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| ID | Type | Description | Link |
|---|---|---|---|
| NMRC.2013.0011 | Other Identifier | NMRC IRB | |
| CIR 289 | Other Identifier | CIR |
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The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
The purpose of the study is to establish preliminary efficacy of dscCfaE administered with LTR192G by intradermal (ID) immunization in prevention of disease caused by a challenge with a CFA/I expressing ETEC strain (H10407).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Challenge (Vaccinated) | Experimental | The vaccine will be administered via the ID route to alternating upper arms on days 0, 21, and 42. On the morning of challenge, subjects will drink 120 mL of bicarbonate buffer. Approximately 1 minute later, subjects will drink a solution of virulent H10407 bacteria suspended in the remaining 30 mL of bicarbonate buffer (2 x 10P7P cfu). |
|
| Challenge (Unvaccinated) | Experimental | On the morning of challenge, subjects will drink 120 mL of bicarbonate buffer. Approximately 1 minute later, subjects will drink a solution of virulent H10407 bacteria suspended in the remaining 30 mL of bicarbonate buffer (2 x 10P7P cfu). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTR192G with dscCfaE | Biological | Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events associated with vaccine | Up to 1 year | |
| Number of prevented diarrhea episodes | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
General
Research Related Exclusions Applicable to Vaccination and Challenge Participation
Research Related Exclusions Not Applicable to Challenge-Only Participants
Study-specific Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kawsar Talaat, MD | Johns Hopkins Center for Immunization Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Center for Immunization Research | Baltimore | Maryland | 21205 | United States | ||
| Naval Medical Research Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2020 | |
| Reset | Mar 24, 2020 | |
| Release | Apr 1, 2020 | |
| Reset | Apr 13, 2020 | |
| Release | May 5, 2020 | |
| Reset | May 18, 2020 | |
| Release | Jul 20, 2022 | |
| Reset | Aug 12, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2020 | Mar 24, 2020 | |||
| Apr 1, 2020 |
| ID | Term |
|---|---|
| D004751 | Enteritis |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| No Intervention | Other | Controls only receive challenge |
|
| Silver Spring |
| Maryland |
| 20910 |
| United States |
| Apr 13, 2020 |
| May 5, 2020 | May 18, 2020 |
| Jul 20, 2022 | Aug 12, 2022 |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |