For Sponsors - An Overview

The Sealy Institute for Vaccine Sciences (SIVS) Clinical Trials Program is a comprehensive vaccine clinical trials program, with a large portfolio of both government and industry-sponsored trials, covering the spectrum from first time in human Phase I trials through Phase IV post-marketing studies.

The University of Texas Medical Branch

Located on the island of Galveston 50 miles south of Houston, UTMB offers sponsors the advantages associated with an academic health center, including:

  • Electronic medical records
  • Clinical laboratory services
  • Investigational pharmacy
  • Office of Research Subject Protections & IRB
  • In-patient and out-patient facilities

With 693,930 outpatient visits, 40,260 ER visits, 25,444 hospital admissions, and 5,381 births (FY 2013) the SIVS Clinical Trials Group has access to patients with specific disease conditions as well as plenty of healthy volunteers.

SIVS Clinical Trials Program

  • Investigators with a particular interest in vaccines
  • Research nurses/coordinators are CCRP and IATA certified
  • Experienced in all aspects of clinical trials
  • Successful recruitment strategies
  • High retention rates (>95%)
  • Focus on protocol compliance and data integrity
  • Meet Good Clinical Practice standards

Our Facilities

  • Two locations - Galveston and League City
  • Both sites have a dedicated clinical trial laboratory for study product storage, sample processing and storage
  • Triage room
  • Examination rooms
  • Offices and storage space 

Our Volunteers

  • Good relationships with our volunteers are fundamental to our success
  • >2,400 volunteers recruited since 2002
  • Ages range from infants to the elderly
  • Demographics - approximately 40% Caucasian, 30% Black, 30% Hispanic
  • Volunteer registry available

Our Sponsors

  • Large pharmaceutical companies
  • NIAID DMID Vaccine Treatment and Evaluation Unit (Subcontractor)
  • NICHD Pediatric Trials Network
  • Small biotech companies

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