Safety and immunogenicity in North Americans of a single dose of live oral cholera vaccine CVD 103-HgR: results of a randomized, placebo-controlled, double-blind crossover trial.
We conducted a double-blind, placebo-controlled, randomized crossover study to evaluate the safety and immunogenicity of a single 5 x 10(8)-CFU dose of live oral recombinant cholera vaccine CVD 103-HgR in 94 North American adults. The vaccine was well tolerated without associated adverse reactions. Despite minimal fecal excretion of vaccine, 97% of subjects exhibited serum vibriocidal antibody and 72% had antitoxin responses.
Kotloff
K L
KL
Department of Pediatrics, University of Maryland School of Medicine, Baltimore 21201.
Wasserman
S S
SS
O'Donnell
S
S
Losonsky
G A
GA
Cryz
S J
SJ
Levine
M M
MM
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000032:analysis; D022121:Cholera Vaccines / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012449:Safety; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology*
D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D014614:Vaccines, Synthetic