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

Pneumococcal Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873431
• Other study ID #: IC47-101
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: October 18, 2012
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2012
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84

Locations

Country	Name	City	State
Germany	Parexel International GmbH, Institute for Clinical Pharmacology	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Valneva Austria GmbH	PATH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any SAEs (possibly)related to the study vaccine		Day 0 - Day 264	Yes
Primary	Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine		Day 0 - Day 264	Yes
Primary	Occurrence of solicited local and systemic AEs within 1 week after vaccination		Day 0 - Day 264	Yes
Secondary	Determination of vaccine-specific IgG levels		Day 0 - Day 264	No