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Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a

NCT02646371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-01-27

Study results available
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Summary

In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella flexneri 2a strain compared to subjects receiving placebo.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Flexyn2a

2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart

BIOLOGICAL

Placebo

2 doses of TBS solution will be injected intramuscularly 4 weeks apart

Sponsors & Collaborators

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Kawsar R Talaat, MD · Johns Hopkins Bloomberg School of Public Health

  • Patricia Martin, PhD · LimmaTech Biologics AG

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
2015-12-31
Primary Completion
2016-09-30
Completion
2017-07-31

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 NCT02646371 on ClinicalTrials.gov