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Meta-Analysis
. 2024 Jan 10;1(1):CD014573.
doi: 10.1002/14651858.CD014573.

Oral killed cholera vaccines for preventing cholera

K M Saif-Ur-Rahman  1   2   3 , Razib Mamun  4 , Md Hasan  5   6 , James E Meiring  7 , Md Arifuzzaman Khan  8   9
Affiliations
Meta-Analysis

Oral killed cholera vaccines for preventing cholera

K M Saif-Ur-Rahman et al. Cochrane Database Syst Rev. .

Abstract

Background: Cholera causes acute watery diarrhoea and death if not properly treated. Outbreaks occur in areas with poor sanitation, including refugee camps. Several vaccines have been developed and tested over the last 50 years. This is an update of a Cochrane review, originally published in 1998, which explored the effects of all vaccines for preventing cholera. This review examines oral vaccines made from killed bacteria.

Objectives: To assess the effectiveness and safety of the available World Health Organization (WHO)-prequalified oral killed cholera vaccines among children and adults.

Search methods: We searched the Cochrane Infectious Diseases Group Specialized Register; CENTRAL, MEDLINE; Embase; LILACS; and two trials registers (February 2023).

Selection criteria: We included randomized controlled trials (RCTs), including cluster-RCTs. There were no restrictions on the age and sex of the participants or the setting of the study. We considered any available WHO-prequalified oral killed cholera vaccine as an intervention. The control group was given a placebo, another vaccine, or no vaccine. The outcomes were related to vaccine effectiveness and safety. We included articles published in English only.

Data collection and analysis: Two review authors independently applied the inclusion criteria and extracted data from included studies. We assessed the risk of bias using the Cochrane ROB 1 assessment tool. We used the generic inverse variance and a random-effects model meta-analysis to estimate the pooled effect of the interventions. We assessed the certainty of the evidence using the GRADE approach. For vaccine effectiveness (VE), we converted the overall risk ratio (RR) to vaccine effectiveness using the formula: VE = (1 - RR) x 100%.

Main results: Five RCTs, reported in 12 records, with 462,754 participants, met the inclusion criteria. We identified trials on whole-cell plus recombinant vaccine (WC-rBS vaccine (Dukoral)) from Peru and trials on bivalent whole-cell vaccine (BivWC (Shanchol)) vaccine from India and Bangladesh. We did not identify any trials on other BivWC vaccines (Euvichol/Euvichol-Plus), or Hillchol. Two doses of Dukoral with or without a booster dose reduces cases of cholera at two-year follow-up in a general population of children and adults, and at five-month follow-up in an adult male population (overall VE 76%; RR 0.24, 95% confidence interval (CI) 0.08 to 0.65; 2 trials, 16,423 participants; high-certainty evidence). Two doses of Shanchol reduces cases of cholera at one-year follow-up (overall VE 37%; RR 0.63, 95% CI 0.47 to 0.85; 2 trials, 241,631 participants; high-certainty evidence), at two-year follow-up (overall VE 64%; RR 0.36, 95% CI 0.16 to 0.81; 2 trials, 168,540 participants; moderate-certainty evidence), and at five-year follow-up (overall VE 80%; RR 0.20, 95% CI 0.15 to 0.26; 1 trial, 54,519 participants; high-certainty evidence). A single dose of Shanchol reduces cases of cholera at six-month follow-up (overall VE 40%; RR 0.60, 95% CI 0.47 to 0.77; 1 trial, 204,700 participants; high-certainty evidence), and at two-year follow-up (overall VE 39%; RR 0.61, 95% CI 0.53 to 0.70; 1 trial, 204,700 participants; high-certainty evidence). A single dose of Shanchol also reduces cases of severe dehydrating cholera at six-month follow-up (overall VE 63%; RR 0.37, 95% CI 0.28 to 0.50; 1 trial, 204,700 participants; high-certainty evidence), and at two-year follow-up (overall VE 50%; RR 0.50, 95% CI 0.42 to 0.60; 1 trial, 204,700 participants; high-certainty evidence). We found no differences in the reporting of adverse events due to vaccination between the vaccine and control/placebo groups.

Authors' conclusions: Two doses of Dukoral reduces cases of cholera at two-year follow-up. Two doses of Shanchol reduces cases of cholera at five-year follow-up, and a single dose of Shanchol reduces cases of cholera at two-year follow-up. Overall, the vaccines were safe and well-tolerated. We found no trials on other BivWC vaccines (Euvichol/Euvichol-Plus). However, BivWC products (Shanchol, Euvichol/Euvichol-Plus) are considered to produce comparable vibriocidal responses. Therefore, it is reasonable to apply the results from Shanchol trials to the other BivWC products (Euvichol/Euvichol-Plus).

PubMed Disclaimer

Conflict of interest statement

KM Saif‐Ur‐Rahman: none declared

Razib Mamun: none declared

Md Hasan: none declared

James Meiring: none declared

Arifuzzaman Khan is a co‐author in two included articles (Qadri 2015; Qadri 2016). He was not engaged in data extraction or assessment of the risk of bias of the included articles.

Figures

1
1
PRISMA flow diagram
2
2
Summary of risk of bias assessments for each domain.
3
3
Summary of risk of bias as percentages across all studies.
1.1
1.1. Analysis
Comparison 1: WC‐rBS vaccine (Dukoral) versus placebo, Outcome 1: Cases of cholera (2 doses + booster dose; 2‐year follow‐up; per‐protocol analysis)
1.2
1.2. Analysis
Comparison 1: WC‐rBS vaccine (Dukoral) versus placebo, Outcome 2: Cases of cholera (2 doses ± booster dose; 5‐month and 2‐year follow‐up; per‐protocol analysis)
2.1
2.1. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 1: Cases of cholera (2 doses; 1‐year follow‐up; per‐protocol analysis)
2.2
2.2. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 2: Cases of cholera (2 doses; 2‐year follow‐up; per‐protocol analysis)
2.3
2.3. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 3: Cases of cholera (2 doses; 5‐year follow‐up; per‐protocol analysis)
2.4
2.4. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 4: Cases of cholera (1 dose; 6‐month follow‐up; per‐protocol analysis)
2.5
2.5. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 5: Cases of severe dehydrating cholera (1 dose; 6‐month follow‐up; per‐protocol analysis)
2.6
2.6. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 6: Cases of cholera (1 dose; 2‐year follow‐up; per‐protocol analysis)
2.7
2.7. Analysis
Comparison 2: BivWC vaccine (Shanchol) versus placebo, Outcome 7: Cases of severe dehydrating cholera (1 dose; 2‐year follow‐up; per‐protocol analysis)
See this image and copyright information in PMC

References

References to studies included in this review

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