title: Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults.
abstract: 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.
authors.affiliation: National Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
authors.forename: Dang Duc
authors.initials: DD
authors.lastname: Anh
authors.forename: Do Gia
authors.initials: DG
authors.lastname: Canh
authors.forename: Anna Lena
authors.initials: AL
authors.lastname: Lopez
authors.forename: Vu Dinh
authors.initials: VD
authors.lastname: Thiem
authors.forename: Phan Thi
authors.initials: PT
authors.lastname: Long
authors.forename: Nguyen Hong
authors.initials: NH
authors.lastname: Son
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Deen
authors.forename: Lorenz
authors.initials: L
authors.lastname: von Seidlein
authors.forename: Rodney
authors.initials: R
authors.lastname: Carbis
authors.forename: Seung Hyun
authors.initials: SH
authors.lastname: Han
authors.forename: Seong Hye
authors.initials: SH
authors.lastname: Shin
authors.forename: Stephen
authors.initials: S
authors.lastname: Attridge
authors.forename: Jan
authors.initials: J
authors.lastname: Holmgren
authors.forename: John
authors.initials: J
authors.lastname: Clemens
mesh_terms: 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
chemical_list: D022121:Cholera Vaccines; D015164:Vaccines, Inactivated