TY - JOUR
T1 - Safety and immunogenicity of different immunization regimens of cvd 103-hgr live oral cholera vaccine in soldiers and civilians in thailand
AU - Su-Arehawaratana, Pisit
AU - Singharaj, Preecha
AU - Taylor, David N.
AU - Hoge, Charles
AU - Trofa, Andrew
AU - Kuvanont, Krit
AU - Migasena, Sricharoen
AU - Pitisuttitham, Punnee
AU - Lim, Yu Leung
AU - Losonsky, Genevieve
AU - Kaper, James B.
AU - Wasserman, Steven S.
AU - Cryz, Stanley
AU - Echeverria, Peter
AU - Levine, Myron M.
N1 - Funding Information:
Received 6 November 1991; revised 14 January 1992. The clinical protocol followed the guidelines ofthe Department ofHealth and Human Services and was reviewed by ethical committees at the University ofMaryland at Baltimore. Mahidol University. and the US Department of the Army. The studies were explained in detail, and written informed consent was obtained. Grant support: National Institutes of Health (AI-62528), Swiss Serum and Vaccine Institute, and US Agency for International Development. Reprints or correspondence: Dr. M. M. Levine, Center for Vaccine Development, University of Maryland School of Medicine, 10 S. Pine St., Baltimore, MD 2120 l. * Present affiliation: Department ofBacteriology. Armed Forces Research Institute ofMedical Sciences. Bangkok. Thailand.
Copyright:
Copyright 2016 Elsevier B.V., All rights reserved.
PY - 1992/6
Y1 - 1992/6
N2 - Attenuated Vibrio cholerae oral vaccine CVD 103-HgR was well tolerated by 324 Thai soldiers and civilians. Most received a single 5 × 10(r) cfu dose, while 40 each received one or two 5 × 109cfu doses. Vibriocidal antibody (the best correlate of immunity) seroconversion was lower in soldiers than civilians (P <.001). Increasing the vaccine dose to 5 × 109cfu raised the geometric mean titer (P <.001). A second 5 × 109cfu dose one week later did not notably increase serocon- versions. Likelihood of seroconversion was inversely correlated with baseline vibriocidal titer (P <.001). CVD 103-HgR caused seroconversion in most subjects with baseline titers <1:40, including 100% of civilians after one 5 × 10(r) cfu dose, 79% of soldiers after one 5 × 109cfu dose, and 45% of soldiers after one 5 × 10scfu dose. In persons with elevated baseline titers, vibriocidal antibody seroconversion is not a sensitive measure of whether vaccine has boosted intestinal immunity; for such subjects, other measurements must be used. Study regimens in endemic areas should use a single 5 × 109cfu dose.
AB - Attenuated Vibrio cholerae oral vaccine CVD 103-HgR was well tolerated by 324 Thai soldiers and civilians. Most received a single 5 × 10(r) cfu dose, while 40 each received one or two 5 × 109cfu doses. Vibriocidal antibody (the best correlate of immunity) seroconversion was lower in soldiers than civilians (P <.001). Increasing the vaccine dose to 5 × 109cfu raised the geometric mean titer (P <.001). A second 5 × 109cfu dose one week later did not notably increase serocon- versions. Likelihood of seroconversion was inversely correlated with baseline vibriocidal titer (P <.001). CVD 103-HgR caused seroconversion in most subjects with baseline titers <1:40, including 100% of civilians after one 5 × 10(r) cfu dose, 79% of soldiers after one 5 × 109cfu dose, and 45% of soldiers after one 5 × 10scfu dose. In persons with elevated baseline titers, vibriocidal antibody seroconversion is not a sensitive measure of whether vaccine has boosted intestinal immunity; for such subjects, other measurements must be used. Study regimens in endemic areas should use a single 5 × 109cfu dose.
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U2 - 10.1093/infdis/165.6.1042
DO - 10.1093/infdis/165.6.1042
M3 - Article
C2 - 1583321
AN - SCOPUS:0026596515
VL - 165
SP - 1042
EP - 1048
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - 6
ER -