London, Oct 18 : The first study to test GlaxoSmithKline's (GSK) investigational RTS,S/AS02 malaria vaccine in African infants has shown that the drug lessens malaria parasite infection and clinical illness caused by malaria.

The study finds that vaccine efficacy is 65 pct for a three-month period after infants were given three doses of the vaccine, and that it has a safety and tolerability profile.

It was also found that the vaccine reduced clinical illness due to malaria by 35 pct over a half-year period.

Though a large-scale Phase III study is essential to establish the efficacy of the vaccine, the results of the new study is encouraging.

The main objective of the study was to evaluate whether the vaccine should be cautiously administered for the age group more susceptible to malaria.

"We have shown for the first time that a vaccine can reduce the risk of malaria infection in young African infants exposed to intense P. falciparum transmission," Lancet quoted CISM's Pedro Alonso, MD, PhD, senior author of The Lancet article, principal investigator of the study, and head of the Barcelona Center for International Health Research (CRESIB) at the Hospital Clinic of the University of Barcelona, as saying,

"These tantalizing and unprecedented results further strengthen the vision that a vaccine may contribute to the reduction of the intolerable burden of disease and death caused by malaria,’ he added.

"We have invested over US$300 million in the development of this vaccine to make it as safe and effective as possible," said Jean Stéphenne, president of GSK Biologicals, the vaccine division of GSK.

"Our collaboration with the PATH Malaria Vaccine Initiative and CISM, which dates back to 2001, demonstrates how public-private partnerships can help overcome critical health problems in Africa. Anticipating licensure, we are already working with our partners and with international donors to ensure that this vaccine is affordable and available to all who need it,” Stephenne added.

"While other Phase II studies of this vaccine candidate are underway, this study helps pave the way for a pivotal Phase III trial of what could be the first malaria vaccine for infants and young children in Africa," added Christian Loucq, MD, director of the PATH Malaria Vaccine Initiative.

"The world urgently needs a safe and effective vaccine to reduce the suffering malaria causes,” Loucq said.

The RTS,S vaccine is a combination of P.falciparum circumsporozoite protein (CSP) with hepatitis B surface antigen. Fused with a proprietary GSK Adjuvant System, RTS,S triggers the production of antibodies and T cells that hamper the ability of the malaria parasite to infect humans.

If the results continue offering promising results, the trial will move on to a Phase III trial. (ANI)