Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults

被引：79

作者：

Anh, Dang Duc

Canh, Do Gia

Lopez, Anna Lena

Thiem, Vu Dinh

Long, Phan Thi

Son, Nguyen Hong

Deen, Jacqueline

von Seidlein, Lorenz

Carbis, Rodney

Han, Seung Hyun

Shin, Seong Hye

Attridge, Stephen

Holmgren, Jan

Clemens, John

机构：

[1] Int Vaccine Inst, Seoul 151818, South Korea

[2] Natl Inst Hyg & Epidemiol, Hanoi, Vietnam

[3] Prov Prevent Med Ctr Son La, Son La, Vietnam

[4] Gothenburg Univ, Gothenburg, Sweden

来源：

VACCINE | 2007年 / 25卷 / 06期

关键词：

cholera vaccine; safety; immunogenicity;

D O I：

10.1016/j.vaccine.2006.09.049

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 :hat this reformulated oral killed whole-cell cholera vaccine was safe, well tolerated and highly immunogenic. (c) 2006 Elsevier Ltd. All rights reserved.

引用

收藏

页码：1149 / 1155

页数：7

相关论文

共 17 条

[1] Susceptibility of Vibrio cholerae O139 to antibody-dependent, complement-mediated bacteriolysis [J].

Attridge, SR ;

Qadri, F ;

Albert, MJ ;

Manning, PA .

CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 2000, 7 (03) :444-450

[2] Sensitive microplate assay for detection of bactericidal antibodies to Vibrio cholerae O139 [J].

Attridge, SR ;

Johansson, C ;

Trach, DD ;

Qadri, F ;

Svennerholm, AM .

CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 2002, 9 (02) :383-387

[3] B-SUBUNIT-WHOLE CELL AND WHOLE CELL-ONLY ORAL VACCINES AGAINST CHOLERA - STUDIES ON REACTOGENICITY AND IMMUNOGENICITY [J].

CLEMENS, JD ;

STANTON, BF ;

CHAKRABORTY, J ;

SACK, DA ;

KHAN, MR ;

HUDA, S ;

AHMED, F ;

HARRIS, JR ;

YUNUS, M ;

KHAN, MU ;

SVENNERHOLM, AM ;

JERTBORN, M ;

HOLMGREN, J .

JOURNAL OF INFECTIOUS DISEASES, 1987, 155 (01) :79-85

[4] SIGNIFICANCE TESTING TO ESTABLISH EQUIVALENCE BETWEEN TREATMENTS, WITH SPECIAL REFERENCE TO DATA IN FORM OF 2 X 2 TABLES [J].

DUNNETT, CW ;

GENT, M .

BIOMETRICS, 1977, 33 (04) :593-602

[5] SAFETY, IMMUNOGENICITY, AND EXCRETION PATTERN OF SINGLE-DOSE LIVE ORAL CHOLERA VACCINE CVD 103-HGR IN PERUVIAN ADULTS OF HIGH AND LOW SOCIOECONOMIC LEVELS [J].

GOTUZZO, E ;

BUTRON, B ;

SEAS, C ;

PENNY, M ;

RUIZ, R ;

LOSONSKY, G ;

LANATA, CF ;

WASSERMAN, SS ;

SALAZAR, E ;

KAPER, JB ;

CRYZ, S ;

LEVINE, MM .

INFECTION AND IMMUNITY, 1993, 61 (09) :3994-3997

[6] SALIVA, BREAST-MILK, AND SERUM ANTIBODY-RESPONSES AS INDIRECT MEASURES OF INTESTINAL IMMUNITY AFTER ORAL CHOLERA VACCINATION OR NATURAL DISEASE [J].

JERTBORN, M ;

SVENNERHOLM, AM ;

HOLMGREN, J .

JOURNAL OF CLINICAL MICROBIOLOGY, 1986, 24 (02) :203-209

[7] Intestinal and systemic immune responses in humans after oral immunization with a bivalent B subunit-O1/O139 whole cell cholera vaccine [J].

Jertborn, M ;

Svennerholm, AM ;

Holmgren, J .

VACCINE, 1996, 14 (15) :1459-1465

[8] Vibriocidal antibody responses in North American volunteers exposed to wild-type or vaccine Vibrio cholerae O139: Specificity and relevance to immunity [J].

Losonsky, GA ;

Lim, Y ;

Motamedi, P ;

Comstock, LE ;

Johnson, JA ;

Morris, JG ;

Tacket, CO ;

Kaper, JB ;

Levine, MM .

CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 1997, 4 (03) :264-269

[9] CLINICAL AND IMMUNOLOGICAL CHARACTERISTICS OF VIBRIO-CHOLERAE O139 BENGAL INFECTION IN NORTH-AMERICAN VOLUNTEERS [J].

MORRIS, JG ;

LOSONSKY, GE ;

JOHNSON, JA ;

TACKET, CO ;

NATARO, JP ;

PANIGRAHI, P ;

LEVIN, MM .

JOURNAL OF INFECTIOUS DISEASES, 1995, 171 (04) :903-908

[10] COMPARISON OF THE VIBRIOCIDAL ANTIBODY-RESPONSE IN CHOLERA DUE TO VIBRIO-CHOLERAE-O139 BENGAL WITH THE RESPONSE IN CHOLERA DUE TO VIBRIO-CHOLERAE-O1 [J].

QADRI, F ;

MOHI, G ;

HOSSAIN, J ;

AZIM, T ;

KHAN, AM ;

SALAM, MA ;

SACK, RB ;

ALBERT, MJ ;

SVENNERHOLM, AM .

CLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, 1995, 2 (06) :685-688