Enteritis; Escherichia Coli, EnterotoxigenicPhase 2NCT01922856
Challenge Study of an ETEC Vaccine
A Phase 2 study testing LTR192G with dscCfaE in people with Enteritis; Escherichia Coli, Enterotoxigenic, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial summary
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteritis; Escherichia Coli, Enterotoxigenic
- What is being tested?
- LTR192G with dscCfaE
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2013to 14 Jul 2016
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female age 18 through 50 years (inclusive).
- General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
- Negative pregnancy test. Pregnancy at any time will result in not receiving any or additional investigational product. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children must have this documented (eg, tubal ligation or hysterectomy) or must have negative pregnancy tests.
- Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
- Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of ETEC-associated illness, and by passing a written examination (70% passing score).
- Availability for the study duration, including all planned follow-up visits.
Who cannot join
- General
- Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent.
- Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
- Presence in the serum of HIV antibody, HBsAg, or HCV antibody.
- Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
- Evidence of current excessive alcohol consumption or drug dependence (a targeted drug screen may be used to evaluate at the clinician's discretion).
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- Evidence of impaired immune function.
- Recent vaccination or receipt of an investigational product (within 30 days before vaccination).
- Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study
- Research Related Exclusions Applicable to Vaccination and Challenge Participation
- History of microbiologically confirmed ETEC or cholera infection in last 3 years.
- Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
- Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study.
- Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to dosing.
- Research Related Exclusions Not Applicable to Challenge-Only Participants
- Exclusionary skin history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of an AE.
- History of chronic skin disease (clinician judgment).- History of atopy such as active eczema.
- Acute skin infection/eruptions on the upper arms including fungal infections, severe acne, or active contact dermatitis.
- History of significant allergic reactions to any vaccines and allergies that may increase the risk of AEs (Well-controlled seasonal allergies responsive to antihistamine medication or intranasal steroids are not exclusionary per clinician determination).
- Study-specific Exclusion Criteria
- Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
- Regular use of laxatives, antacids, or other agents to lower stomach acidity.
- Use of any medication known to affect the immune function (eg, systemic corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period.
- Known allergy to two of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Center for Immunization Research
Baltimore, Maryland, 21205
Naval Medical Research Center
Silver Spring, Maryland, 20910
About this study
Official title: A Phase 2b Controlled Efficacy Study of Intradermally Delivered ETEC Fimbrial Tip Adhesin Vaccine Against Experimental Challenge With ETEC H10407 in Healthy Adult Volunteers
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
Read the detailed description
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).
- Being tested
- LTR192G with dscCfaE, No Intervention
- Medical subject headings
- Enteritis, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTR192G with dscCfaEBiological
Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G)
No InterventionOther
Controls only receive challenge
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: LTR192G with dscCfaE |
| 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). Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events associated with vaccine
Measured: Up to 1 year
Number of prevented diarrhea episodes
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start19 Sep 2013
- Primary completion6 Feb 2016
- Study completion14 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteritis; Escherichia Coli, EnterotoxigenicStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kawsar Talaat, MD, Principal investigator, Johns Hopkins Center for Immunization Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922856
- Sponsor's protocol ID
- S-12-24
- Other IDs
- NMRC.2013.0011, CIR 289
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2013
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Controlled Efficacy Study of Intradermally Delivered ETEC Fimbrial Tip Adhesin Vaccine Against Experimental Challenge With ETEC H10407 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01922856
- Acronym / sponsor ID
- S-12-24
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 19 Sep 2013 (actual)
- Primary completion
- 6 Feb 2016 (actual)
- Study completion
- 14 Jul 2016 (actual)
- First posted
- 14 Aug 2013 (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.
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Challenge (Vaccinated) | Experimental | Biological: LTR192G with dscCfaEThe 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 | Other: No InterventionOn 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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female age 18 through 50 years (inclusive).
- General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
- Negative pregnancy test. Pregnancy at any time will result in not receiving any or additional investigational product. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children must have this documented (eg, tubal ligation or hysterectomy) or must have negative pregnancy tests.
- Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
- Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of ETEC-associated illness, and by passing a written examination (70% passing score).
Key exclusion criteria (24 listed)
- General
- Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent.
- Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
- Presence in the serum of HIV antibody, HBsAg, or HCV antibody.
- Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
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 |
|---|---|---|
| LTR192G with dscCfaERecombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G) | Biological | Challenge (Vaccinated) |
| No InterventionControls only receive challenge | Other | Challenge (Unvaccinated) |
Primary outcome
Number of adverse events associated with vaccine
Time frame: Up to 1 year
Number of prevented diarrhea episodes
Time frame: 24 hours
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 6 Jul 2017.
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.
Kawsar Talaat, MD principal investigator
Johns Hopkins Center for Immunization Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LTR192G with dscCfaE in people with Enteritis; Escherichia Coli, Enterotoxigenic, run by U.S. Army Medical Research and Development Command at 2 sites 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 6 inclusion and 24 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of adverse events associated with vaccine (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2017.