Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
spacer.gif (43 bytes)
SafetyAlerts
December 14,  2001

Antigenics' Immune Adjuvant Shows Benefit In Preventing Malaria In Randomized Trial

 

(SafetyAlerts) - Antigenics Inc. announced today the publication of clinical results of a malaria vaccine containing the company's immune response enhancer, QS-21, which showed significant protection against the most widespread and dangerous forms of malaria. The study, published in the December 8 issue of The Lancet, is titled "Efficacy of RTS,S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomized trial."

GlaxoSmithKline Biologicals (GSKB) is developing the vaccine for the treatment of malaria. Currently named RTS,S/AS02, it is produced by combining a malaria antigen with an adjuvant formulation that contains QS-21.

In the 250 men who completed the study in The Gambia, West Africa, the vaccine was found safe and immunogenic. It induced strong antibody responses to circumsporozoite protein and strong T-cell responses. This is the first pre-erythrocytic vaccine to show significant protection against natural P. falciparum.

The effectiveness of QS-21 has been evaluated in approximately 50 Phase I, II and III trials involving more than 3,000 patients. QS-21 has been shown to enhance the quality and quantity of the immune response to a variety of antigens including those associated with malaria. Specifically, in a study published in the New England Journal of Medicine, January 9, 1997, researchers from the Walter Reed Army Institute of Research in Washington, DC and SmithKline Beecham Biologicals found that the RTS,S vaccine combined with QS-21 protected against experimental challenge with P falciparum parasites in six of seven patients. The RTS,S vaccine alone protected only two of seven patients and the vaccine combined with alum (another adjuvant) only protected one patient of eight from contracting malaria.

QS-21 is also a key component in several other vaccines under development including Elan/American Home Product's AN-1792 for Alzheimer's Disease and VaxGen's product for HIV.

Malaria is an acute and chronic parasitic disease caused by the protozoan parasites of the genus Plasmodium and spread by the bite of the female Anopheles mosquito. P falciparum is the most widespread and dangerous of the malaria parasites, as it is responsible for most of the severe forms of the disease, as well as the majority of the deaths. The incidence of malaria is estimated to be between 300 and 500 million clinical cases each year. Furthermore, malaria accounts for more than 1 million deaths each year. In particular, malaria is a significant cause of infant and juvenile mortality, causing approximately 800,000 deaths in children under the age of five annually. Although the disease was previously widespread, malaria now occurs primarily in Africa, Asia and South and Central America.

Source: PRNewswire.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.