In 2014, as the Ebola outbreak escalated, NIAID collaborated with pharmaceutical company GlaxoSmithKline (GSK) on NIAID-planned clinical trials to test Ebola vaccine candidates. Their collaboration exemplifies the flexibility and creativity of the NIAID Technology Transfer and Intellectual Property Office (TTIPO), who developed unique and expedited agreements to facilitate the development of an Ebola vaccine.
Researchers at the NIAID Vaccine Research Center (VRC) had already been developing and testing Ebolavirus vaccine candidates for over 15 years. In 2008, a research collaboration agreement (RCA) allowed VRC to work with Okairos, a Switzerland-based biotechnology company specializing in vaccine platform technologies. Vaccine platforms are the ways in which a vaccine gets delivered to the immune system. The RCA provided the VRC with access to one of Okairos’ platforms, a chimpanzee adenovirus vector (cAd), to deliver the VRC’s candidate Ebolavirus (EBOV) glycoprotein gene, creating the cAd3-EBOV vaccine. The approach resulted in an effective immune response to EBOV glycoproteins in humans. NIAID researchers worked with Leidos Biomedical Research, Inc. scientists to manufacture the EBOV vaccine candidate in preparation of clinical trials aimed at testing safety in humans.
In 2013, GSK acquired Okairos and its RCA with NIAID, and in 2014, GSK and NIAID expanded upon the agreement to better respond to the Ebola outbreak. TTIPO worked on the time-sensitive agreements for this collaboration: Agreements were negotiated and executed at an accelerated pace to allow clinical studies to begin as soon as regulatory approval was granted. Unique agreements were drafted to circumvent anticipated delays that could have slowed the start of clinical trials, including a restrictive material transfer agreement (MTA) that was used to send cAd3-EBOV test particles to the clinical trials sites in the United Kingdom, enabling it to clear customs and make it to the clinical pharmacy within the planned timeframe for initiation of the clinical protocol.
This nimble work allowed the clinical trial to begin within hours of the execution of the clinical trial agreement, ensuring that no valuable time was lost. GSK continued the development of the cAd3-EBOV vaccine candidates in Phase II trials in Africa.
The Federal Laboratory Consortium for Technology Transfer (FLC) recognized NIAID with an Excellence in Technology Transfer Award for their work on unique and expedited agreements needed for Ebola vaccine development after the 2014 Ebola outbreak. Congratulations to Nancy Sullivan, Vincent Feliccia, Carol Salata, Amy Petrik, Judy Stein, Rosemary Walsh, and Claudia Haywood (Leidos) for this recognition.
The West African Ebola virus epidemic (2013–2016) was the most widespread outbreak of Ebola virus disease (EVD) in history—causing major loss of life and socioeconomic disruption in the region, mainly in the countries of Guinea, Liberia, and Sierra Leone.
Published courtesy of the National Institute of Allergy and Infectious Diseases