NEW BRUNSWICK, NJ—Johnson & Johnson (J&J) announced on January 6 that it has started “first-in-human clinical trial” testing of its preventive Ebola-virus vaccine, manufactured by the company’s Janssen subsidiary.
“As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa,” said Alex Gorsky, Chairman and CEO of J&J.
“Different regimens combining the vaccine components or placebo will be studied in 72 healthy adult volunteers. Additional clinical studies are planned to begin in the United States later this month and soon after in Africa. Further details of the study are posted on clinicaltrials.gov,” said the company in a prepared statement.
Led by the Oxford Vaccine Group, part of the University of Oxford’s pediatric’s department, recruitment in the early-stage clinical trial is underway.
“We’ve been working at an unprecedented pace together with our partners to significantly accelerate our efforts,” said Dr. Matthew Snape of the Oxford Vaccine Group and the study leader.
“Initiating this study in the space of eight weeks represents a critical leap forward in being able to rapidly develop an Ebola prime-boost vaccine regimen, and these results will be vital to the design of future studies in broader populations.”
Human testing is a vital step in moving the experimental therapy forward and determining whether it is safe or not. According to the company, the first volunteers received their initial vaccine dose, and enrollment should be completed by the end of January.
As we reported, J&J partnered with Denmark-based biotechnology company Bavarian Nordic, to develop a combination vaccine, or “regimen.”
J&J also announced on January 8 that it has produced over 400,000 regimens for use in large-scale human testing (clinical trials) by April 2015 with a total of 2 million regimens available through the course of this year.
The global healthcare giant says that it has the ability to “quickly scale up to 5 million regimens, if required, over a 12- to 18-month period.”
Janssen’s previous goal was to produce more than 1 million regimens by the end of 2015, with 250,000 regimens for “broad application in clinical trials” by May.
“Because every day counts, we are substantially accelerating the production of our vaccine regimen,” said Dr. Paul Stoffels, J&J’s Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals.
“Through the unprecedented collaboration among the global health community, our goal is to bring this vaccine to families and frontline health care professionals as fast as possible.”
The human trials “will evaluate the safety and tolerability of a prime-boost vaccine regimen, in which patients are first given a dose to prime the immune system, and then a boost intended to enhance the immune response over time,” says J&J.
The GAVI Vaccine Alliance, a leading public-private partnership organization, gave J&J and other vaccine developers a reason to move quickly.
On December 11, the alliance said it would commit up to $300 million to procure vaccines as soon as a safe and effective one is recommended for use by the World Health Organization (WHO).
J&J said it invested $200 million to help Bavarian Nordic build a facility to make its part of the prime-boost vaccine combination.
“The Ebola outbreak reminds us of the critical importance of vaccines in fighting infectious diseases,” said Gavi CEO Dr. Seth Berkley.
“The Board’s decision underlines Gavi’s commitment to support the people of the Ebola-affected countries by ensuring that they will have access to a WHO-recommended vaccine as soon as one is approved and available from manufacturers
“Gavi has a responsibility to those in need,” said Gavi Board Chair Dagfinn Høybråten.
“We are making determined efforts to ensure that people living in Ebola-affected countries are protected as soon as possible and do not have to face another terrible outbreak in the future.”
“We’ve had individual discussions with all of the manufacturers and continue to work closely with them,” GAVI’s chief executive, Seth Berkley, told Reuters News.