GlaxoSmithKline's Ebola vaccine rolls into Phase III as outbreak simmers

Vaccines Chairman Moncef Slaoui

GlaxoSmithKline ($GSK) has shipped out the first batch of its in-development Ebola vaccine, expecting to kick off late-stage studies in the coming weeks.

The shipment, containing 300 vials, is due to arrive in Liberia today, the company said, fueling a National Institutes of Health-sponsored effort to get a handful of potential treatments for the virus through Phase III development. NIH is hoping to enroll about 30,000 people in the trial, focusing on frontline healthcare workers in Ebola-affected nations. About one-third of those patients will get GSK's shot, the company said, comparing it with a control vaccine to determine its efficacy in preventing infection.

GSK's candidate, developed alongside the NIH's National Institute of Allergy and Infectious Diseases, proved itself safe and charted a promising immune response in Phase I, and Vaccines Chairman Moncef Slaoui said the company is hopeful it can deliver in Phase III.

"If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks," Slaoui said in a statement. "It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether WHO, regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made."

Ebolavirus under an electron microscope--Courtesy of CDC

Meanwhile, the WHO has said that the outbreak of Ebola in West Africa has slowed over the past few months but cautioned that there is much work to be done to contain its spread. Since Ebola broke out last year, WHO has tracked more than 20,000 reported cases and nearly 9,000 deaths.

GSK's candidate is the furthest along among Ebola vaccines in development, leading efforts from partners Merck ($MRK) and NewLink Genetics ($NLNK) and the team of Johnson & Johnson ($JNJ) and Bavarian Nordic. Separately, regulators have fast-tracked treatments from Fujifilm, Mapp Biopharmaceutical and Chimerix ($CMRX) in hopes of finding a cure for the infection.

- read the statement

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.