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| Name | Class |
|---|---|
| U.S. Naval Medical Research Unit No. 3 | UNKNOWN |
| Ministry of Health and Population, Egypt | OTHER_GOV |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over a one year period of follow-up by active surveillance. The vaccine consists of a mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is heat-killed Escherichia coli K-12 bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Killed ETEC/rCTB vaccine | Experimental | Three doses administered orally at 2-week intervals |
|
| Placebo | Placebo Comparator | Three doses administered orally at 2-week intervals |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETEC/rCTB vaccine | Biological | Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen. | Time to first event of diarrhea associated with excretion of VP-ETEC (defined as ETEC expressing heat-labile [LT] and heat-stable enterotoxin [ST], or ST and a vaccine-shared colonization factor [i.e., CFA/I, CS1, CS2, CS3, CS4, and/or CS5]) and no other copathogen. | 365-day period starting 14 days after the third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first event of diarrhea due to ST-only ETEC expressing a vaccine-shared CF (ST-VCF-ETEC) as defined below, and no other copathogen.. | Time to first event of diarrhea associated with excretion of ST-VCF-ETEC (defined as ETEC expressing ST-only plus any vaccine-shared colonization factor [i.e., CFA/I, CS1, CS2, CS3, CS4, and/or CS5]) and no other copathogen. | 365-day period starting 14 days after the third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Savarino, MD, MPH | Naval Medical Research Center | Principal Investigator |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| International Vaccine Institute | OTHER |
| Göteborg University | OTHER |
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| Placebo | Other | Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10^11 heat-killed bacteria per dose) |
|
| All events of diarrhea irrespective of etiology | All events (i.e., initial plus recurrent) of diarrhea associated with excretion of any ETEC, irrespective of phenotype, and no other copathogen. | 365-day period starting 14 days after the third vaccination |
| IgG seroconversion | IgG seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and vaccine-specific colonization factors CFA/I, CS2, CS4 | Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose |
| IgA seroconversion | IgA seroconversion (≥ twofold increase in post-vaccination endpoint titer over baseline) against rCTB and selected vaccine-specific colonization factors CFA/I, CS2, CS4 | Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose |
| Number of solicited adverse events | (i.e., diarrhea, vomiting, fever by caregiver report, poor feeding, and irritability) | 3-day period after each dose |