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

Sponsor
Valneva Austria GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00873431
Collaborator
PATH (Other)
32
Enrollment
1
Location
4
Arms
11.1
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: IC47
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
An Open-Label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC47, a New Vaccine Against Streptococcus Pneumoniae, in Healthy Subjects.
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Occurrence of any SAEs (possibly)related to the study vaccine [Day 0 - Day 264]

  2. Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine [Day 0 - Day 264]

  3. Occurrence of solicited local and systemic AEs within 1 week after vaccination [Day 0 - Day 264]

Secondary Outcome Measures

  1. Determination of vaccine-specific IgG levels [Day 0 - Day 264]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel International GmbH, Institute for Clinical Pharmacology Berlin Germany 14050

Sponsors and Collaborators

  • Valneva Austria GmbH
  • PATH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00873431
Other Study ID Numbers:
  • IC47-101
First Posted:
Apr 1, 2009
Last Update Posted:
Oct 19, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Valneva Austria GmbH
Prevention of pneumococcal infections
Additional relevant MeSH terms:
Pneumococcal Infections

Study Results

No Results Posted as of Oct 19, 2012