Clinical trials for the first dry
powder measles vaccine are
scheduled to begin in March
2010 in India. The new vaccine
– a dry powder that can be
inhaled directly into the lungs
– is likely to be more effective
as it mimics the natural route of
the infection and has given the
Indian government hope in the
fight against the disease, which
kills more than 200,000 children
each year.
The vaccine is being
developed by Robert Sievers
from the University of Colorado,
US, and the Serum Institute of
India (SII), Pune. If the vaccine
passes safety and efficacy
tests, the Pune-based vaccine
manufacturer is looking at
a demand of 400m doses of
measles vaccine annually.
‘We are waiting for regulatory
permissions and will start the trials
around the end of March next
year. So far, the vaccine has been
effective on animal models. The
animal studies are ongoing but
we already know that when the
vaccine is inhaled and goes directly
to the lungs, the immune response
is better,’ said additional medical
director, SII, Prasad Kulkarni, who
will be heading the research team.
The institute will conduct human
trials next year with 30 adults to
test the vaccine’s effectiveness.
Besides being safe and painfree,
the dry powder inhalable
measles vaccine, if found to be as
effective as the vaccine currently
in use, will eliminate the risks
associated with the use of poorly
sterilised needles. ‘In developing countries, we require vaccines,
which can be stable outside the
cold chain.
Being safe and pain-free work
in favour of the new vaccine, but
what is more significant is that the
new vaccine will eliminate the risk of
spreading HIV or hepatitis from dirty
needles. If the trials are successful,
countries like India, which seriously
lack proper cold chain facilities, will
greatly benefit from this vaccine as
it is likely to increase the coverage
under the national vaccination
programme,’ said Sushil Kabra,
paediatric pulmonologist, All India
Institute of Medical Sciences.
The vaccine is prepared by
mixing a weakened measles virus
with supercritical carbon dioxide
to produce microscopic bubbles
and droplets, which dry into an
inhalable powder. The powder
is puffed into a small, cylindrical
plastic sack, with an opening like
the neck of a plastic water bottle,
and administered nasally.
‘We will be comparing two
models for packaging of the
vaccine. Both are simple devices
but will be studied in greater
detail during the clinical trials
and compared,’ says Kulkarni. He
added that the vaccine should be
on the market by 2013 if all goes
to plan.
According to the Indian Ministry
of Health and Family Welfare, almost
25m Indian children received measles
vaccines in the last three years, with
16m of those vaccinated in 2008
alone. The disease kills about 500
children every day, and only 66%
of children, less than 50% in some
states, receive vaccinations.