GlaxoSmithKline Plc (GSK)’s Ebola vaccine produced responses from the immune system and didn’t raise safety concerns in a study with 20 healthy adults, completing an initial step toward making it widely available.
The participants in the early-stage clinical trial in Maryland all produced antibodies, according to a preliminary report published yesterday in the New England Journal of Medicine. Two participants developed brief fevers within a day of vaccinations, but there were no serious adverse effects.
“It’s good news,” said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, which is developing the vaccine with Glaxo. “If it was very toxic or didn’t induce good immune response, we couldn’t go on to the next step, but the proof of the pudding is efficacy.”
The tests showed that trial participants’ immune systems responded similarly to animals that gained protection from the virus after getting the vaccine, Fauci said. “It did what I hoped it would do.”
Glaxo and drugmakers including NewLink Genetics Corp. and Johnson & Johnson are racing to create a vaccine as the Ebola outbreak in West Africa continues to spread, with more than 15,000 infections and more than 5,600 deaths so far, according to the World Health Organization.
The Glaxo product will still require more trials to show it’s effective. The vaccine, based on a chimpanzee virus, carries genetic material from two strains of the Ebola virus. The vaccine can’t infect people with Ebola. Instead, it teaches the body to recognize Ebola and prepares the immune system to attack it in case of an infection.
Besides producing antibodies that specifically recognize Ebola, trial participants also produced more of a specific type of T-cell that is part of the body’s mechanism to hunt and kill viruses. Four weeks after being vaccinated, the killer T-cells were detected in two volunteers who received the lower dose and seven who got the higher dose.
The results show that the higher dose should be used, said Fauci by telephone.
“We are very encouraged by these positive first trial results,” Moncef Slaoui, Glaxo’s chairman of global vaccines, said in a statement. “It’s important to remember that these data are the first piece in the jigsaw and we’re continuing to gather other important information.”