U.S. scientists will begin enrolling patients next week in safety trials of GlaxoSmithKline Plc’s experimental Ebola vaccine as the death toll from the disease rises in West Africa.
The National Institutes of Health’s Vaccine Research Center got approval from the Food and Drug Administration to start the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, said yesterday in a telephone interview. A Phase 1 trial is the first test of a therapy in humans to assess safety and whether it works similarly to how it does in animals.
The current outbreak has killed 1,552 people in four countries and may soon claim more deaths than all previous Ebola outbreaks combined. The NIH and London-based Glaxo are jointly developing the experimental vaccine, which doesn’t contain any infectious Ebola virus.
It’s unclear when the vaccine will be available for at-risk people, Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said on a call with reporters today.
“You’re dealing with something you’re going to give to a normal human being who is not ill,” Fauci said. “Safety is paramount.” The safety trials could produce initial data by the end of the year, he said.
Researchers will enroll three healthy volunteers next week. After the first round of people gets the vaccine, researchers will monitor them for three days before giving it to the next round, Fauci said. Anyone between 18-50 years old can volunteer, he said. Researchers plan to enroll 20 patients.
The trials will be conducted at the NIH’s clinical center in Bethesda, Maryland, according to a statement. The agency said it will also test NewLink Genetics Corp.’s vaccine.
Glaxo said other tests of its vaccine are waiting on regulatory approval and could start in mid-September on 60 volunteers, the result of a partnership between NIH and a British-based international consortium. The tests would be conducted on healthy people in the U.K., Gambia and Mali, Glaxo said in a statement today, and are being led by researchers at the University of Oxford.
Provided there are no adverse effects, trials will extend to 40 volunteers in Mali and the same number in Gambia. The first phase could be completed by the end of the year, Glaxo said. A 2.8 million-pound ($4.6 million) grant from the U.K. government and the Wellcome Trust will fund the testing and manufacturing of as much as 10,000 doses of the vaccine. If the trials are successful, the medicine will immediately be available for immunization programs.
U.S. officials also are discussing whether they could conduct a vaccine trial in Nigeria, Fauci said.
NewLink, based in Ames, Iowa, said yesterday it has contracted with a third party to manufacture its vaccine and add to its current supply.
The World Health Organization is scheduled to meet next week and discuss Ebola drugs and vaccines under development.
Treatments include those from Mapp Biopharmaceutical Inc., Fujifilm Holdings Corp., BioCryst Pharmaceuticals Inc. and Tekmira Pharmaceuticals Corp., said Kurilla, who will serve as an expert at the meeting.
Mapp’s experimental medicine ZMapp is “front and center in terms of what people consider a good intervention,” he said.
Some Ebola patients, including American health workers Kent Brantly and Nancy Writebol, have been treated with ZMapp though the closely held San Diego-based company has said their supply is exhausted.
WHO advisers determined earlier this month experimental treatments against Ebola are ethical to use to help infected patients. More than 2,600 cases have been reported in Liberia, Guinea, Sierra Leone and Nigeria since December, the WHO has said.
Kurilla expects the WHO to also discuss a class of drugs known as selective estrogen receptor modulators as a possible treatment. Scientists published research last year in the journal Science Translational Medicine showing such drugs, which are hormone therapies used to treat breast cancer and infertility, may work against Ebola.