AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 8, Number 8, 1992 Mary Ann Liebert, Inc., Publishers
International Vaccine
Efficacy Trials: Special Considerations DONALD S. BURKE
INTRODUCTION
complicated International demanding. along groundwork high convergent paths. (1) study population vaccine
field trials
Downloaded by Iowa State Univ from www.liebertpub.com at 01/12/19. For personal use only.
Meticulous
are
and
must be done
with a several A incidence of infection must be defined and monitored, and the specific immunotype(s) of variants in this population must be regularly sampled and analyzed. (2) A safe approved vaccine with a good probability of success against the prevalent immunotype(s) must be available. Animal model experiments should confirm that the specific vaccine to be field tested protects against (and does not enhance) the specific field isolates of the prevalent immunotype. (3) An on-site field technical infrastructure must already exist or it must be developed. A host country institution may have to be strengthened to develop trained personnel, facilities, and equipment for each of the following areas:
handling/storage, laboratory, data processing, and administrative. (4) Apolitical infrastructure for the vaccine trial must also already exist or it must be developed. Mechanisms must be defined for communication, spheres of responsibility and authority, long-term obligations, and legal and ethical oversight. Professional diplomats and politicians (USA, WHO) can help harmonize the interests of the affected study population, vaccine manufacturer, medical research team, and host nation authori-
ties.
clinical, epidemiológica!, sociobehavioral, specimen
Walter Reed
Army Institute of Research.
13 Taft Court, Rockville, MD 20850.
1531
Address
reprint requests
to:
David S. Burke Walter Reed Army Institute of Research 13 Taft Court Rockville, MD 20850
International Vaccine
Efficacy Trials: Special Considerations DONALD S. BURKE
INTRODUCTION
complicated International demanding. along groundwork high convergent paths. (1) study population vaccine
field trials
Downloaded by Iowa State Univ from www.liebertpub.com at 01/12/19. For personal use only.
Meticulous
are
and
must be done
with a several A incidence of infection must be defined and monitored, and the specific immunotype(s) of variants in this population must be regularly sampled and analyzed. (2) A safe approved vaccine with a good probability of success against the prevalent immunotype(s) must be available. Animal model experiments should confirm that the specific vaccine to be field tested protects against (and does not enhance) the specific field isolates of the prevalent immunotype. (3) An on-site field technical infrastructure must already exist or it must be developed. A host country institution may have to be strengthened to develop trained personnel, facilities, and equipment for each of the following areas:
handling/storage, laboratory, data processing, and administrative. (4) Apolitical infrastructure for the vaccine trial must also already exist or it must be developed. Mechanisms must be defined for communication, spheres of responsibility and authority, long-term obligations, and legal and ethical oversight. Professional diplomats and politicians (USA, WHO) can help harmonize the interests of the affected study population, vaccine manufacturer, medical research team, and host nation authori-
ties.
clinical, epidemiológica!, sociobehavioral, specimen
Walter Reed
Army Institute of Research.
13 Taft Court, Rockville, MD 20850.
1531
Address
reprint requests
to:
David S. Burke Walter Reed Army Institute of Research 13 Taft Court Rockville, MD 20850
