We set research standards

Highly variable methodology in previous vaccine studies made valid comparison of vaccines’ safety profiles difficult if not impossible. Different researchers often used different definitions for AEFI such as “fever”, “encephalitis” and many other AEFI. Thus the significance (or lack thereof) of reported higher or lower AEFI rates after different vaccines or between trials of the same vaccine conducted at different research centers was uninterpretable. Variable case definitions of AEFI also made valid quantification of rare but serious AEFI nearly impossible. Brighton has addressed these issues by using its expert network, via web platforms and teleconferences, to develop standardized and validated AEFI case definitions.

ACCOMPLISHMENTS: 

  • Over 1000 participants from over 100 countries including experts in vaccines, pediatrics, infectious diseases and other specialties participate in our programs.
  • First structured standardization and validation of AEFI definitions improves comparisons between vaccines and between different clinical trials.
  • Innovative guidance for analysis and presentation of AEFI data increases completeness, comparability, and transparency of results.
  • First standardized safety sections of vaccine trial protocols enable state of the art safety data collection from clinical trial participants in both developed and developing nations, no matter where they live.
  • Innovative web-tools for AEFI reporting in rapid format, upgrading data quality by streamlining objective AEFI classification.

Case definitions of adverse events

Case Definitions are at the heart of epidemiologic research. We build multidisciplinary teams of volunteers with relevant expertise to create a common understanding of adverse events following immunization. Read more.

Guidelines for vaccine safety research

Comparability of data accross trials is key to adding value to the results of individual studies. Our guidelines propose a minimal common denominator for investigators to collect, analyze, and present data on adverse events following immunization. Read more.

Template research protocols

Precious few researchers fully grasp the epidemiologic nuances of protocol design. By using our templates, researchers leverage the most experienced minds in vaccine safety and make the results more transparent and comparable. Read more.

Viral Vector Templates

Research on viral vectors and their safety is a highly dynamic area. We develop and update profiles describing the key characteristics of each major viral vector in use for vaccine development, based on best available scientific evidence. Read more.