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OpenTrials
Completed

NCT Number: NCT00873431

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

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH, Institute for Clinical Pharmacology

Berlin, State of Berlin, 14050, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IC47

Biological

solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84

Primary outcomes

  1. Occurrence of any SAEs (possibly)related to the study vaccine

    Time frame: Day 0 - Day 264

  2. Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine

    Time frame: Day 0 - Day 264

  3. Occurrence of solicited local and systemic AEs within 1 week after vaccination

    Time frame: Day 0 - Day 264

Secondary outcomes

  1. Determination of vaccine-specific IgG levels

    Time frame: Day 0 - Day 264

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Collaborators

  • PATH

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2009
Registry last updated
Oct 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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