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

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Brief Title

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

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

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Immunogenicity

Secondary Outcome

 Longterm safety and immunogenicity

Condition

Typhoid Fever

Intervention

Ty800 (Salmonella typhi) Oral Vaccine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

180

Start Date

July 2007

Completion Date

June 2008

Primary Completion Date

October 2007

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Clark McKeever, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00498654

Organization ID

Ty800-07-0001



Study Sponsor

Avant Immunotherapeutics


Study Sponsor

Clark McKeever, MD, Principal Investigator, Accelovance LLC


Verification Date

June 2008