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

October 18, 2012 updated by: Valneva Austria GmbH

An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14050
        • Parexel International GmbH, Institute for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IC47 30 mcg
30 mcg with Alum
Biological: IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Experimental: IC47 30 mcg w/o
30 mcg without Alum
Biological: IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Experimental: IC47 150 mcg
150 mcg with Alum
Biological: IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Experimental: IC47 150 mcg w/o
150 mcg without Alum
Biological: IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of vaccine-specific IgG levels
Time Frame: Day 0 - Day 264
Day 0 - Day 264

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valneva Austria GmbH

Collaborators

PATH

Investigators

  • Study Director: Evelyn Hatzenbichler, PhD, Valneva Austria GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC47-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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