Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01382095
• Date of registration: 23/06/2011
• Primary sponsor: U.S. Army Medical Research and Materiel Command
• Public title: Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea
• Scientific title: A Phase 1 Dose-Escalating Study of dscCfaE, Co-Administered With and Without LTR192G, by Transcutaneous Immunization (TCI) in Healthy Adult U.S. Volunteers
• Date of first enrolment: July 2011
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01382095
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Mark S. Riddle, MD, DrPH
• Affiliation: Naval Medical Research Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).

- Exclusionary skin history/findings that would confound assessment or prevent
appropriate local monitoring of adverse events (AEs), or possibly increase the risk
of an AE.

- 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.

- Travel to countries where ETEC or V. cholerae 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. cholerae vaccine or live ETEC or V.
cholerae challenge.

- Occupation involving handling of ETEC or V. cholerae currently, or in the past 3
years.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Escherichia Coli Infection

Intervention(s)

Biological: Modified E. coli heat labile enterotoxin LTR192G

Biological: Recombinant fimbrial adhesin dscCfaE

Primary Outcome(s)

Safety as measured by the presence and severity of local and systemic adverse events following receipt of the investigational products. [Time Frame: Study Days 0 - 180]

Secondary Outcome(s)

Development of systemic and mucosal immune responses as measured by serum and fecal antibody titers to the immunizing antigens as well as vaccine-specific antibody secreting cells. [Time Frame: Study Days 0 - 180]

Secondary ID(s)

A-16682

NMRC.2011.0004

WRAIR 1804

Source(s) of Monetary Support

Please refer to primary and secondary sponsors