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Safety and Immunogenicity of CVD 1902 Oral Attenuated Vaccine to Prevent S. Paratyphi A Infection

NCT01129453 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-04-30

No results posted yet for this study

Summary

The purpose of this study is to determine whether CVD 1902 (a live, attenuated, oral vaccine) is safe and effective in the prevention of Salmonella enterica serovar paratyphi A infection.

Conditions

  • Salmonella

Interventions

BIOLOGICAL

CVD 1902, a Salmonella enterica Serovar Paratyphi A live, oral vaccine

CVD 1902 consists of ΔguaBA, ΔclpX Salmonella enterica serovar Paratyphi A vaccine strain diluted in sterile phosphate buffered saline to achieve the desired inoculum. Form: liquid. Dose: 10\^6, 10\^7, 10\^8, or 10\^9 CFU per mL. Route: oral.

OTHER

Placebo

30 ml of buffer solution (2.0 grams of NaHCO3 dissolved in 150 ml of sterile water) without bacteria, to which food grade corn starch, USP is added, as necessary, to match the turbidity of the vaccine inoculum

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Karen L Kotloff, M.D. · University of Maryland, Baltimore Center for Vaccine Development

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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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 NCT01129453 on ClinicalTrials.gov