Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

June 27, 2008 updated by: Avant Immunotherapeutics

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects

The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.

Study Overview

Status

Completed

Conditions

Typhoid Fever

Intervention / Treatment

Biological: Ty800 (Salmonella typhi) Oral Vaccine

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92108
    - Accelovance LLC
- Florida
  - Melbourne, Florida, United States, 32935
    - Accelovance LLC
- Illinois
  - Peoria, Illinois, United States, 61602
    - Accelovance LLC
- Indiana
  - South Bend, Indiana, United States, 46601
    - Accelovance LLC
- Texas
  - Houston, Texas, United States, 77024
    - Accelovance LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy Males or Females aged 18 to 55 years, inclusive
Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion Criteria:

History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immunogenicity Time Frame: Baseline through Day 14	Baseline through Day 14
Reactogenicity Time Frame: Baseline through Month 1 follow-up	Baseline through Month 1 follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Longterm safety and immunogenicity Time Frame: Month 1 to 6 post-dosing	Month 1 to 6 post-dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avant Immunotherapeutics

Investigators

Principal Investigator: Clark McKeever, MD, Accelovance LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria