In a big week for Ebola vaccines, Emergent Biosciences and GlaxoSmithKline have begun a Phase I trial of their candidates, while Bavarian Nordic received €50 million ($56 million) in loans from the European Investment Bank that go in part toward its programs in Ebola and infectious diseases.
The Phase I trial of Emergent BioSolutions' ($EBS) MVA EBOZ and GlaxoSmithKline's ($GSK) ChAd3--announced in March--is finally underway at Oxford University. Thirty-eight patients enrolled in the study, which will assess the use of Emergent's candidate as a booster shot for ChAd3. Six patients will only receive MVA EBOZ and 32 will receive GSK's shot followed by the MVA EBOZ booster.
|GSK R&D Chairman Moncef Slaoui|
"We believe there is benefit in exploring different approaches such as a prime-boost strategy as we continue to develop our ChAd3 Ebola candidate vaccine," Moncef Slaoui, GSK's vaccines chief, said in a statement. "This ChAd3 Ebola candidate vaccine has shown encouraging immune responses and an acceptable safety and reactogenicity profile in ongoing Phase I trials to date. Together, these different trials will provide important information about the vaccine and its potential to help combat this or future Ebola outbreaks."
While Glaxo and Emergent are the first to test one candidate as a booster for another, Bavarian Nordic and partner J&J ($JNJ) were the first to develop a two-dose regimen, or a prime-boost vaccine. While a booster could improve an immune response that is primed by the first dose, a two-dose vaccine could complicate mass immunization.
Other companies working on Ebola jabs include Merck ($MRK) and NewLink ($NLNK), which are testing their candidate in Africa. Profectus BioSciences scored funding from BARDA last year to take its candidate into clinical trials, while Maryland-based Novavax ($NVAX) is working on a nanoparticle vaccine.
But the waning of a yearlong epidemic is a roadblock for vaccinemakers, as they will not be able to gather data on how vaccines fare against actual Ebola infection. The FDA's advisory committee for vaccines and related biological products met Tuesday to discuss alternate pathways to approval and licensure for Ebola vaccines. The committee discussed alternatives to the traditional approval pathway, accelerated approval and "animal rule" approval. The first involves approval based on a surrogate endpoint that is "reasonably likely" to predict clinical benefit, and the second is approval based on results from animal studies that show it is "reasonably likely" that humans would benefit as well. Both routes require postapproval testing.
- here's the GlaxoSmithKline/Emergent release
- here's the Bavarian Nordic release
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