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So let's go through
the global clinical pipeline
of TB vaccine candidates.
So 15 years ago, there were
essentially no TB vaccines
in the clinic, and due to
stimulation of the field,
mostly through large grants
by the EC, European Community,
and the Bill and Melinda
Gates Foundation,
there has been huge work and
appreciation for the need
to develop tuberculosis vaccines.
And today we have a
relatively rich pipeline.
However, this pipeline
is somewhat lacking
in terms of its
immunologic diversity,
and we'll go through
that in a second.
The pipeline includes,
as you see in sort of purple,
the mycobacterial whole cell
extracts, the most advanced
of which is a non-tuberculosis
Mycobacterium, similar to TB,
which is in a Phase III
trial in rural China.
That's being studied in latency
patients, that is, patients who
have already been infected
with TB to try to keep them
from going on to either reactivating
or going on to active tuberculosis.
And that is a large Phase III
trial in 10,000 people which
should read out sometime in 2016.
There have been Phase IIB
trials, one of MVA85A,
which I'll talk about
shortly, as well
as an ongoing Phase IIB trial of
M72, a protein adjuvanted subunit.
There are protein adjuvants which
tend to dominate this in dark blue,
and those are subunit vaccines
containing somewhere between two
to four antigens, which are
always adjuvanted and given
usually by intramuscular injection.
And then there are the actual
mycobacterial vaccines themselves,
such as MTBVAC,
an actual attenuated vaccine.
So this is actually a live
attenuated tuberculosis,
which is being given intradermally,
developed by BIOFABRI
and the University
of Zaragoza in Spain.
We have DAR-901, which is another
non-tuberculosis mycobacteria
named Mycobacterium obuense.
We have RUTI, which is a whole
cell mycobacterial lysate.
And then we have a variety of viral
vectors shown in light purple,
such as the MV85A, which
is no longer advancing,
the Crucell Ad35, human
Ad35, expressing three antigens.
There is an intranasal flu
developed by the Russians.
There is an Ad5 that is
being developed to be given
as an aerosol vaccine by
the Chinese and CanSino,
as well as a recombinant BCG,
VPM1002, originally developed
by Stefan Kaufmann at the Max
Planck Institute in Germany,
and now being further developed
after being turned over
from the Vaccine Project
Management Organization in Germany
over to the Serum Institute of
India for further development.
