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

Typhoid Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498654
• Other study ID #: Ty800-07-0001
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: June 27, 2008
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Avant Immunotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fever
• Typhoid Fever

Intervention

Biological:
• Ty800 (Salmonella typhi) Oral Vaccine

Locations

Country	Name	City	State
United States	Accelovance LLC	Houston	Texas
United States	Accelovance LLC	Melbourne	Florida
United States	Accelovance LLC	Peoria	Illinois
United States	Accelovance LLC	San Diego	California
United States	Accelovance LLC	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Avant Immunotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity		Baseline through Day 14	No
Primary	Reactogenicity		Baseline through Month 1 follow-up	Yes
Secondary	Longterm safety and immunogenicity		Month 1 to 6 post-dosing	Yes