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Recombinant Attenuated Salmonella Typhi Vaccine Vectors Producing Streptococcus Pneumoniae PspA

NCT01033409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-11-02

No results posted yet for this study

Summary

In this Phase I clinical study, three recombinant, avirulent Salmonella Typhi (RASV) strains each expressing the Streptococcus pneumoniae surface protein, PspA, will be compared as live biological vaccine vectors to evaluate safe and tolerable, single, oral dose levels in adult subjects.

Conditions

Interventions

BIOLOGICAL

Salmonella Typhi-vectored pneumonia vaccine

Liquid, oral dosage administered once at 10\^7 CFU in 10 mL phosphate-buffered saline

BIOLOGICAL

Salmonella Typhi-vectored pneumonia vaccine

Liquid, oral dosage administered once at 10\^8 CFU in 10 mL phosphate-buffered saline

BIOLOGICAL

Salmonella Typhi-vectored pneumonia vaccine

Liquid, oral dosage administered once at 10\^9 CFU in 10 mL phosphate-buffered saline

BIOLOGICAL

Salmonella Typhi-vectored pneumonia vaccine

Liquid, oral dosage administered once at 10\^10 CFU in 10 mL phosphate-buffered saline

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Principal Investigators

  • Sharon Frey, MD · Saint Louis University Center for Vaccine Development, St. Louis, MO USA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033409 on ClinicalTrials.gov