NCT01296386

An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

An Open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, a New Vaccine Against Clostridium Difficile, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects

Detailed description

This is an open-label, partially randomized, dose escalation Phase 1 study which will consist of a part A in healthy adults aged between ≥18 and \<65 years and a part B in healthy elderly ≥65 years, the latter age group being the most vulnerable population to suffer from C. difficile infections. Part A consists of 3 vaccinations on Day0, Day7 and Day21 with the following groups: Group A: IC84 20 mcg (microgram)with Alum Group B: IC84 75 mcg (microgram)with Alum Group C: IC84 75 mcg (microgram)without Alum Group D: IC84 200 mcg(microgram)with Alum Group E: IC84 200 mcg(microgram)without Alum Part A was already finished and part B is now ongoing. All information which could be find under the other sections are referring to the information on Part B.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	IC84	IC84, a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B, which will be administered at two different doses: 75 and 200 µg without or with Al(OH)3, respectively, intramuscular (i.m.) injection, four vaccinations on Day 0, 7, 28 and 56.

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-02-15
• Last updated: 2014-09-25

Locations

3 sites across 2 countries: Austria, Hungary