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Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

NCT01585181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-06-27

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

Conditions

  • Cholera

Interventions

BIOLOGICAL

PXVX0200

Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension

BIOLOGICAL

Placebo

Approx 2 grams of lactose reconstituted in water

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-08-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01585181 on ClinicalTrials.gov