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Analysis of efficacy of CVD 103-HgR live oral cholera vaccine against all-cause travellers' diarrhoea in a randomised, double-blind, placebo-controlled study.
Vaccine. 2005 Oct 17; 23(43):5120-6.V

Abstract

Enterotoxigenic Escherichia coli (ETEC), which produces heat labile toxin (LT) and/or heat stable toxin (ST), is considered to be the most common known cause of travellers' diarrhoea (TD). Owing to the antigenic similarity between cholera toxin and LT, immunization with inactivated oral B-subunit/whole-cell cholera vaccine (BS-WC) offers short term (3 months) but significant (>67%) protection against TD caused by LT-related ETEC. Since it expresses the cholera toxin B (CTB) subunit, the live attenuated oral cholera vaccine strain CVD 103-HgR, may induce similar protection. A trial was performed to determine if CVD 103-HgR live oral cholera vaccine would provide a protective efficacy of at least 50% against TD. In addition, the protective efficacy of the vaccine against TD specifically due to LT-ETEC and LT/ST-ETEC was determined. Volunteers (n=134) travelling to Indonesia, India, Thailand or West-Africa were randomised to receive either a placebo (n=65) or the vaccine (n=69). In the placebo group, 46% reported an episode of diarrhoea, compared to 52% in the vaccine group. No significant group differences were found with regard to incidence, duration or severity of all caused TD or ETEC-associated TD. However, ETEC-associated TD occurred earlier in the placebo group (median 5 days), compared to the vaccine group (median 15 days). In conclusion, CVD 103-HgR live oral cholera vaccine failed to provide a 50% protection against TD. This study does not exclude that the vaccine may offer a short-lived protection against ETEC-associated TD. However, the power of the study was limited by the unexpected low incidence of LT-ETEC-associated diarrhoea (9% of all TD) compared to ST-associated TD (24% of all TD).

Authors+Show Affiliations

Department of Infectious and Tropical Diseases, Leiden University Medical Center, Bld. 1, C5-P, Albinusdreef 2, 2300 Leiden, RC, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15982790

Citation

Leyten, E M S., et al. "Analysis of Efficacy of CVD 103-HgR Live Oral Cholera Vaccine Against All-cause Travellers' Diarrhoea in a Randomised, Double-blind, Placebo-controlled Study." Vaccine, vol. 23, no. 43, 2005, pp. 5120-6.
Leyten EM, Soonawala D, Schultsz C, et al. Analysis of efficacy of CVD 103-HgR live oral cholera vaccine against all-cause travellers' diarrhoea in a randomised, double-blind, placebo-controlled study. Vaccine. 2005;23(43):5120-6.
Leyten, E. M., Soonawala, D., Schultsz, C., Herzog, C., Ligthelm, R. J., Wijnands, S., & Visser, L. G. (2005). Analysis of efficacy of CVD 103-HgR live oral cholera vaccine against all-cause travellers' diarrhoea in a randomised, double-blind, placebo-controlled study. Vaccine, 23(43), 5120-6.
Leyten EM, et al. Analysis of Efficacy of CVD 103-HgR Live Oral Cholera Vaccine Against All-cause Travellers' Diarrhoea in a Randomised, Double-blind, Placebo-controlled Study. Vaccine. 2005 Oct 17;23(43):5120-6. PubMed PMID: 15982790.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Analysis of efficacy of CVD 103-HgR live oral cholera vaccine against all-cause travellers' diarrhoea in a randomised, double-blind, placebo-controlled study. AU - Leyten,E M S, AU - Soonawala,D, AU - Schultsz,C, AU - Herzog,C, AU - Ligthelm,R J, AU - Wijnands,S, AU - Visser,L G, PY - 2003/08/07/received PY - 2005/03/03/revised PY - 2005/03/31/accepted PY - 2005/6/29/pubmed PY - 2005/12/13/medline PY - 2005/6/29/entrez SP - 5120 EP - 6 JF - Vaccine JO - Vaccine VL - 23 IS - 43 N2 - Enterotoxigenic Escherichia coli (ETEC), which produces heat labile toxin (LT) and/or heat stable toxin (ST), is considered to be the most common known cause of travellers' diarrhoea (TD). Owing to the antigenic similarity between cholera toxin and LT, immunization with inactivated oral B-subunit/whole-cell cholera vaccine (BS-WC) offers short term (3 months) but significant (>67%) protection against TD caused by LT-related ETEC. Since it expresses the cholera toxin B (CTB) subunit, the live attenuated oral cholera vaccine strain CVD 103-HgR, may induce similar protection. A trial was performed to determine if CVD 103-HgR live oral cholera vaccine would provide a protective efficacy of at least 50% against TD. In addition, the protective efficacy of the vaccine against TD specifically due to LT-ETEC and LT/ST-ETEC was determined. Volunteers (n=134) travelling to Indonesia, India, Thailand or West-Africa were randomised to receive either a placebo (n=65) or the vaccine (n=69). In the placebo group, 46% reported an episode of diarrhoea, compared to 52% in the vaccine group. No significant group differences were found with regard to incidence, duration or severity of all caused TD or ETEC-associated TD. However, ETEC-associated TD occurred earlier in the placebo group (median 5 days), compared to the vaccine group (median 15 days). In conclusion, CVD 103-HgR live oral cholera vaccine failed to provide a 50% protection against TD. This study does not exclude that the vaccine may offer a short-lived protection against ETEC-associated TD. However, the power of the study was limited by the unexpected low incidence of LT-ETEC-associated diarrhoea (9% of all TD) compared to ST-associated TD (24% of all TD). SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/15982790/Analysis_of_efficacy_of_CVD_103_HgR_live_oral_cholera_vaccine_against_all_cause_travellers'_diarrhoea_in_a_randomised_double_blind_placebo_controlled_study_ DB - PRIME DP - Unbound Medicine ER -