• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » iBio completes phase I trial of H1N1 vaccine

iBio completes phase I trial of H1N1 vaccine

March 23, 2012
CenterWatch Staff

Chicago-based biotech iBio has completed its first human trial of iBioLaunch-produced H1N1 influenza vaccine (HAC1) assessing safety, reactogenicity and immunogenicity.

The single-blind, placebo-controlled, dose escalation study—which began in September, 2010—confirmed the results of the June, 2011, announcement that HAC1 was safe and well tolerated at all dose levels, with or without adjuvant. There were no reported serious adverse events or dose-limiting toxicities, nor any subject withdrawals due to adverse events.

The analyses also showed that the HAC1 vaccine elicited high levels of immune responses which correlated directly with the amount of antigen administered when the vaccine was not adjuvanted. The immune response was the highest in subjects who received the non-adjuvanted highest HAC1 dose that was comparable with the immune response of the licensed, control H1N1 vaccine.

HAC1 was produced by iBio's research collaborator, the Fraunhofer USA Center for Molecular Biotechnology. The trial was supported by funding from the Defense Advanced Research Projects Agency (DARPA) and was conducted at the Walter Reed Army Institute of Research Clinical Trials Center (WRAIR-CTC).

Upcoming Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing