Tuesday, January 6, 2015

J&J's Phase I Ebola Vaccine Candidate Trial Is. . . Now Underway

Again, like GSK, J&J is taking the prime plus booster approach.

While that likely translates into more permanent immunity, it may not be workable in West Africa -- to stem the current tragic outbreak. People likely to need two doses will be hard to track, and follow-up with. On the plus side, the J&J candidate needs only ordinary refrigeration -- not the cryo-freeze of some high end vaccines. [I believe the NewLink Merck candidate is ordinary refrigeration transportable, as well -- and is slated to be a single course inoculation, at present.]

Longer term, in the EU, Japan, Australia, Canada and the US (primarily as a regiment for prospective tourists heading into West Africa), a "prime plus boost" vaccine might hold sway -- as follow-up/compliance is more easily mangaged in these post modern economies, generally speaking. Doubly so, if it is required in order to travel to (hopefully, by then) formerly affected geographies. But obviously, that overall market is smaller, by orders of magnitude, than an outbreak-stemming, perhaps population-wide inoculation program, country by country.

In any event, here's the bit, from The Wall Street Journal online:

. . . .J&J accelerated development of the vaccine regimen this fall as the Ebola virus continued to spread, overwhelming health-care systems across West Africa.

The regimen, developed in partnership with Denmark biotechnology company Bavarian Nordic , is the latest in a race to get vaccines into human testing—a crucial step in establishing whether an experimental therapy will work safely—and help curb the spread of the virus.

J&J said some volunteers have already received their initial vaccine dose, and enrollment is expected to wrap up by the end of the month. The early-stage clinical trial is being led by the University of Oxford’s pediatrics department. . . .

Stay bundled up, out there -- and the three way race is now well underway. I still think Merck holds a clear lead here, for the current outbreak.

1 comment:

Birdman said...

J&J/BN join the vaccine party. Two shots with ChAd3/MVA or the Ad26/MVA vaccine will limit their use for curtailing the outbreak. They may still be in competition for a "post outbreak" vaccine or a travelers vaccine as stated by Condor. I know for sure that the Bavarian Nordic component (MVA-Filo) requires -20C storage...as does the NL VSV-ZEBOV candidate. I assume the Ad26 component from JnJ also requires freezing.

So far the NL vaccine is planned as a single shot...we will have to wait to see how durable the response is. The "next generation" vaccines will be lyophilized (freeze dried). There is no time to develop the lyophilization procedure now...we need a vaccine now and will find a way to get it there frozen. There will be lots of funding available for the process development of a lyo procedure if the vaccine is protective.

From what I can see the JnJ/BN addition to the race will nearly be the last candidate into the vaccine race. I am surprised we have not yet heard from Profectus who received 8.6 million from HHS in October 2014 for their version of the VSV-ebola vaccine.

Profectus BioSciences Receives $8.6 Million HHS Contract to Accelerate Ebola Vaccine into Human Clinical Studies

Happy New Year and hopefully 2015 leads to the extinction of EBOV, or, at least, an end to the current outbreak.