« Return to News | Clinical Intelligence

iBio completes phase I trial of H1N1 vaccine

Friday, March 23, 2012 04:13 PM

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).

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.