DiarrheaPhase 1NCT00844493
Low-dose Challenge Model With Enterotoxigenic E Coli
A Phase 1 study testing E coli strain H10407 and buffer and E coli H10407 and buffer in people with Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most common causes of diarrhea in developing countries and is a common cause of travelers diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- E coli strain H10407 and buffer and E coli H10407 and buffer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 45 years of age, inclusive.
- General good health, as determined by physical exam, laboratory testing, and medical history.
- Laboratory values within acceptable range for complete blood count (CBC), Alanine Aminotransferase (ALT), and serum creatinine as determined by PI.
- Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%)
- Able and willing to sign an informed consent.
- Available to participate for the length of the study.
- Female only: Females of childbearing potential will use an effective method of contraception during the study, including abstinence, hormonal contraception, barrier, implantables or injectables.
Who cannot join
- Presence of a clinically significant medical condition (including but not limited to any chronic illnesses, immunosuppressive illness, cancer, diabetes, gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease)
- Evidence of immunoglobulin A (IgA) deficiency (serum IgA <5 or limit of detection of assay)
- Evidence of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), by medical history or laboratory testing.
- Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to receipt of investigational agent, OR planned travel to endemic countries during the length of the trial.
- History of significant psychiatric illness requiring hospitalization or any suicide attempts within the past 2 years.
- History of significant drug or alcohol abuse requiring hospitalization or rehabilitation within the past 2 years.
Show all 18Show fewer
- Evidence of significant drug abuse, as determined by the Principal Investigator, on toxicity screening.
- Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; loose or liquid stools other than on an occasional basis.
- History of allergic reaction to fluoroquinolones, cotrimoxazole, or ampicillin/penicillin (excluded if allergic to two of three).
- History of diarrhea in the 2 weeks prior to receipt of investigational agent.
- Weekly use of laxatives or any agent that increases gastric pH.
- Use of antibiotics during the 7 days prior to receipt of investigational agent.
- Use of proton pump inhibitors, H2 blockers, or antacids within 48 hours of receipt of investigational agent.
- History of vaccination for or ingestion of ETEC, cholera, or heat labile toxin (LT) toxin within 5 years.*
- History of participation in prior ETEC H10407 research studies.*
- Use of any other investigational product within 30 days preceding the receipt of investigational agent, or planned use during the active study period.
- Use of any medication known to affect the immune function (e.g., corticosteroids) within 30 days preceding receipt of investigational agent or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects).
- Any other condition, which in the opinion of the investigator, could affect subject safety or interfere with the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research, Johns Hopkins Bloomberg School of Public Heatlh
Baltimore, Maryland, 21205
About this study
Official title: Validation of Low-dose ETEC Challenge Model in U.S. Adults and Re-challenge of Immune Subjects With a Homologous ETEC Strain (H10407)
This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most common causes of diarrhea in developing countries and is a common cause of travelers diarrhea. Vaccines are now being developed and their development will be facilitated if we have a valid model for testing these vaccines in human volunteers. We anticipate that the new vaccines will be given to volunteers and they will then be given a dose of virulent ETEC bacteria. If the vaccine is effective, the volunteers should not development diarrhea, but if the vaccine is not effective, the volunteers will have diarrhea for a few days.
During this study, we will validate a minimum dose of virulent ETEC bacteria which is sufficient to cause diarrhea in healthy adult volunteers and to identify conditions that can make this model reliable.
We will also determine, in a follow-up group of volunteers, if being exposed to the ETEC bacteria previously will protect against a subsequent illness when they are exposed to the same bacteria a second time. We believe that the previously exposed group will be protected and we will study the immune response to these exposures to help design vaccines that can accomplish this kind of protection.
Read the detailed description
This is a study in which healthy adult inpatient volunteers will be challenged with Escherichia coli, strain H10407 using different conditions. The study has the following objectives.
- To identify a revised set of procedures for the ETEC H10407 challenge model that will allow for an inoculum dose <108 organisms, and that will cause diarrhea in 50% or more of subjects without causing high output diarrhea, as determined by stool output volumes or signs and symptoms associated with hypovolemia.
- To measure mucosal and systemic immune responses to ETEC H10407 in naïve and immune subjects.
- To determine the extent to which recent enteric illness due to ETEC H10407will protect subjects against diarrhea when re-challenged with H10407.
- To determine the extent to which mucosal and/or systemic antibody responses following ETEC H10407diarrhea are predictive of protection in a re-challenge study.
The study is divided into 4 cohorts. The first cohort will test four conditions of dose and buffer for the challenge. Using the conditions that appear to be best, a larger number of volunteers will be given this challenge to validate these conditions. The third group will be divided between some volunteers who had been ill during previous studies and some who have not been exposed before.
Specimens will be obtained to determine the extent of excretion of the challenge strain and the immune responses to the challenge. These will include measures of both systemic and local intestinal immunity.
Update as of May 2010:
The clinical portion of the study has been completed and is no longer recruiting. The overall results were presented at two meetings including the Vaccines for Enteric Diseases in Spain in 2009 and the US-Japan Medical Science conference on Cholera and Enteric Disease in San Diego in 2009. Volunteers who received the lower dose (7 logs), along with an overnight fast developed diarrhea with an attack rate of >75%. Volunteers who were challenged a second time with this dose were protected from subsequent illness. Immunological assessment of the volunteers is continuing.
Update as of November 2011 Results of the first three cohorts were published in 2011 (see citation below). A fourth cohort is planned to be enrolled to evaluate the virulence of an even lower dose of 5 and 6 logs of E coli. The same procedures will be carried out as with earlier cohorts.
Update as of April 2013 Following challenge with 5 or 6 logs of strain H10407, the attack rates were lower (approximately 30%). Among those volunteers who did develop illness, the severity was the same as with higher doses. completion of these lower doses completes the dose response curve for H10407. For future challenge studies, 7 logs of H10407 with bicarbonate buffer will be used.
- Conditions
- Diarrhea
- Being tested
- E coli strain H10407 and buffer, E coli H10407 and buffer
- Keywords
- diarrhea, vaccine, enterotoxigenic E coli, colonization factor antigen, volunteer study
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E coli strain H10407 and bufferBiological
7 or 8 logs of the bacteria with bicarbonate buffer
E coli strain H10407 and bufferBiological
Bacteria in a dose of 8 logs with CeraVacx buffer
E coli strain H10407 and bufferBiological
Bacteria in a dose of 7 logs and CeraVacx buffer
E coli H10407 and bufferBiological
Bacteria in a dose of 8 logs with bicarbonate buffer
| Study group | Role | What they receive |
|---|---|---|
| H10407 challenge 1 | Experimental | 7 or 8 logs of E. coli strain H10407 with CeraVacx buffer Receives: Biological: E coli strain H10407 and buffer |
| H10407 challenge 2 | Experimental | 7 or 8 logs of E. coli strain H10407 with bicarbonate buffer Receives: Biological: E coli strain H10407 and buffer |
| H10407 challenge 3 | Experimental | 6 logs of E. coli H10407 with bicarbonate buffer Receives: Biological: E coli strain H10407 and buffer |
| H10407 challenge 4 | Experimental | 5 logs of E. coli H10407 with bicarbonate buffer Receives: Biological: E coli H10407 and buffer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of moderate or severe diarrhea
Measured: 5 days
Secondary outcomes (1)
Antibody response to Cholera toxin b subunit, Lipopolysaccharide and colonization factor antigen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- PATH Vaccine Solutions
- Responsible party
- Sponsor
- Investigators
- Clayton Harro, M.D., Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844493
- Sponsor's protocol ID
- CIR259
- Status last verified
- Apr 2013
- First submitted
- 13 Feb 2009
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
McKenzie R, Bourgeois AL, Engstrom F, Hall E, Chang HS, Gomes JG, Kyle JL, Cassels F, Turner AK, Randall R, Darsley M, Lee C, Bedford P, Shimko J, Sack DA. Comparative safety and immunogenicity of two attenuated enterotoxigenic Escherichia coli vaccine strains in healthy adults. Infect Immun. 2006 Feb;74(2):994-1000. doi: 10.1128/IAI.74.2.994-1000.2006.
PubMed 16428745Sack DA, Shimko J, Sack RB, Gomes JG, MacLeod K, O'Sullivan D, Spriggs D. Comparison of alternative buffers for use with a new live oral cholera vaccine, Peru-15, in outpatient volunteers. Infect Immun. 1997 Jun;65(6):2107-11. doi: 10.1128/iai.65.6.2107-2111.1997.
PubMed 9169739DuPont HL, Formal SB, Hornick RB, Snyder MJ, Libonati JP, Sheahan DG, LaBrec EH, Kalas JP. Pathogenesis of Escherichia coli diarrhea. N Engl J Med. 1971 Jul 1;285(1):1-9. doi: 10.1056/NEJM197107012850101. No abstract available.
PubMed 4996788Qadri F, Saha A, Ahmed T, Al Tarique A, Begum YA, Svennerholm AM. Disease burden due to enterotoxigenic Escherichia coli in the first 2 years of life in an urban community in Bangladesh. Infect Immun. 2007 Aug;75(8):3961-8. doi: 10.1128/IAI.00459-07. Epub 2007 Jun 4.
PubMed 17548483Qadri F, Ahmed T, Ahmed F, Begum YA, Sack DA, Svennerholm AM; PTE Study Group. Reduced doses of oral killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine is safe and immunogenic in Bangladeshi infants 6-17 months of age: dosing studies in different age groups. Vaccine. 2006 Mar 6;24(10):1726-33. doi: 10.1016/j.vaccine.2005.08.110. Epub 2005 Oct 10.
PubMed 16257098Qadri F, Svennerholm AM, Faruque AS, Sack RB. Enterotoxigenic Escherichia coli in developing countries: epidemiology, microbiology, clinical features, treatment, and prevention. Clin Microbiol Rev. 2005 Jul;18(3):465-83. doi: 10.1128/CMR.18.3.465-483.2005.
PubMed 16020685Harro C, Chakraborty S, Feller A, DeNearing B, Cage A, Ram M, Lundgren A, Svennerholm AM, Bourgeois AL, Walker RI, Sack DA. Refinement of a human challenge model for evaluation of enterotoxigenic Escherichia coli vaccines. Clin Vaccine Immunol. 2011 Oct;18(10):1719-27. doi: 10.1128/CVI.05194-11. Epub 2011 Aug 18.
PubMed 21852546Chakraborty S, Harro C, DeNearing B, Brubaker J, Connor S, Maier N, Dally L, Flores J, Bourgeois AL, Walker R, Sack DA. Impact of lower challenge doses of enterotoxigenic Escherichia coli on clinical outcome, intestinal colonization and immune responses in adult volunteers. PLoS Negl Trop Dis. 2018 Apr 27;12(4):e0006442. doi: 10.1371/journal.pntd.0006442. eCollection 2018 Apr.
PubMed 29702652
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Low-dose ETEC Challenge Model in U.S. Adults and Re-challenge of Immune Subjects With a Homologous ETEC Strain (H10407)
- ClinicalTrials.gov ID
- NCT00844493
- Acronym / sponsor ID
- CIR259
- Conditions
- Diarrhea
- Keywords
- diarrhea, vaccine, enterotoxigenic E coli, colonization factor antigen, volunteer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- PATH Vaccine Solutions
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will validate a model for testing new vaccines designed to protect against intestinal infections with enterotoxigenic Escherichia coli (ETEC). ETEC is one of the most common causes of diarrhea in developing countries and is a common cause of travelers diarrhea. Vaccines are now being developed and their development will be facilitated if we have a valid model for testing these vaccines in human volunteers. We anticipate that the new vaccines will be given to volunteers and they will then be given a dose of virulent ETEC bacteria. If the vaccine is effective, the volunteers should not development diarrhea, but if the vaccine is not effective, the volunteers will have diarrhea for a few days.
During this study, we will validate a minimum dose of virulent ETEC bacteria which is sufficient to cause diarrhea in healthy adult volunteers and to identify conditions that can make this model reliable.
We will also determine, in a follow-up group of volunteers, if being exposed to the ETEC bacteria previously will protect against a subsequent illness when they are exposed to the same bacteria a second time. We believe that the previously exposed group will be protected and we will study the immune response to these exposures to help design vaccines that can accomplish this kind of protection.
Detailed description
This is a study in which healthy adult inpatient volunteers will be challenged with Escherichia coli, strain H10407 using different conditions. The study has the following objectives.
- To identify a revised set of procedures for the ETEC H10407 challenge model that will allow for an inoculum dose <108 organisms, and that will cause diarrhea in 50% or more of subjects without causing high output diarrhea, as determined by stool output volumes or signs and symptoms associated with hypovolemia.
- To measure mucosal and systemic immune responses to ETEC H10407 in naïve and immune subjects.
- To determine the extent to which recent enteric illness due to ETEC H10407will protect subjects against diarrhea when re-challenged with H10407.
- To determine the extent to which mucosal and/or systemic antibody responses following ETEC H10407diarrhea are predictive of protection in a re-challenge study.
The study is divided into 4 cohorts. The first cohort will test four conditions of dose and buffer for the challenge. Using the conditions that appear to be best, a larger number of volunteers will be given this challenge to validate these conditions. The third group will be divided between some volunteers who had been ill during previous studies and some who have not been exposed before.
Specimens will be obtained to determine the extent of excretion of the challenge strain and the immune responses to the challenge. These will include measures of both systemic and local intestinal immunity.
Update as of May 2010:
The clinical portion of the study has been completed and is no longer recruiting. The overall results were presented at two meetings including the Vaccines for Enteric Diseases in Spain in 2009 and the US-Japan Medical Science conference on Cholera and Enteric Disease in San Diego in 2009. Volunteers who received the lower dose (7 logs), along with an overnight fast developed diarrhea with an attack rate of >75%. Volunteers who were challenged a second time with this dose were protected from subsequent illness. Immunological assessment of the volunteers is continuing.
Update as of November 2011 Results of the first three cohorts were published in 2011 (see citation below). A fourth cohort is planned to be enrolled to evaluate the virulence of an even lower dose of 5 and 6 logs of E coli. The same procedures will be carried out as with earlier cohorts.
Update as of April 2013 Following challenge with 5 or 6 logs of strain H10407, the attack rates were lower (approximately 30%). Among those volunteers who did develop illness, the severity was the same as with higher doses. completion of these lower doses completes the dose response curve for H10407. For future challenge studies, 7 logs of H10407 with bicarbonate buffer will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H10407 challenge 1 | Experimental | Biological: E coli strain H10407 and buffer7 or 8 logs of E. coli strain H10407 with CeraVacx buffer |
| H10407 challenge 2 | Experimental | Biological: E coli strain H10407 and buffer7 or 8 logs of E. coli strain H10407 with bicarbonate buffer |
| H10407 challenge 3 | Experimental | Biological: E coli strain H10407 and buffer6 logs of E. coli H10407 with bicarbonate buffer |
| H10407 challenge 4 | Experimental | Biological: E coli H10407 and buffer5 logs of E. coli H10407 with bicarbonate buffer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 45 years of age, inclusive.
- General good health, as determined by physical exam, laboratory testing, and medical history.
- Laboratory values within acceptable range for complete blood count (CBC), Alanine Aminotransferase (ALT), and serum creatinine as determined by PI.
- Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%)
- Able and willing to sign an informed consent.
Key exclusion criteria (18 listed)
- Presence of a clinically significant medical condition (including but not limited to any chronic illnesses, immunosuppressive illness, cancer, diabetes, gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease)
- Evidence of immunoglobulin A (IgA) deficiency (serum IgA <5 or limit of detection of assay)
- Evidence of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), by medical history or laboratory testing.
- Symptoms consistent with Traveler's Diarrhea concurrent with travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to receipt of investigational agent, OR planned travel to endemic countries during the length of the trial.
- History of significant psychiatric illness requiring hospitalization or any suicide attempts within the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E coli strain H10407 and buffer7 or 8 logs of the bacteria with bicarbonate buffer | Biological | H10407 challenge 1 |
| E coli strain H10407 and bufferBacteria in a dose of 8 logs with CeraVacx buffer | Biological | H10407 challenge 2 |
| E coli strain H10407 and bufferBacteria in a dose of 7 logs and CeraVacx buffer | Biological | H10407 challenge 3 |
| E coli H10407 and bufferBacteria in a dose of 8 logs with bicarbonate buffer | Biological | H10407 challenge 4 |
Primary outcome
Occurrence of moderate or severe diarrhea
Time frame: 5 days
1 secondary outcome
Antibody response to Cholera toxin b subunit, Lipopolysaccharide and colonization factor antigen
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Background: PubMed 16428745McKenzie R, Bourgeois AL, Engstrom F, Hall E, Chang HS, Gomes JG, Kyle JL, Cassels F, Turner AK, Randall R, Darsley M, Lee C, Bedford P, Shimko J, Sack DA. Comparative safety and immunogenicity of two attenuated enterotoxigenic Escherichia coli vaccine strains in healthy adults. Infect Immun. 2006 Feb;74(2):994-1000. doi: 10.1128/IAI.74.2.994-1000.2006.
- Background: PubMed 9169739Sack DA, Shimko J, Sack RB, Gomes JG, MacLeod K, O'Sullivan D, Spriggs D. Comparison of alternative buffers for use with a new live oral cholera vaccine, Peru-15, in outpatient volunteers. Infect Immun. 1997 Jun;65(6):2107-11. doi: 10.1128/iai.65.6.2107-2111.1997.
- Background: PubMed 4996788DuPont HL, Formal SB, Hornick RB, Snyder MJ, Libonati JP, Sheahan DG, LaBrec EH, Kalas JP. Pathogenesis of Escherichia coli diarrhea. N Engl J Med. 1971 Jul 1;285(1):1-9. doi: 10.1056/NEJM197107012850101. No abstract available.
- Background: PubMed 17548483Qadri F, Saha A, Ahmed T, Al Tarique A, Begum YA, Svennerholm AM. Disease burden due to enterotoxigenic Escherichia coli in the first 2 years of life in an urban community in Bangladesh. Infect Immun. 2007 Aug;75(8):3961-8. doi: 10.1128/IAI.00459-07. Epub 2007 Jun 4.
- Background: PubMed 16257098Qadri F, Ahmed T, Ahmed F, Begum YA, Sack DA, Svennerholm AM; PTE Study Group. Reduced doses of oral killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine is safe and immunogenic in Bangladeshi infants 6-17 months of age: dosing studies in different age groups. Vaccine. 2006 Mar 6;24(10):1726-33. doi: 10.1016/j.vaccine.2005.08.110. Epub 2005 Oct 10.
- Background: PubMed 16020685Qadri F, Svennerholm AM, Faruque AS, Sack RB. Enterotoxigenic Escherichia coli in developing countries: epidemiology, microbiology, clinical features, treatment, and prevention. Clin Microbiol Rev. 2005 Jul;18(3):465-83. doi: 10.1128/CMR.18.3.465-483.2005.
- Results publication: PubMed 21852546Harro C, Chakraborty S, Feller A, DeNearing B, Cage A, Ram M, Lundgren A, Svennerholm AM, Bourgeois AL, Walker RI, Sack DA. Refinement of a human challenge model for evaluation of enterotoxigenic Escherichia coli vaccines. Clin Vaccine Immunol. 2011 Oct;18(10):1719-27. doi: 10.1128/CVI.05194-11. Epub 2011 Aug 18.
- Derived from this study: PubMed 29702652Chakraborty S, Harro C, DeNearing B, Brubaker J, Connor S, Maier N, Dally L, Flores J, Bourgeois AL, Walker R, Sack DA. Impact of lower challenge doses of enterotoxigenic Escherichia coli on clinical outcome, intestinal colonization and immune responses in adult volunteers. PLoS Negl Trop Dis. 2018 Apr 27;12(4):e0006442. doi: 10.1371/journal.pntd.0006442. eCollection 2018 Apr.
- resource for vaccines for Enterotoxigenic E coliLink provided by the sponsor.
- web site for the International Centre for Diarrhoeal Disease Research, Bangladesh where much of the work on ETEC is doneLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayton Harro, M.D. principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E coli strain H10407 and buffer and E coli H10407 and buffer in people with Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of moderate or severe diarrhea (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00844493, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.