Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Intercell Reports Positive Results From Its Phase II Pseudomonas Aeruginosa Investigational Vaccine Study for Certain Hospital-Acquired Infections

October 25, 2010 By Bio-Medicine.Org

VIENNA, Oct. 25 /PRNewswire-FirstCall/ — Intercell AG (VSE:
ICLL) today announced results from a Phase II clinical trial
involving the company’s investigational nosocomial vaccine
candidate (IC43) against infections with the bacterium
Pseudomonas aeruginosa, a leading cause of
hospital-acquired infections with increasing antibiotic resistance
and hence a very high unmet medical need.

In the randomized, controlled Phase II clinical trial (33 sites
in 8 countries), about 400 mechanically ventilated intensive care
patients, who are at particular high risk of acquiring severe and
often life-threatening forms of Pseudomonas
aeruginosa infections, such as Ventilator-Associated
Pneumonia (VAP), sepsis or soft tissue infection were vaccinated on
days zero and seven in four treatment groups  receiving 100 or
200mcg alum-adjuvanted vaccine, 100mcg non-adjuvanted vaccine or
alum as placebo control.

The primary endpoint of the study was met in that all vaccine
groups showed good seroconversion rates (65 – 81%) with IgG
antibody Geometric Mean Titers (GMTs) (995-2117 ELISA units/ml).
There were no significant differences in treatment emergent adverse
events between the treatment arms and local and systemic
tolerability appeared to be good, as far as assessable in this
study population. The number and nature of reported drug related
adverse events does not raise any safety concern and has been
confirmed earlier by a Data Safety Monitoring Board (DSMB) based on
interim data.

Secondary immunogenicity endpoints were also met in this study
and included IgG response assessed seven times over a period of 90
days, measurement of functional antibody activity by
opsonophagocytosis assay, and measurement of antibody avidity.

Overall robust immunogenicity following second vaccination was
observed in all vaccine groups. A dose-response could be observed,
whereas alum did not show a clear immune-enhancing effect. Antibody
avid

‘/>”/>

SOURCE

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech