Challenge Study of an ETEC Vaccine

NCT01922856 | Completed Phase 2

• 3 other identifiers: S-12-24NMRC.2013.0011CIR 289
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.

Conditions

Enteritis; Escherichia Coli, Enterotoxigenic

Outcome Measures

Primary Outcomes (2)

• Number of adverse events associated with vaccine

  Up to 1 year

• Number of prevented diarrhea episodes

  24 hours

Study Arms (2)

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).

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).

Other: No Intervention

Interventions

LTR192G with dscCfaE BIOLOGICAL

Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G)

Challenge (Vaccinated)

No Intervention OTHER

Controls only receive challenge

Challenge (Unvaccinated)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (2)

Johns Hopkins Center for Immunization Research

Baltimore, Maryland, 21205, United States

Location

Naval Medical Research Center

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Enteritis; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Kawsar Talaat, MD

  Johns Hopkins Center for Immunization Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: September 19, 2013
• Primary Completion: February 6, 2016
• Study Completion: July 14, 2016
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

US (2)