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

This study has been completed.
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00873431
First received: March 31, 2009
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Pneumococcal Infections
Biological: IC47
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Occurrence of any SAEs (possibly)related to the study vaccine [ Time Frame: Day 0 - Day 264 ] [ Designated as safety issue: Yes ]
  • Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine [ Time Frame: Day 0 - Day 264 ] [ Designated as safety issue: Yes ]
  • Occurrence of solicited local and systemic AEs within 1 week after vaccination [ Time Frame: Day 0 - Day 264 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of vaccine‐specific IgG levels [ Time Frame: Day 0 - Day 264 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873431

Locations
Germany
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
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00873431     History of Changes
Other Study ID Numbers: IC47-101
Study First Received: March 31, 2009
Last Updated: October 18, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Valneva Austria GmbH:
Prevention of pneumococcal infections

Additional relevant MeSH terms:
Infection
Pneumococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on October 21, 2014