MedTrace Logo

Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a

NCT02388009 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-12-22

No results posted yet for this study

Summary

This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.

30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Flexyn2a

Intramuscular doses of 0.5 mL

BIOLOGICAL

Placebo

Intramuscular doses of 0.5 mL

BIOLOGICAL

Flexyn2a plus adjuvant

Intramuscular doses of 0.5 mL

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Naval Medical Research Center

    collaborator FED

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Mark S. Riddle, MD Dr Ph · Navy Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-09-30

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 NCT02388009 on ClinicalTrials.gov