SIVS Basic and Non-clinical Vaccine Development
The Sealy Institute for Vaccine Sciences (SIVS)
strives to create, perfect and promote the most effective and safest
disease prevention strategies. However, to take a vaccine from the
discovery phase to the marketplace requires a few steps in between.
Before vaccines can be tested in human clinical trials, researchers must
do preclinical testing for safety and efficacy. In addition, vaccines
for many biodefense and emerging infectious disease pathogens may be
approved in the United States under the alternative "Animal Rule"
pathway, where pivotal efficacy studies in relevant animal models
replace traditional phase III efficacy trials in humans.
SIVS has experience with basic research and nonclinical development and
testing, and has internationally-recognized expertise in emerging and
neglected infectious diseases. The SIVS also has excellent resources and
access to UTMB’s many core facilities. The SIVS can assist scientists
and vaccine developers with:
- In vitro and in vivo
research and development of biologically relevant animal models and
supporting assays to study multiple infectious and non-infectious
- Development and evaluation of new adjuvants and novel vaccine platforms
- Immunogenicity testing and in vitro antiviral screening using high-throughput robotic equipment
- Preliminary safety and toxicology studies in a variety of test systems
studies for animal model qualification and vaccine efficacy testing for
Animal Rule approvals in accordance with a quality system based on the
principles of Good Laboratory Practices (GLP) for Nonclinical Laboratory
Studies (21 CFR Part 58)
has research infrastructure available in state-of-the-art ACL2/3,
BSL2/ABSL2, BSL3/ABSL3, and BSL4/ABSL4 capacity and aerosol challenge
facilities. The SIVS welcomes collaborations with individual
investigators, companies and government agencies, both locally and
In addition, the SIVS currently collaborates with UTMB's Center for Addiction Research and the Mitchell Center for Neurodegenerative Diseases to foster
development of vaccines for prevention and treatment of chronic non-infectious
diseases such as cocaine addiction and Alzheimer's disease.