Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults.
Vietnam currently produces an orally administered, bivalent (O1 and O139) killed whole-cell vaccine and is the only country in the world with endemic cholera to use an oral cholera vaccine in public health practice. In order to allow international use, the vaccine had to be reformulated to meet World Health Organization (WHO) requirements. We performed a randomized, placebo controlled, safety and immunogenicity studies of this reformulated vaccine among Vietnamese adults. One hundred and forty-four subjects received the two-dose regimen and 143 had two blood samples obtained for analysis. We found that this reformulated oral killed whole-cell cholera vaccine was safe, well tolerated and highly immunogenic.
Anh
Dang Duc
DD
National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Canh
Do Gia
DG
Lopez
Anna Lena
AL
Thiem
Vu Dinh
VD
Long
Phan Thi
PT
Son
Nguyen Hong
NH
Deen
Jacqueline
J
von Seidlein
Lorenz
L
Carbis
Rodney
R
Han
Seung Hyun
SH
Shin
Seong Hye
SH
Attridge
Stephen
S
Holmgren
Jan
J
Clemens
John
J
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002771:Cholera / Q000276:immunology* / Q000382:microbiology / Q000517:prevention & control; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D041241:Vibrio cholerae O1 / Q000276:immunology*; D041242:Vibrio cholerae O139 / Q000276:immunology*; D014744:Vietnam
D022121:Cholera Vaccines; D015164:Vaccines, Inactivated