Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
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
3 other identifiers
interventional
57
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 8, 2019
CompletedFebruary 12, 2021
February 1, 2021
1.8 years
July 11, 2012
November 30, 2016
February 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety - Occurrence of Adverse Events
Occurrence of related and unrelated to vaccine AE's
1 year
Secondary Outcomes (2)
Number of Participants With Immune Responses to Vaccine Antigens
baseline and post dose
Antigen-Specific IgA Geometric Mean Titers
Day 0, 21,42, 56, 70
Study Arms (9)
Group A-1
EXPERIMENTALRecombinant fimbrial adhesin dscCfaE: 1 ug of dscCfaE ID on study days 0, 21 and 42
Group A-2
EXPERIMENTALRecombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5: 2.6 ug of Chimera ID on study days 0, 21 and 42
Group A-3
EXPERIMENTALModified E. coli heat labile enterotoxin LTR192G: 100 ng of LTR192G ID on study days 0, 21 and 42
Group B-1
EXPERIMENTALRecombinant 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
EXPERIMENTALRecombinant 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
EXPERIMENTALRecombinant 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
EXPERIMENTALRecombinant 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
EXPERIMENTALRecombinant 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
EXPERIMENTALRecombinant 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Clinically significant abnormalities on basic laboratory screening.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed Army Institute of Research Clinical trial Center
Silver Spring, Maryland, 20910, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ramiro L. Gutierrez, MD, MPH
- Organization
- Enteric Diseases Department, Naval Medical Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ramiro L. Gutierrez, MD, MPH
Enteric Diseases Department, Naval Medical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2012
First Posted
July 19, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2015
Last Updated
February 12, 2021
Results First Posted
July 8, 2019
Record last verified: 2021-02