Health authorities and pharmaceutical companies are planning to test several new vaccines to prevent Ebola infection over the next few months, including one that is taken as a tablet, making it easier to deploy in West Africa.
The plans signify that a response to the Ebola outbreak is finally gathering steam. It is still unclear if any of these vaccines will work, however, and even if they do, they may not be ready in time to help stem the current epidemic.
Starting in January, two vaccines will be tested in large studies in the West African countries most affected by the outbreak, the World Health Organization said on Tuesday. At least three other vaccines will begin safety testing in healthy volunteers outside the outbreak zone in the first quarter of 2015.
One of those three is actually a combination of two inoculations being developed by Johnson & Johnson and Bavarian Nordic, a Danish company.
Johnson & Johnson announced early Wednesday that it was committing $200 million to the program, including making an equity investment of about $43 million in Bavarian Nordic to help pay for that company’s part in the project. It says it plans to begin safety trials in January and hopes to produce one million doses in 2015, with 250,000 available for broad application in clinical trials by May.
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“Typically, you don’t make hundreds of thousands of vaccines before you know what the safety and immunogenicity is,” said Dr. Paul Stoffels, chief scientific officer of Johnson & Johnson. “This time, we will do that.”
The two most advanced vaccines in terms of development is each undergoing testing in about 250 healthy adult volunteers in the United States and other countries outside the outbreak region.
One of the vaccines was developed by the National Institutes of Health and GlaxoSmithKline. The other was initially developed by the Public Health Agency of Canada and licensed to NewLink Genetics, a company in Iowa.
The studies, known as Phase 1 clinical trials, are determining if the vaccines are safe and generate an immune response. Preliminary results are expected by the end of the year, Marie-Paule Kieny, the World Health Organization’s assistant director general for health systems and innovation, said in a news conference in Geneva on Tuesday.
But she said her organization was not waiting for those results. It is already planning the next stage of testing, to be ready to start in January if the vaccines pass the initial tests. Those new trials will take place in the affected countries in West Africa and would involve tens of thousands of doses, she said.
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There are various scientific and ethical issues to be worked out, including who should receive the vaccine and whether it would be ethical to give some participants a placebo instead. Initial studies are likely to involve health care workers but might also involve others at high risk of infection.
“We are doing everything we can to produce as many doses as we can as quickly as we can,” said Dr. Ripley Ballou, who leads the vaccine effort for GlaxoSmithKline.
Dr. Ballou said that while Glaxo would not have enough doses to vaccinate millions of Africans against Ebola, there should be enough by sometime next year to help slow the outbreak by protecting health care workers or those close to infected people.
Dr. Kieny said that three other vaccines would be ready early next year to enter Phase 1 testing, starting with the combination from Johnson & Johnson and Bavarian Nordic.
A second is being developed by Inovio Pharmaceuticals, a small company in Plymouth Meeting, Pa. The third is from Protein Sciences of Meriden, Conn., which already sells a flu vaccine.
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Dr. Kieny also said her organization was trying to find out more about vaccines being developed in Russia.
She did not mention the tablet vaccine, which Vaxart, a privately held company in South San Francisco, Calif., is developing.
Wouter Latour, the chief executive, said in an interview that, after recent discussions with the Food and Drug Administration, the company hoped to start a Phase 1 safety trial toward the end of the first quarter of 2015.
“This is ideal to bring to bear on the Ebola crisis,” Dr. Latour said. Not only is it not injected but it is stable at room temperature. Some of the other vaccines must be stored at minus 80 degrees Celsius, which might be difficult in parts of West Africa.
Dr. Latour said Vaxart’s vaccine protected mice against Ebola but is only now being tested in monkeys. But an experimental flu vaccine developed using the same approach has already been tested in a small number of people. It generated immune responses comparable to or even better than approved flu vaccines, the company’s chief scientist said in a presentation last week at the World Vaccine Congress in Brussels.
Another company, Profectus BioSciences of Baltimore, received federal funding last week to move its Ebola vaccine toward clinical trials.