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OpenTrials
Completed

NCT Number: NCT00498654

Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of 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.

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Accelovance LLC, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ty800 (Salmonella typhi) Oral Vaccine

Biological

Primary outcomes

  1. Immunogenicity

    Time frame: Baseline through Day 14

  2. Reactogenicity

    Time frame: Baseline through Month 1 follow-up

Secondary outcomes

  1. Longterm safety and immunogenicity

    Time frame: Month 1 to 6 post-dosing

Sponsors and collaborators

Lead sponsor

Avant Immunotherapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jul 10, 2007
Registry last updated
Jul 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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