PACHA Recommendations for Achieving the AIDS Vaccine Goal (Draft)

The NIH has an effective domestic network to
conduct small-scale, clinic-and hospital-based
preliminary (phase I and II) human trials of candidate
AIDS vaccines for safety and immune response, and has
successfully tested a number of such products. These
sites, however, are underutilized because there are not
sufficient candidate AIDS vaccines being developed for
human testing.
* NIH should continue to maintain its capacity
to conduct the early clinical phase I and II
trials of AIDS vaccines.
4. LARGE SCALE FIELD TRIALS
The AIDS vaccine development process is "stuck".
Candidate vaccines which have completed phase I and II
trials are not advancing to the definitive large-scale
(phase III) field trials to determine if they actually
will work to protect humans from HIV or AIDS. To
achieve the vaccine goal, multiple, simultaneous field
trials of various vaccine candidates will need to be
conducted concurrently, not waiting for the results of
one before starting others. Many such trials will
likely occur in developing countries, where the
incidence of new infection is much higher, and where
governments cannot afford expensive drug treatments
after infection occurs.
Agencies such as DOD and CDC have extensive
expertise in field epidemiology and disease surveillance
needed to conduct large-scale vaccine field trials,
especially in developing countries. DOD and CDC have
experience maintaining long-term overseas field research
infrastructures under government-to-government
institutional commitments that will be needed for the
long and repeated vaccine trials which may extend over
decades. The NIH funding paradigm which uses
U.S.-university-based researchers on short 3- and 5-year
grant cycles to conduct research with sister academic
institutions overseas is less suited for this purpose.
It's overseas network for AIDS vaccine trials organized
in 1990 has yet to conduct any NIH-sponsored clinical
vaccine studies.