Escherichia Coli InfectionPhase 1NCT01644565

Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea

A Phase 1 study testing Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G in people with Escherichia Coli Infection, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Escherichia Coli Infection
What is being tested?: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Jun 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
Completion and review of comprehension test (achieved > 70% accuracy).
Signed informed consent document.
Available for the required follow-up period and scheduled clinic visits.
Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following study completion.

Who cannot join

Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the subjects at increased risk of adverse events. Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
Clinically significant abnormalities on physical examination.
Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including IgA deficiency (defined by serum IgA below the detectable limit).
Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last study safety visit and currently nursing women.
Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit.
Positive blood test for HBsAg, HCV, HIV-1.

Show all 19Show fewer

Clinically significant abnormalities on basic laboratory screening.
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.
Allergies that may increase the risk of AEs.
Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy.
Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis.
Prior exposure to ETEC or Vibrio cholera.
History of microbiologically confirmed ETEC or cholera infection.
Travel to countries where ETEC or V. cholera or other enteric infections are endemic (most of the developing world) within two years prior to dosing clinician judgment).
Received previous experimental ETEC or V. cholera vaccine or live ETEC or V. cholera challenge.
Occupation involving handling of ETEC or V. cholera currently, or in the past 3 years.

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed Army Institute of Research Clinical trial Center
Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalating Study of Two Enterotoxigenic Escherichia Coli Prototype Adhesin-based Vaccines With or Without Modified Heat-labile Enterotoxin by Intradermal or Transcutaneous Immunization

The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.

Read the detailed description

The purpose of the study is to evaluate the safety and immunogenicity of dsc14cfaEsCTA2/LTB5 (Chimera) and dscCfaE administered with and without LTR192G by intradermal (ID) immunization and to gather additional data on the administration of dsCfaE and LTR192G via transcutaneous immunization (TCI) route. If vaccines are found to be safe and adequately immunogenic in humans, a down-selection would occur and a phase 2b vaccination/challenge study would be undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy of one of these candidates by the ID or TCI route. With favorable evidence for safety, immunogenicity, efficacy, complemented by advances in standard methodology to combine multiple adhesins with an appropriate LT enterotoxoid form, a multivalent vaccine would be constructed and evaluated for further clinical development.

Conditions: Escherichia Coli Infection
Being tested: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE, Modified E. coli heat labile enterotoxin LTR192G
Medical subject headings: Escherichia coli Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5Biological
Also called Chimera
Recombinant fimbrial adhesin dscCfaEBiological
Also called dscCfaE
Modified E. coli heat labile enterotoxin LTR192GBiological
Also called LTR192G

Study groups in NCT01644565
Study group	Role	What they receive
Group A-1	Experimental	Recombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dscCfaE
Group A-2	Experimental	Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
Group A-3	Experimental	Modified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42 Receives: Biological: Modified E. coli heat labile enterotoxin LTR192G
Group B-1	Experimental	Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G
Group B-2	Experimental	Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5; Biological: Modified E. coli heat labile enterotoxin LTR192G
Group C-1	Experimental	Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G
Group C-2	Experimental	Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5; Biological: Modified E. coli heat labile enterotoxin LTR192G
Group D-1	Experimental	Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G
Group D-2	Experimental	Recombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1250 ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42 Receives: Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety - Occurrence of Adverse Events
Occurrence of related and unrelated to vaccine AE's
Measured: 1 year

Secondary outcomes (2)

Number of Participants With Immune Responses to Vaccine Antigens
Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a > 2-fold increase over the baseline value of the ASC per 10^6 PBMC, when the number of ASC was >0.5 per 10^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10^6 PBMC.
Measured: baseline and post dose
Antigen-Specific IgA Geometric Mean Titers
Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR.
Measured: Day 0, 21,42, 56, 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jun 2015

First posted19 Jul 2012 (estimated)
Study startAug 2012
Primary completionJun 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Escherichia Coli InfectionStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01644565
Sponsor's protocol ID: S-12-07
Other IDs: S-12-07, NMRC.2012.0005, 1924
Status last verified: Feb 2021
First submitted: 11 Jul 2012
Last updated: 12 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Escherichia Coli Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Dose Escalating Study of Two Enterotoxigenic Escherichia Coli Prototype Adhesin-based Vaccines With or Without Modified Heat-labile Enterotoxin by Intradermal or Transcutaneous Immunization
ClinicalTrials.gov ID: NCT01644565
Acronym / sponsor ID: S-12-07
Conditions: Escherichia Coli Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Study start: Aug 2012 (actual)
Primary completion: Jun 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 19 Jul 2012 (estimated)
Results: Posted 8 Jul 2019

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 if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Group A-1	Experimental	Biological: Recombinant fimbrial adhesin dscCfaERecombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Group A-2	Experimental	Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Group A-3	Experimental	Biological: Modified E. coli heat labile enterotoxin LTR192GModified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Group B-1	Experimental	Biological: Recombinant fimbrial adhesin dscCfaE, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Group B-2	Experimental	Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 2.6 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Group C-1	Experimental	Biological: Recombinant fimbrial adhesin dscCfaE, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 5 ug of dscCfaE + 100 ng of LTR192G ID on study days 0, 21 and 42
Group C-2	Experimental	Biological: Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 and Modified E. coli heat labile enterotoxin LTR192G: 12.9 ug of Chimera + 100 ng of LTR192G ID on study days 0, 21 and 42
Group D-1	Experimental	Biological: Recombinant fimbrial adhesin dscCfaE, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 25 ug dscCfaE + 100 ng LTR192G ID on study days 0, 21 and 42
Group D-2	Experimental	Biological: Recombinant fimbrial adhesin dscCfaE, Biological: Modified E. coli heat labile enterotoxin LTR192GRecombinant fimbrial adhesin dscCfaE and Modified E. coli heat labile enterotoxin LTR192G: 1250 ug dscCfaE + 50 ng LTR192G TCI on study days 0, 21 and 42

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
Completion and review of comprehension test (achieved > 70% accuracy).
Signed informed consent document.
Available for the required follow-up period and scheduled clinic visits.
Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following study completion.

Key exclusion criteria (19 listed)

Health problems (for example, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the subjects at increased risk of adverse events. Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
Clinically significant abnormalities on physical examination.
Use of immunosuppressive medications (systemic corticosteroids or chemotherapeutics that may influence antibody development), or immunosuppressive illness, including IgA deficiency (defined by serum IgA below the detectable limit).
Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last study safety visit and currently nursing women.
Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit.

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
Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5Also: Chimera	Biological	Group A-2, Group B-2, Group C-2
Recombinant fimbrial adhesin dscCfaEAlso: dscCfaE	Biological	Group A-1, Group B-1, Group C-1, Group D-1, Group D-2
Modified E. coli heat labile enterotoxin LTR192GAlso: LTR192G	Biological	Group A-3, Group B-1, Group B-2, Group C-1, Group C-2, Group D-1, Group D-2

Primary outcome

Safety - Occurrence of Adverse Events
Time frame: 1 year
Occurrence of related and unrelated to vaccine AE's

2 secondary outcomes

Number of Participants With Immune Responses to Vaccine Antigens
Time frame: baseline and post dose
Antigen-Specific IgA Geometric Mean Titers
Time frame: Day 0, 21,42, 56, 70

Results and safety

Results posted to the registry on 8 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A-1	5	4
Group A-2	5	5
Group A-3	5	5
Group B-1	5	4
Group B-2	5	4
Group C-1	7	7
Group C-2	7	7
Group D-1	10	8
Group D-2	8	7

Primary outcome: Safety - Occurrence of Adverse Events

Time frame: 1 year. Number. Unit: Number of Adverse Events

Measure	Group A-1 n = 4	Group A-2 n = 5	Group A-3 n = 5	Group B-1 n = 4	Group B-2 n = 4	Group C-1 n = 7	Group C-2 n = 7	Group D-1 n = 8	Group D-2 n = 7
Related to Vaccine	7	21	19	20	18	23	25	38	25
Unrelated to Vaccine	17	14	16	14	10	20	8	20	26

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A-1	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Group A-2	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Group A-3	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Group B-1	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Group B-2	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Group C-1	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Group C-2	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Group D-1	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Group D-2	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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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.

Ramiro L. Gutierrez, MD, MPH principal investigator

Enteric Diseases Department, Naval Medical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 19 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 Feb 2021. 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?

Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety - Occurrence of Adverse Events (time frame: 1 year). 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 NCT01644565.

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 Feb 2021.