MedTrace Logo

Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella

NCT01069471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-10-13

No results posted yet for this study

Summary

Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1. Blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Shigella vaccine

Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.

Sponsors & Collaborators

  • GlycoVaxyn AG

    lead INDUSTRY

Principal Investigators

  • Christoph Hatz, Prof. Dr. · Institute of Social and Preventive Medicine

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
2010-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Switzerland

Study Locations

More Related Trials

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 NCT01069471 on ClinicalTrials.gov