Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea

NCT01382095 | Completed Phase 1

• 3 other identifiers: A-16682NMRC.2011.0004WRAIR 1804
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.

Conditions

Escherichia Coli Infection

Keywords

ETEC; Diarrhea; Vaccine

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Adverse event monitoring will survey and specifically inquire about fever (oral temperature \> 100.4 o F), malaise, headache, rash, pain, diarrhea, abdominal pain, extremity pain or swelling. Clinical definitions will be used to grade severity of symptoms in accordance to the severity scale below: Grade 0 = None Grade 1= Barely noticeable Grade 2= Noticeable, does not interfere with daily activities Grade 3=Interferes with daily activities Grade 4=Prevents daily activities

  Days 0 - 180

Secondary Outcomes (3)

• Number of Seroconversion to LT and dscCfaE; defined as a > 4-fold increase in endpoint titer between pre-and post-vaccination samples.

  Study Days 0 - 180

• Number of Mucosal responses (fecal IgA); defined as a > 4-fold increase in endpoint titer after adjusting for total IgA.

  Study Days 0 - 180

• Number of positive IgA-ASC responses; defined as a > 2-fold increase over th e baseline value of the ASC per 10 6 PBMC, when the number of ASC is > 0.5 per 10 6 in the baseline sample

  Study Days 0 - 180

Study Arms (4)

Group A

EXPERIMENTAL

Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G

Group B-1

EXPERIMENTAL

Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G

Group B-2

EXPERIMENTAL

Biological: Recombinant fimbrial adhesin dscCfaE

Group C

EXPERIMENTAL

Biological: Recombinant fimbrial adhesin dscCfaE; Biological: Modified E. coli heat labile enterotoxin LTR192G

Interventions

Recombinant fimbrial adhesin dscCfaE BIOLOGICAL

10 ug on study days 0, 21 and 42

Also known as: dscCfaE

Group A

Modified E. coli heat labile enterotoxin LTR192G BIOLOGICAL

50 ug on study days 0, 21 and 42

Also known as: LTR192G

Group A; Group B-1; Group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 such as, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other conditions that might place the volunteer at increased risk of adverse events. Study clinicians, in consultation with the principal investigator (PI), will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Medical Monitor as appropriate.
• Clinically significant abnormalities on physical examination.
• Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or illness (including IgA deficiency).
• 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.
• Immunosuppressive illness or IgA deficiency (below the normal limits).
• History of chronic skin disease (clinician judgment).
• History of atopy.
• 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.
• History of microbiologically confirmed Enterotoxigenic E. coli (ETEC) or V. cholerae infection.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Walter Reed Army Institute of Research Clinical Trial Center

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Escherichia coli Infections; Diarrhea

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark S. Riddle, MD, DrPH

  Naval Medical Research Center

  PRINCIPAL INVESTIGATOR

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: June 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: April 1, 2013
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

US (1)