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Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children.
Lancet. 1992 Sep 19; 340(8821):689-94.Lct

Abstract

Oral vaccines offer great promise as public-health measures to prevent disease in less-developed countries. CVD 103-HgR, a genetically engineered, attenuated, Vibrio cholerae O1 strain has proved effective in industrialised countries. We have assessed the safety, immunogenicity, and excretion of this live cholera vaccine in children in north Jakarta, Indonesia. 412 children aged 5-9 years received single doses of 5 x 10(6), 5 x 10(7), 5 x 10(8), 5 x 10(9), or 1 x 10(10) colony forming units (CFU) of CVD 103-HgR or placebo (5 x 10(8) inactivated Escherichia coli K-12) with buffer. All doses were well tolerated. The 5 x 10(8) CFU dose, which is highly immunogenic in subjects in industrialised countries (greater than 90% seroconversion), elicited seroconversions of vibriocidal antibody in only 16% of Indonesian children. By contrast, a single 5 x 10(9) CFU dose of vaccine resulted in high rates (75% and 87%) of seroconversion with two different batches of vaccine. A batch prepared with a centrifugation step gave significantly higher geometric mean titres (16-fold increase over baseline) than did a batch in which there was a filtration step between fermentation and lyophilisation (10-fold increase over baseline). At a 5 x 10(9) CFU dose, CVD 103-HgR is well tolerated and highly immunogenic in Indonesian children and should therefore be further investigated for use as a one-dose live oral cholera vaccine in developing countries.

Authors+Show Affiliations

Department of Pediatrics, University of Indonesia, Jakarta.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

1355798

Citation

Suharyono, , et al. "Safety and Immunogenicity of Single-dose Live Oral Cholera Vaccine CVD 103-HgR in 5-9-year-old Indonesian Children." Lancet (London, England), vol. 340, no. 8821, 1992, pp. 689-94.
Suharyono , Simanjuntak C, Witham N, et al. Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children. Lancet. 1992;340(8821):689-94.
Suharyono, ., Simanjuntak, C., Witham, N., Punjabi, N., Heppner, D. G., Losonsky, G., Totosudirjo, H., Rifai, A. R., Clemens, J., & Lim, Y. L. (1992). Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children. Lancet (London, England), 340(8821), 689-94.
Suharyono , et al. Safety and Immunogenicity of Single-dose Live Oral Cholera Vaccine CVD 103-HgR in 5-9-year-old Indonesian Children. Lancet. 1992 Sep 19;340(8821):689-94. PubMed PMID: 1355798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children. A1 - Suharyono,, AU - Simanjuntak,C, AU - Witham,N, AU - Punjabi,N, AU - Heppner,D G, AU - Losonsky,G, AU - Totosudirjo,H, AU - Rifai,A R, AU - Clemens,J, AU - Lim,Y L, PY - 1992/9/19/pubmed PY - 1992/9/19/medline PY - 1992/9/19/entrez KW - Antibodies KW - Antibody Formation KW - Asia KW - Biology KW - Clinical Research KW - Clinical Trials KW - Comparative Studies KW - Developing Countries KW - Diarrhea--prevention and control KW - Diseases KW - Double-blind Studies KW - Immunity KW - Immunologic Factors KW - Indonesia KW - Methodological Studies KW - Physiology KW - Research Methodology KW - Southeastern Asia KW - Studies KW - Vaccines--side effects SP - 689 EP - 94 JF - Lancet (London, England) JO - Lancet VL - 340 IS - 8821 N2 - Oral vaccines offer great promise as public-health measures to prevent disease in less-developed countries. CVD 103-HgR, a genetically engineered, attenuated, Vibrio cholerae O1 strain has proved effective in industrialised countries. We have assessed the safety, immunogenicity, and excretion of this live cholera vaccine in children in north Jakarta, Indonesia. 412 children aged 5-9 years received single doses of 5 x 10(6), 5 x 10(7), 5 x 10(8), 5 x 10(9), or 1 x 10(10) colony forming units (CFU) of CVD 103-HgR or placebo (5 x 10(8) inactivated Escherichia coli K-12) with buffer. All doses were well tolerated. The 5 x 10(8) CFU dose, which is highly immunogenic in subjects in industrialised countries (greater than 90% seroconversion), elicited seroconversions of vibriocidal antibody in only 16% of Indonesian children. By contrast, a single 5 x 10(9) CFU dose of vaccine resulted in high rates (75% and 87%) of seroconversion with two different batches of vaccine. A batch prepared with a centrifugation step gave significantly higher geometric mean titres (16-fold increase over baseline) than did a batch in which there was a filtration step between fermentation and lyophilisation (10-fold increase over baseline). At a 5 x 10(9) CFU dose, CVD 103-HgR is well tolerated and highly immunogenic in Indonesian children and should therefore be further investigated for use as a one-dose live oral cholera vaccine in developing countries. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/1355798/Safety_and_immunogenicity_of_single_dose_live_oral_cholera_vaccine_CVD_103_HgR_in_5_9_year_old_Indonesian_children_ L2 - https://linkinghub.elsevier.com/retrieve/pii/0140-6736(92)92231-4 DB - PRIME DP - Unbound Medicine ER -