Advertisement
 

doctorslounge.com

 
Powered by
Careerbuilder

 

                    Home  |  Forums  |  Humor  |  Advertising  |  Contact
   Ask a Doctor

   News via RSS

   Newsletter

   Infections

   News

 

 Conferences


   CME

   Forum Archives

   Diseases

   Symptoms

   Labs

   Procedures

   Drugs

   Links
   Specialties

   Cardiology

   Dermatology

   Endocrinology

   Fertility

   Gastroenterology

   Gynecology

   Hematology

   Infections

   Nephrology

   Neurology

   Oncology

   Orthopedics

   Pediatrics

   Pharmacy

   Primary Care

   Psychiatry

   Pulmonology

   Rheumatology

   Surgery

   Urology

   Other Sections

   Membership

   Research Tools

   Medical Tutorials

   Medical Software

 

 Headlines:

 
 

Back to Infectious Disease Articles

Thursday 27th July, 2006

 

H5N1 pandemic flu vaccine achieved a high immune response at a low dose of antigen in clinical trials.

 
 

tellfrnd.gif (30x26 -- 1330 bytes)send to a friend
 
prntfrnd.gif (30x26 -- 1309 bytes)printer friendly version
 

  Related
 
  H5N1 (avian / bird flu) pandemic educational information  
   

GlaxoSmithKline (GSK) plc today announced headline data showing that its H5N1 pandemic flu vaccine achieved a high immune response at a low dose of antigen. The vaccine, which uses a proprietary adjuvant, enabled over 80% of subjects who received 3.8?g of antigen to demonstrate a strong seroprotective immune response.

This level of seroprotection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines. Efficacy results at these levels of antigen dosage have also not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum.

Commenting on the data, JP Garnier, GlaxoSmithKline?s Chief Executive Officer, said: ?These excellent clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine. This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response.

There is still a lot more work to be done with this programme, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain. All being well, we expect to make regulatory filings for the vaccine in the coming months.?

The results were based on an interim analysis of a clinical trial conducted in Belgium which involved 400 healthy adults aged 18-60 years of age. The vaccine tested was produced from inactivated H5N1 virus and contained a novel, proprietary adjuvant. An adjuvant is an ingredient which stimulates the immune system and increases response to the vaccine. Trial participants were vaccinated twice during the course of the trial and four different levels of antigen dose were tested, with 3.8?g being the lowest dose assessed.

advertisement.gif (61x7 -- 0 bytes)
 

Are you a doctor or a nurse?

Do you want to join the Doctors Lounge online medical community?

Participate in editorial activities (publish, peer review, edit) and give a helping hand to the largest online community of patients.

Click on the link below to see the requirements:

Doctors Lounge Membership Application


In this study, immune response was defined as the increase in the number of antibodies an individual produced in response to the vaccine. Levels of antibody protection were established through measurement of hemagglutination inhibition (HI), hemagglutination being the clumping together of red blood cells, which cannot occur when antibodies are present. HI is a standard efficacy measure used in the evaluation of influenza vaccines, and an individual with an HI titer of greater than 40 is considered to be protected, or to have ?seroprotection.? In this clinical trial, over 80% of subjects, who received 3.8?g of antigen with adjuvant, demonstrated a seroprotective immune response. GSK?s adjuvanted investigational pandemic vaccine has not received marketing approval from any regulatory agency.

GlaxoSmithKline is one of the world?s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

 

 advertisement.gif (61x7 -- 0 bytes)

 

 



We subscribe to the HONcode principles of the HON Foundation. Click to verify.
We subscribe to the HONcode principles. Verify here

Privacy Statement | Terms & Conditions | Editorial Board | About us
Copyright 2001-2012 DoctorsLounge. All rights reserved.