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NCT Number: NCT01563263

Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43

This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

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Key information

Conditions

Pseudomonas Aeruginosa Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pseudomonas Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

LKH - University Clinic Graz, Graz, Austria

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About this study

This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent (i.e., from the patient or from the patient's legally authorized representative) or waiver will be obtained according to regional requirements prior to any study related procedures. Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU discharge occurs before Day 7, immunization will be done at the hospital ward.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0
  • written informed consent or waiver according to the national regulations
  • no childbearing potential or negative pregnancy test

Exclusion criteria

  • Sequential Organ Failure Assessment (SOFA) < 4 on Day 0
  • Patients <6 months post organ transplantation
  • readmission to ICU during the current total hospital stay on Day 0
  • patients admitted to ICU within 2 days after surgery
  • patients admitted to ICU due to trauma
  • elective surgery until Day 28 after first vaccination

Treatment and study plan

IC43

Biological

100 mcg

Other names: Pseudomonas Aeruginosa

Placebo

Drug

phosphate buffered saline (PBS) solution containing 0,9 % NaCl

Other names: phosphate buffered saline (PBS)

Primary outcomes

  1. number of deaths until Day 28

    Time frame: until Day 28

Secondary outcomes

  1. number of deaths in comparison on Day 14, 56 and 90

    Time frame: until Day 90

  2. number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo

    Time frame: until Day 90

  3. number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo

    Time frame: until Day 90

  4. number of overall survival in all patients and in patients surviving Day 14

    Time frame: until Day 180

  5. number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo

    Time frame: until Day 90

  6. number of surviving subjects after Sepsis receiving IC43 or placebo

    Time frame: until Day 180

  7. number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180

    Time frame: until Day 180

  8. percentage of patients with invasive infection with P. aeruginosa, such as bacteremia or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo up to Day 56 after first vaccination

    Time frame: until Day 56

  9. percentage of patients with P. aeruginosa respiratory tract infection or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo up to Day 56 after first vaccination

    Time frame: until Day 56

  10. Organ function in patients receiving IC43 or placebo during ICU stay

    Time frame: during ICU stay

  11. Days of ICU stay in patients receiving IC43 or placebo

    Time frame: Until Day 180

  12. Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo

    Time frame: until Day 180

  13. Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination

    Time frame: until Day 180

  14. systemic tolerability

    Time frame: until Day 7

    blood pressure

  15. number of local reactions at the injection site

    Time frame: until Day 180

  16. Composite measure of laboratory parameters

    Time frame: until Day 56

  17. systemic tolerability

    Time frame: until Day 7

    pulse

  18. systemic tolerability

    Time frame: until Day 7

    body temperature

Sponsors and collaborators

Lead sponsor

Valneva Austria GmbH

Industry

Registry information

Official study title

A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2012
Registry last updated
Mar 31, 2016

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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