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

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Valneva

Status and phase

Completed
Phase 1

Conditions

Pneumococcal Infections

Treatments

Biological: IC47

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00873431
IC47-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

32 participants in 4 patient groups

IC47 30 mcg
Experimental group
Description:
30 mcg with Alum
Treatment:
Biological: IC47
IC47 30 mcg w/o
Experimental group
Description:
30 mcg without Alum
Treatment:
Biological: IC47
IC47 150 mcg
Experimental group
Description:
150 mcg with Alum
Treatment:
Biological: IC47
IC47 150 mcg w/o
Experimental group
Description:
150 mcg without Alum
Treatment:
Biological: IC47

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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