
Experimental Ebola vaccine appears safe, prompts immune response - adamnemecek
http://www.nih.gov/news/health/nov2014/niaid-28.htm
======
jared314
I am excited, but I would rather wait until a Phase 3 result before getting my
hopes up. Phase 1 is just to verify that the vaccine doesn't kill you all by
itself.

[http://en.wikipedia.org/wiki/Clinical_trial#Phases](http://en.wikipedia.org/wiki/Clinical_trial#Phases)

It might also be good to remember some of the history around why this
structure is in place.

The Battle to Beat Polio:
[http://youtu.be/qMRgQhbSyqs?t=18m50s](http://youtu.be/qMRgQhbSyqs?t=18m50s)

~~~
irq11
In the case of vaccines, phase one trials tell you if there's an immune
response to the antigen being used. This is a good first approximation of
effectiveness.

The level of response could still be too low, but at least there's something
happening.

------
rgbrenner
It's been a while since I've seen anything on HN about the Ebola outbreak.. so
here's the current news if anyone's interested:

Number of Ebola infections in west Africa passes 16,000
[http://www.theguardian.com/world/2014/nov/29/ebola-
infection...](http://www.theguardian.com/world/2014/nov/29/ebola-infections-
west-africa-16000)

CDC chart: [http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-
africa/cumu...](http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-
africa/cumulative-cases-graphs.html)

------
tim333
Cool. I hope they now try giving the virus to health workers in west Africa
rather than mucking about with US trials while thousands die out there.

~~~
tim333
For those down voting, there are about 1500 new cases a week currently of
which say 1000 will die. If you delay using the vaccine for a couple of years
while doing normal phase 2 and 3 trials then even with linear growth that
would be approx 100,000 nasty deaths. In comparison about the worst that has
happened using vaccines too early was about 20 people killed in by the early
polio vaccines and accidental deaths now would probably be about zero given
better science. Would it be worth having 100,000 extra deaths so conventional
procedures can be respected? Why not proceed in a way calculated to minimise
overall deaths and suffering?

~~~
hga
One thing you're forgetting is that it'll take a Maximum Effort to actually
get mass quantities of people vaccinated. Especially if the vaccine requires
refrigeration.

This, in an environment where fear, a common feature to all deadly epidemics,
is a primary driving force.

Any significant fraction of vaccine administrations resulting in morbidity or
mortality, or having to do it all over again with an actually effective
vaccine ... well, it won't end well. I'm not sure you'd get a second try with
another one.

~~~
icegreentea
Yes. But notice that the original poster said to give this thing to health
care workers first. I think that's a fairly reasonable position to take given
that the confidence in the safety of the vaccine is high, and that even if the
health care workers were given the vaccine, they should be following the same
decontamination/personal protection protocols anyways (for person health
reasons - no vaccine is 100% perfect and for public health reasons - it
minimizes cross infection).

In addition, it is possible to do accelerated Phase 2/3 in Africa. This is
also a compromise position. In this scheme, they would likely dispense a few
thousand vaccines in a relatively highly developed, but still high risk area
to aid in their ability to track efficacy. From the NIH FAQ on Ebola vaccines
([http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxResultsQA.asp...](http://www.niaid.nih.gov/news/QA/Pages/EbolaVaxResultsQA.aspx))

    
    
      Given the encouraging results of the bivalent version of the NIAID/GSK experimental Ebola vaccine at the NIH Clinical Center, are there plans for Phase 2/3 clinical trials in West Africa?
    
      NIAID is in active discussions with Liberian officials and other partners about next-stage vaccine testing in West Africa. The goal of these studies would be to test efficacy and safety of the NIAID/GSK vaccine compared to other Ebola vaccine candidates prior to wider vaccine distribution. Phase 2/3 clinical trials are designed to inform efficacy—whether or not the vaccine works—and provide additional critical safety data. Plans for such studies are dependent on additional safety and immunogenicity data derived from the currently ongoing clinical trials. Announcements about larger-scale testing will not be made until early 2015. 
    

Keep in mind that is basically is impossible to do Phase 2 and 3 testing in
North America given the fact that there basically isn't any Ebola there at
all.

~~~
hga
Indeed. And after testing it on volunteers in the U.K. and maybe US (it is
being tested in Bethesda by the NIH, I don't know the timing), this particular
vaccine is being tested on volunteer healthcare workers in Mali, see e.g.
[http://www.citypress.co.za/news/africas-first-ebola-
vaccine-...](http://www.citypress.co.za/news/africas-first-ebola-vaccine-
trial-starts-mali/) (I think they've tested it on more people since that
article, you no doubt want to go a bit slowly since many of the worst
reactions are fairly quick). And I think there are some other African
locations scheduled.

Vaccines and epidemics are a pretty well understood concepts after all (ignore
the "public health" types who are obsessed with lifestyle etc. issues to the
detriment of infectious diseases, like the current head of the CDC), there's
no surprise people are attempting to Do The Right Thing with these candidate
vaccines. E.g. as I note elsewhere in this discussion, this one is in the
process of being produced at an intermediate scale of 10,000 doses, which is a
necessary step before true mass production.

~~~
tim333
Update - they do seem to be trying to crack on:

"Ebola Vaccine May Be Ready as Early as January 2015"

"If further clinical trials result in an effective vaccine, health care
workers who treat those with Ebola will likely be the first to receive it."

[http://newsone.com/3074615/ebola-vaccine-may-be-ready-as-
ear...](http://newsone.com/3074615/ebola-vaccine-may-be-ready-as-early-as-
january-2015/)

------
mknits
What it's cost?

~~~
teddyh
That’s not nearly as interesting a question as “Is it _patented_?”.

~~~
delecti
Well it's really nearly the same question isn't it?

~~~
teddyh
No, not really. If it _is_ patented, the owner of the patent might charge a
lot for it, or they might give out licenses cheaply out of the goodness of
their hearts. If it is _not_ patented, it might be cheap if there are many
manufacturers, or it might be expensive if there are few manufacturers (for
whatever reason). It might also be intrinsically expensive to manufacture, in
which case the result will also necessarily be expensive.

So really, the questions are nearly _completely_ unrelated.

~~~
not_kurt_godel
The cost to manufacture is still quite interesting.

~~~
hga
Although in this era of modern biotechnology, especially for a 3rd World
targeted vaccine, it would be appalling to develop one that was expensive to
manufacture. I.e. nothing like the standard old flu vaccine, which is grown in
the membranes of chicken eggs, yielding about 3 doses from each egg. Compare
to e.g. the Protein Sciences method, which uses genetically modified insect
cells in a bioreactor, which as I recall produces about 100,000 doses in a
week or so (although it normally takes another 5-7 weeks to finish the vaccine
once a batch of raw antigen is done).

------
dang
Url changed from [http://www.iflscience.com/health-and-medicine/ebola-
vaccine-...](http://www.iflscience.com/health-and-medicine/ebola-vaccine-
passes-first-human-trial), which quotes from it without referencing it.

------
restlessdesign
Convenient timing!

------
tomjen3
Well why are we not starting to mass produce it then? Yeah yeah normally we
would wait years and do a lot of tests but people are dying _now_ and we have
already given experimental medication, so that ethical level has been crushed.

~~~
gambiting
So should we pay millions of dollars to any company that claims they have a
vaccine to Ebola, just because they say they do? It's not free - so we can't
just mass produce whatever miracle drug someone claims to have and keep our
fingers crossed that it works.

~~~
Maxious
We can't? [http://www.macleans.ca/society/health/canadas-
questionable-t...](http://www.macleans.ca/society/health/canadas-questionable-
tamiflu-stockpile/) [http://www.webmd.boots.com/cold-and-
flu/news/20140103/govern...](http://www.webmd.boots.com/cold-and-
flu/news/20140103/government-criticised-for-stockpiling-tamiflu)

~~~
evan_
So your argument is that two wrongs make a right?

------
pjkundert
"A chimpanzee cold virus was modified to carry Ebola genetic material
conferring protection against the Zaire strain of Ebola."

What could possibly go wrong!

~~~
gus_massa
I don't have access to the complete article, so I have to guess. The virus
have many parts. They probably copy one of the proteins of the surface of the
Ebola virus in the flu virus, not the main infectious code. So it "looks" like
an Ebola virus, but acts like a flu virus and only give you a mild flu.

~~~
hga
The containing Wikipedia article the chimpanzee virus was attenuated, and that
it doesn't replicate in humans, evidently either from that, or the
modification
([https://en.wikipedia.org/wiki/Ebola_vaccine#cAd3-EBO_Z](https://en.wikipedia.org/wiki/Ebola_vaccine#cAd3-EBO_Z)).

------
toyg
Looks like I was right:
[https://news.ycombinator.com/item?id=8411674](https://news.ycombinator.com/item?id=8411674)
\-- not even two months, and we're almost there.

Pharma research tends to speed up when diseases stop being "the poor's own
problem".

~~~
jonas21
This clinical trial was run in August, before anyone had contracted Ebola
outside of Africa (and before the comment you linked to).

