TY - JOUR
T1 - Evaluation of Peru-15, a new live oral vaccine for cholera, in volunteers
AU - Sack, David A.
AU - Sack, R. Bradley
AU - Shimko, Janet
AU - Gomes, George
AU - O'Sullivan, Donna
AU - Metcalfe, Karen
AU - Spriggs, Dale
N1 - Funding Information:
Grant support: NIH (RR-00035, General Clinical Research Center—Osler 5—Adult, Johns Hopkins Hospital, Baltimore); Virus Research Institute, Cambridge, Massachusetts.
PY - 1997
Y1 - 1997
N2 - A new live oral cholera vaccine, Peru-15, was studied for safety, immunogenicity, and excretion in 2 groups of healthy volunteers. Twelve inpatient volunteers received freshly harvested vaccine in doses of either 107 or 109 cfu. Subsequently 50 outpatient volunteers received freeze- dried vaccine in doses of 108 or 109 cfu or placebo in a three-cell, double-masked, placebo-controlled trial. The strain was well tolerated at all dose levels, and it stimulated high levels of vibriocidal antibodies in most inpatient volunteers and in all outpatient volunteers. Although antitoxin responses were less frequent and of lower magnitude than the vibriocidal responses, antitoxin responses were seen in >60% of the outpatient volunteers. About 60% of the volunteers excreted the vaccine in their feces; however, fecal excretion did not correlate with serologic responses. It is concluded that Peru-15 is a safe and immunogenic oral vaccine for cholera.
AB - A new live oral cholera vaccine, Peru-15, was studied for safety, immunogenicity, and excretion in 2 groups of healthy volunteers. Twelve inpatient volunteers received freshly harvested vaccine in doses of either 107 or 109 cfu. Subsequently 50 outpatient volunteers received freeze- dried vaccine in doses of 108 or 109 cfu or placebo in a three-cell, double-masked, placebo-controlled trial. The strain was well tolerated at all dose levels, and it stimulated high levels of vibriocidal antibodies in most inpatient volunteers and in all outpatient volunteers. Although antitoxin responses were less frequent and of lower magnitude than the vibriocidal responses, antitoxin responses were seen in >60% of the outpatient volunteers. About 60% of the volunteers excreted the vaccine in their feces; however, fecal excretion did not correlate with serologic responses. It is concluded that Peru-15 is a safe and immunogenic oral vaccine for cholera.
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U2 - 10.1086/514025
DO - 10.1086/514025
M3 - Article
C2 - 9207368
AN - SCOPUS:0030904790
SN - 0022-1899
VL - 176
SP - 201
EP - 205
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 1
ER -