Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: IC47

• Registration Number: NCT00873431
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.

A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.

Detailed Description

This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-18
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Written informed consent
• Healthy adults ≥ 18 to </= 65
• female subjects: post-menopausal or practicing reliable methods of contraception during the study

Exclusion Criteria

• History of autoimmune diseases and malignancies.
• History of severe hypersensitivity reactions and anaphylaxis.
• Immunodeficiency due to immunosuppressive therapy.
• Infection with HIV, Hepatitis B or Hepatitis C.
• Pregnancy, lactation
• Vulnerable subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC47 150 mcg	IC47	150 mcg with Alum
IC47 30 mcg	IC47	30 mcg with Alum
IC47 30 mcg w/o	IC47	30 mcg without Alum
IC47 150 mcg w/o	IC47	150 mcg without Alum

Primary Outcome Measures

Name	Time	Method
Occurrence of any SAEs (possibly)related to the study vaccine	Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine	Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination	Day 0 - Day 264

Secondary Outcome Measures

Name	Time	Method
Determination of vaccine-specific IgG levels	Day 0 - Day 264

Trial Locations

Locations (1)

Parexel International GmbH, Institute for Clinical Pharmacology; 🇩🇪 Berlin, Germany