TY - JOUR
T1 - The design and analysis of cholera vaccine trials
T2 - Recent lessons from bangladesh
AU - Clemens, John
AU - Sack, David
AU - Rao, Malla
AU - Chakraborty, J.
AU - Kay1, Bradford
AU - Ahmed, Faruque
AU - Khan, M. R.
AU - Vanloon1, Fpl
AU - Svennerholm, A. M.
AU - Holmgren, Jan
PY - 1993/8
Y1 - 1993/8
N2 - The recent spread of cholera to Latin America, together with the persistent burden of this disease in Asia and Africa, have stimulated efforts to evaluate new cholera vaccines in field settings. Although the standard experimental paradigm for vaccine field trials is well established, the success of these trials will also depend on suitable consideration of the epidemiology of cholera and of cholera vaccination in the settings under study. Epidemiological studies done in Bangladesh emphasize the importance of appreciating the poorty predictable, multifocal occurrence of cholera in estimating a probable incidence of cholera for a field trial. They also underscore how the filtering effect of enrolling subjects into a prospective trial can dramatically reduce the available population for study, and can yield a study sample whose expected risk of cholera differs markedly from that for the source population. Finally, the data highlight the subtle effects that the mode of surveillance and the choice of an outcome definition can have upon protective efficacy, and emphasize the need for subgroup analyses that address the distinctive variations in vaccine protection that may occur in subjects differing in age and in ABO blood groups, and in subjects exposed to classical versus El Tor cholera.
AB - The recent spread of cholera to Latin America, together with the persistent burden of this disease in Asia and Africa, have stimulated efforts to evaluate new cholera vaccines in field settings. Although the standard experimental paradigm for vaccine field trials is well established, the success of these trials will also depend on suitable consideration of the epidemiology of cholera and of cholera vaccination in the settings under study. Epidemiological studies done in Bangladesh emphasize the importance of appreciating the poorty predictable, multifocal occurrence of cholera in estimating a probable incidence of cholera for a field trial. They also underscore how the filtering effect of enrolling subjects into a prospective trial can dramatically reduce the available population for study, and can yield a study sample whose expected risk of cholera differs markedly from that for the source population. Finally, the data highlight the subtle effects that the mode of surveillance and the choice of an outcome definition can have upon protective efficacy, and emphasize the need for subgroup analyses that address the distinctive variations in vaccine protection that may occur in subjects differing in age and in ABO blood groups, and in subjects exposed to classical versus El Tor cholera.
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U2 - 10.1093/ije/22.4.724
DO - 10.1093/ije/22.4.724
M3 - Article
C2 - 8225749
AN - SCOPUS:0027337566
SN - 0300-5771
VL - 22
SP - 724
EP - 730
JO - International journal of epidemiology
JF - International journal of epidemiology
IS - 4
ER -