A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Valneva Austria GmbH
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
IC43 100 mcg
IC43 100 mcg with Aluminum hydroxide
Intervention: IC43 (Biological)
IC43 200 mcg
IC43 200 mcg with Aluminum hydroxide
Intervention: IC43 (Biological)
IC43 100 mcg w/o
IC43 100 mcg without Aluminum hydroxide
Intervention: IC43 (Biological)
Placebo
phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Time Frame: Day 14
Secondary Outcomes
- Rate of serious adverse events(Day 7)
- Safety laboratory parameters(Day 7)
- Immunogenicity at day 7(Day 7)
- Systemic tolerability(Day 7)
- Local tolerability(Day 7)