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Field trial of oral cholera vaccines in Bangladesh
Insights
The oral B subunit killed whole-cell (BS-WC) cholera vaccine demonstrated 85% protective efficacy in Bangladeshi children and women. The killed whole-cell (WC) vaccine showed 58% efficacy, highlighting the effectiveness of cholera vaccines.
Area of Science:
- * Infectious Diseases
- * Vaccinology
- * Public Health
Background:
- * Cholera remains a significant public health threat, particularly in regions with limited access to clean water and sanitation.
- * Oral cholera vaccines (OCVs) offer a promising strategy for disease prevention and control.
Purpose of the Study:
- * To evaluate the protective efficacy of two oral cholera vaccines: B subunit killed whole-cell (BS-WC) and killed whole-cell (WC).
- * To assess vaccine performance across different age groups and cholera severities in a high-risk population.
Main Methods:
- * A randomized, double-blind, placebo-controlled trial involving 63,498 participants (children aged 2-15 years and women over 15 years) in Bangladesh.
- * Participants received three doses of either BS-WC, WC, or a placebo.
- * Surveillance for confirmed cholera cases was conducted for six months post-vaccination.
Main Results:
- * The BS-WC vaccine demonstrated a protective efficacy of 85% (p < 0.0001) with only 4 cholera cases observed in the vaccine group compared to 26 in the placebo group.
- * The WC vaccine showed a protective efficacy of 58% (p < 0.01) with 11 cholera cases in the vaccine group.
- * Vaccine efficacy was consistent across different age strata (2-10 years vs. >10 years) and cholera severities.
Conclusions:
- * The oral BS-WC cholera vaccine provides high and statistically significant protection against cholera.
- * The oral WC vaccine also offers significant protection, though to a lesser extent than BS-WC.
- * Both vaccines are effective in diverse age groups and against varying cholera severities, supporting their use in public health interventions.
Abstract:
The protective efficacy of oral B subunit killed whole-cell (BS-WC) and killed whole-cell (WC) cholera vaccines was assessed in 63 498 Bangladeshi children aged 2-15 years and women aged over 15 years. Each received three doses of BS-WC, WC, or placebo in a randomised, double-blinded fashion. Surveillance for cases seeking medical care up to six months after the third dose revealed 26 cases of confirmed cholera in the placebo group, 4 cases in the BS-WC group (protective efficacy 85%; p less than 0.0001), and 11 cases in the WC group (protective efficacy 58%; p less than 0.01). For each vaccine protective efficacy was consistent in different age-groups (2-10 years versus greater than 10 years) and for different severities of cholera.