Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Valneva

Status and phase: Completed; Phase 2

Conditions: Pneumonia, Ventilator-Associated

Treatments: Biological: IC43; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876252

IC43-201

Details and patient eligibility

About

Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.

Full description

This is a randomized, placebo-controlled, multi-center, partially blinded [i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non-adjuvanted IC43 [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Enrollment: 400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged between 18 and 80 years
• Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
• At high risk for acquiring infection against P. aeruginosa at visit 0.
• Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
• In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
• Written informed consent or waiver according to the national regulations

Exclusion criteria

• Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
• Low severity of illness defined by an acute physiology score < 8 at visit 0
• Patients < 6 months post organ transplantation
• Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
• Pregnancy, lactation
• Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 4 patient groups, including a placebo group

IC43 100 mcg

Active Comparator group

Description:

IC43 100 mcg with Aluminum hydroxide

Treatment:

Biological: IC43

IC43 200 mcg

Active Comparator group

Description:

IC43 200 mcg with Aluminum hydroxide

Treatment:

Biological: IC43

IC43 100 mcg w/o

Active Comparator group

Description:

IC43 100 mcg without Aluminum hydroxide

Treatment:

Biological: IC43

Placebo

Placebo Comparator group

Description:

phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant

Treatment:

Drug: Placebo