was performed using pooled data from the 2 trials; this pooling of data was justified by the following facts: epidemiologic surveillance and microbiological methods were identical, the trials overlapped during 22 of the 36 months of follow-up in each trial, the estimates of efficacy against paratyphoid B fever in the 2 trials were roughly similar, and the ratio of follow-up of vaccine recipients to control subjects in both trials was ∼1:1. In the pooled analysis, Ty21a conferred significant protection against paratyphoid B fever (efficacy, 49%; 95% confidence interval, 8%-73%; P = .019).
AB - In randomized, controlled field trials in Area Norte and Area Occidente of Santiago, Chile, 2 (Norte) or 3 (Occidente) doses of live oral typhoid vaccine Ty21a in enteric-coated capsules conferred protection against confirmed Salmonella enterica serovar Typhi disease (53% efficacy in Norte; 67% efficacy in Occidente) during 3 years of follow-up. There was also a trend in each trial showing protection against S. enterica serovar Paratyphi B disease (56% efficacy in Norte; 42% efficacy in Occidente). To enhance statistical power, an analysis was performed using pooled data from the 2 trials; this pooling of data was justified by the following facts: epidemiologic surveillance and microbiological methods were identical, the trials overlapped during 22 of the 36 months of follow-up in each trial, the estimates of efficacy against paratyphoid B fever in the 2 trials were roughly similar, and the ratio of follow-up of vaccine recipients to control subjects in both trials was ∼1:1. In the pooled analysis, Ty21a conferred significant protection against paratyphoid B fever (efficacy, 49%; 95% confidence interval, 8%-73%; P = .019).
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U2 - 10.1086/518141
DO - 10.1086/518141
M3 - Article
C2 - 17582564
AN - SCOPUS:34447130201
SN - 1058-4838
VL - 45
SP - S24-S28
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - SUPPL. 1
ER -