Table 1.
Clemens et al27 | Taylor et al28 | Sur et al30 | Trach et al29 | ||
---|---|---|---|---|---|
Used whole cell vaccines and dosage; availability | WC-BS (3 doses, 6 weeks apart);* not yet available | WC-rBS (2 doses, 2 weeks apart + booster at 10 months); available | BivWC (2 doses, 2 weeks apart); available | vWC (2 doses, 2 weeks apart); not yet available | |
Study design | Randomized, double blind trial | Randomized, double blind trial | Randomized, double blind trial | Nonrandomized, open label trial | |
Intervention for control group | Heat killed E. coli K12 placebo | Heat killed E. coli K12 placebo | Heat killed E. coli K12 placebo | Heat killed E. coli K12 placebo | |
Setting, study population | Bangladesh, children aged 2–15 years and women over the age of 15 years | Peru, residents aged 2 years or more and less than 66 years | India, children aged more than 1 year and adults (non-pregnant) | Vietnam, residents aged 1 year or more | |
Population (N) [Children (n)] | 62,285 [38,617] | 8089 [14,997] | 66,900 [19,073] | 134,453 [30,414] | |
Efficacy outcomes |
|
|
|
|
|
First year: vaccine efficacy (95% CI) | Overall | 62% (46%–74%) | −4% (−88%–43%) | 45% (−5%–NA) | 66% (46%–79%) |
Children ≤ 5 years old | 38% (−1%–62%) | −291% (−339%–56%) | NA | 69% (16%–88%) | |
Children > 5 years old | 78% (61%–87%) | 16% (−77%–60%) | NA | 64% (42%–78%) | |
Second year: vaccine efficacy (95% CI) | Overall | 58% (40%–71%) | 60% (28%–79%) | 77% (55%–NA) | NA |
Children ≤ 5 years old | 47% (4%–71%) | 52% (−162%–91%) | 41% (−13%–69%) | NA | |
Children > 5 years old | 63% (41%–77%) | 62% (23%–81%) | 72% (49%–84%) | NA |
Notes:
The killed whole cell only group was not considered in this review.
Abbreviations: WC-BS, whole cell plus B subunit vaccine; WC-rBS, whole cell plus recombinant B subunit vaccine; BivWC, bivalent whole cell vaccine; vWC, variant whole cell vaccine; NA, data not available; CI, confidence interval; E. coli, Escherichia coli.