TY - JOUR
T1 - B Subunit-Whole Cell and Whole Cell-Only Oral Vaccines Against Cholera
T2 - Studies on Reactogenicity and Immunogenicity
AU - Clemens, John D.
AU - Stanton, Bonita F.
AU - Chakraborty, J.
AU - Sack, David A.
AU - Khan, M. R.
AU - Huda, S.
AU - Ahmed, F.
AU - Harris, Jeffrey R.
AU - Yunus, M.
AU - Khan, M. U.
AU - Svennerholm, Ann Mari
AU - Jertborn, M.
AU - Holmgren, Jan
N1 - Funding Information:
Received for publication 10 March 1986, and in revised form 11 July 1986. Informed consent was obtained from all participants in this study. This work was supported by funds from the United States Agency for International Development, the government of Japan, the Swedish Agency for Research Cooperation with Developing Countries, and the World Health Organization. We thank M. Ali, A. K. Banik, Shahriar Chowdhury, Joe Gomes, Dr. N. Huda, Abdul Hye, M. Miah, Abdul Malek, N. Noorullah, Anisur Rahman, Faisur Rahman, Siddiqur Rahman, O. G. Siddique, and Dr. K. zaman for technical assistance; Alistair Wiley, WHO Bangladesh, for devising cold-chain procedures; Rita Ramos and Jatindra Nath Sarkar for secretarial assistance; the Institut Merieux, Lyon, France and the National Bacteriology Laboratory, Stockholm, Sweden for preparing vaccines and placebo; Dr. James Kaper, University of Maryland, for providing the original strain of E. coli for placebo; and ACO Ltd., Stockholm, for preparing the bicarbonate-citric acid buffer. Please address requests for reprints to Dr. John D. Clemens, International Centre for Diarrhoeal Disease Research, G.P.O. Box 128, Dhaka 2, Bangladesh.
PY - 1987/1
Y1 - 1987/1
N2 - We conducted a randomized trial among persons in rural Bangladesh to evaluate the side effects and immunogenicity of orally administered B subunit-killed whole cell (BS-WC) and killed whole cell-only (WC) cholera vaccines and a killed Escherichia coli strain K12 placebo proposed for field testing. Three doses of BS-WC, WC, E. coli, or a control agent were given with antacid to 1,257 women (aged b15 years) and children (aged two to 15 years). The four groups exhibited no statistically significant differences in occurrence of symptoms after each dose, and rises in titers of vibriocidal (VC) antibodies to Inaba and Ogawa were twofold higher for vaccinees than for controls (P `.001). Half of the persons with fourfold or greater VC responses to WC responded after the first dose; many additional patients, particularly young children, responded after subsequent doses. In contrast, 89070 of persons who responded to BS-WC with twofold or greater rises in titer of IgG antibodies to cholera toxin did so after the first dose. After the third dose, vaccinees exhibited a fivefold higher rise in titer than did controls (P `.001); a dose-to-dose booster effect was most evident in young children.
AB - We conducted a randomized trial among persons in rural Bangladesh to evaluate the side effects and immunogenicity of orally administered B subunit-killed whole cell (BS-WC) and killed whole cell-only (WC) cholera vaccines and a killed Escherichia coli strain K12 placebo proposed for field testing. Three doses of BS-WC, WC, E. coli, or a control agent were given with antacid to 1,257 women (aged b15 years) and children (aged two to 15 years). The four groups exhibited no statistically significant differences in occurrence of symptoms after each dose, and rises in titers of vibriocidal (VC) antibodies to Inaba and Ogawa were twofold higher for vaccinees than for controls (P `.001). Half of the persons with fourfold or greater VC responses to WC responded after the first dose; many additional patients, particularly young children, responded after subsequent doses. In contrast, 89070 of persons who responded to BS-WC with twofold or greater rises in titer of IgG antibodies to cholera toxin did so after the first dose. After the third dose, vaccinees exhibited a fivefold higher rise in titer than did controls (P `.001); a dose-to-dose booster effect was most evident in young children.
UR - https://www.scopus.com/pages/publications/0023088974
UR - https://www.scopus.com/pages/publications/0023088974#tab=citedBy
U2 - 10.1093/infdis/155.1.79
DO - 10.1093/infdis/155.1.79
M3 - Article
C2 - 3540139
AN - SCOPUS:0023088974
SN - 0022-1899
VL - 155
SP - 79
EP - 85
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 1
ER -