2011 - Cooperative Institute for Research in Environmental Sciences ...

Robert Sievers
Innovative Vaccine Delivery Methods for
Disease Control in Warm Climates
FUNDING: FOUNDATION FOR THE NATIONAL INSTITUTES OF
HEALTH (FNIH); FOUNDATION FOR THE NIH IN THE BILL AND
MELINDA GATES FOUNDATION’S GRAND CHALLENGES IN
GLOBAL HEALTH INITIATIVE; AKTIV-DRY, LLC; MONTANA STATE
UNIVERSITY; CIRES INNOVATIVE RESEARCH GRANT
Increased stability and safety of aerosol, needle-free,
inhalable vaccines are goals of the CIRES team effort in
Global Health. Efficacy of generating a protective immune
response in test animals by inhalation of a measles virus
vaccine has been published in Proceedings of the National
Academy of Sciences. We have demonstrated that the powder
formulation is stable and satisfies the World Health Organization’s
short-term stability requirement at 37°C. It also
possesses good stability characteristics over a much longer
period (less than 1 log loss of potency after more than three
years storage at 2–8°C). In addition, CIRES’ collaborators in
Pune, India, have established room-temperature stability of
our dry powder aerosol vaccine for six months.
Final approval from the Indian regulatory authority
50 CIRES Annual Report 2011
(DCGI) to begin Phase I clinical trials in human volunteers
is being awaited. The FNIH-supported Sievers team
from Aktiv-Dry LLC, CU-CIRES, the Serum Institute of
India, Sristek Private Ltd., Centers for Disease Control
and Prevention (CDC), Johns Hopkins University and
BD Technologies has made plans to begin subject recruitment.
The agency program manager at the Foundation
for the National Institutes of Health has acclaimed in the
media the team’s progress: “It has tremendous implications…It’s
remarkable to get this far in a relatively short
period of time.” Achievements include reformulating with
myo-inositol (a newly discovered stabilizer) an existing
measles vaccine as a potent live attenuated virus vaccine
and developing two inhalation devices for administering
the vaccine powder to children in the developing world.
CIRES patent applications have been submitted.
Sievers also accepted the invitation of Doctors Without
Borders to describe in a briefing at their Paris headquarters
the new results of hepatitis B vaccine stabilization,
packaging and delivery studies supported by the NIH
National Institute of Allergy and Infectious Diseases.
Subsequently, EpiCentre, the international pediatrics arm
of Doctors Without Borders, has proposed a cooperative
joint field and lab study utilizing vaccines and delivery
devices developed in Colorado. The recent resurgence
of measles and other diseases in Africa and higher death
rates make this a high-priority activity.
GLENN ASAKAWA
Bob Sievers, with help from his 11-year-old grandson, Benjamin Louis Sievers, demonstrates how vaccines can be delivered by inhaling from a bag.