Ongoing Clinical Trials
A Study of Pneumococcal Conjugate Vaccine Compared
to a Marketed Vaccine
Please click here or contact Lori Simon at 409-747-9240 for further information
Cytomegalovirus (CMV) Vaccine Study for Teenage Girls
Please contact Gerianne Casey at (409) 772-1696
What Are Clinical Trials?
When a new vaccine or drug is developed, it is important that
it is tested in humans for both safety and effectiveness. Studies
performed on humans are known as clinical trials. The operation
of clinical trials is complex and is regulated by the Food and Drug
Administration (FDA). Usually, the process starts with testing the
safety in a small number of healthy adults. Once shown to be safe in
this group, the vaccine or drug is tested for effectiveness and safety
in a much larger group, usually adults. If successful, clinical
trials are then conducted in targeted vulnerable populations such as
children and the elderly. The FDA may license the vaccine or drug
based on positive safety and efficacy data generated from the trials.
Clinical trials may continue even after licensure to further
demonstrate safety and effectiveness.
More information about Clinical Trials and answers to commonly asked questions, are available at ClinicalTrials.gov.
The Department of Pediatrics and Clinical Trials
Many Department of Pediatrics Faculty play an important role in
clinical trials. Our utmost concern is for the safety of the infants,
children and teens involved in the studies. The work done in our
department has helped in the FDA licensure of vaccines that are now
commonly given and help prevent death and illness in children every
day. In addition, other recent highlights include work with
antibiotics, antivirals, sepsis (severe life-threatening infections)
and cancer treatments.
Janak Patel, MD
Judith Rowen MD
Richard Rupp MD
Karen Shattuck, MD
The Office of Pediatric Clinical Trials
The Office of Pediatric Clinical Trials has experience
performing studies sponsored by either the Centers for Disease Control
and Prevention, National Institute of Allergy and Infectious
Diseases, or drug companies. The Office is a component of the UTMB
Sealy Center for Vaccine Development. The Office of Pediatric
Clinical Trials has a large portfolio of studies performed at all
phases from the very first-testing-in-humans through post-licensure.
The goal is to offer excellent service from the viewpoint of both the
participant and the sponsor. Staff and investigators focus on
presenting balanced information to insure that the informed consent
process is precise, informative and interactive. They are very
committed to assuring that subjects and their families fully
understand the project, its risks, benefits, expectations and