Welcome to the Vaccine Clinical Trials Program

The Sealy Institute for Vaccine Sciences (SIVS) Clinical Trials Program has been in existence since 2002. Our investigators, research nurses and coordinators are experienced in all phases of vaccine clinical trials from first-in-human Phase I studies through Phase IV post-marketing studies. Study populations have included premature infants, infants and toddlers, children, adolescents, adults and the elderly.

Clinical trials are the final step in the vaccine development process. The purpose of the SIVS Clinical Trials Program is to conduct these clinical trials, providing the necessary data on vaccine efficacy, immunogenicity and safety in humans.

Below is an overview of the various vaccines for which the SIVS Clinical Trials Program has conducted studies.

Overview of Vaccine Clinical Trial Experience

Pediatric

Phase I/II
Pneumococcal
RSV
mRNA (hMPV/PIV3)

Phase II
Meningococcal B
CMV
Influenza (H1N1)
Influenza /seasonal
Pneumococcal

Phase III
HSV
Meningococcal ACWY
MMR/MMRV/Varicella
Rotavirus
Human papillomavirus
Infant Combination
Pneumococcal

Phase IV
Rotavirus
Meningococcal ACWY

Adult

Phase I
CMV
Influenza (H5N1)
Influenza (H5N8)
Influenza (Universal)
Dengue
Smallpox

Phase 1/2
SARS-CoV-2

Phase II
CMV
Influenza (H7N9)
Influenza (Seasonal)
Pneumococcal
mRNA-SARS-CoV-2

Phase III
Meningococcal ACWY
Varicella zoster
Human papillomviruse
Ebola
RSV
Clostridium difficile

Older Adult

Phase I
CMV

Phase I-II
Pneumocococcal

Phase II
Influenza (H7N9)
Influenza (Seasonal)

Phase III
Varicella zoster

Other Clinical Trial Experience

Pediatric

Phase I/II
Monoclonal antibody for prevention of RSV infection

Phase II/III
Monoclonal antibody for prevention of Staphylococcal sepsis

Adult/Older Adult

Phase I/II
Monoclonal antibody therapy for treatment of influenza A

Phase III
Treatment of Non-hospitalized Subjects with Influenza A infection

Adaptive
Treatment of COVID-19 in Hospitalized Adults

Treatment of Outpatients with COVID-19

Expanded Access
Treatment for Patients with Ebola Virus Disease