The Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Research and Development Command played a key role in U.S. Government’s COVID-19 pandemic response. For more than 125 years, WRAIR has been a leader in global efforts to combat the world’s most pervasive and high impact infectious diseases, such as malaria, HIV/AIDS, Ebola, and dengue. The Institute played a key role in the development of many vaccines including ones for Adenovirus, influenza, dengue, typhoid, Hepatitis A and B, and Japanese encephalitis. In the early days of the COVID-19 pandemic, WRAIR infectious disease specialists quickly pivoted to spearhead countermeasure development efforts within the DoD and work in coordination with U.S. Government and private industry collaborators to develop tools to prevent, detect and treat COVID-19.
WRAIR experts partnered with researchers at other U.S. Government agencies and helped provide leadership for the oversight of vaccine development efforts for COVID-19. Subject matter experts at WRAIR joined Federal efforts early in the pandemic, providing critical expertise and guidance to the efforts that then fell under Operation Warp Speed and participated on White House Task Forces and product development teams for candidate COVID-19 vaccines. WRAIR’s unique strengths in clinical research, specifically around community engagement, clinical trial design and immune monitoring laboratory assays, helped guide tremendous efforts to develop and test novel vaccines, diagnostics and therapeutics.
As the epidemic evolved, WRAIR also contributed knowledge about the ongoing genetic diversity of the virus and the potential impacts of virus variability on the vaccines in use and in development. In addition to their contributions to the Federal effort, WRAIR scientists worked closely with industry and U.S. Government partners to develop a “pan-coronavirus” vaccine technology that may potentially offer safe, effective and durable protection against evolving variants of concern and similar coronaviruses that could emerge in the future. This effort to create a broader, forward-thinking strategy was complementary to the landscape of global countermeasures that were developed while fulfilling WRAIR’s mission to protect Service members and the global community from the increasing threat posed by emerging infectious diseases.
WRAIR scientists took a long-term, strategic approach by mapping and optimizing the SARS- CoV-2 surface protein structure for presentation on a nanoparticle scaffold, a technology based on approaches developed for an influenza vaccine by the National Institutes of Health. Different from licensed mRNA and adenovirus vector vaccines currently in use, the WRAIR’s SpFN (Spike Ferritin Nanoparticle) candidate vaccine is a recombinant protein subunit nanoparticle vaccine that presents a fragment of the virus to the immune system to elicit a protective response. Ferritin is a naturally occurring iron- carrying protein that self-assembles into spherical cage.
Researchers hypothesize that presenting multiple copies of Spike in an ordered array may be a key to inducing a potent and broadly protective immune response. SpFN is different than the recently authorized protein nanoparticle developed by Novavax in that it produces a more highly ordered nanoparticle. The SpFN vaccine is formulated with ALFQ, one of the Army Liposome Formulation family of adjuvants developed by researchers at WRAIR. An adjuvant is a component of a vaccine that helps activate the immune system and improve immune responses.
Preclinical and early clinical studies have demonstrated ALFQ to be safe and strongly potent as a vaccine adjuvant. Pre-clinical animal studies of SpFN show the candidate vaccine not only elicits a potent immune response but may also provide broad protection against SARS-CoV-2 variants of concern, as well as other human and zoonotic coronaviruses. SpFN entered Phase 1 human trials in April 2021. The findings generated by this trial, expected to be published in late 2022, will provide key insights into SpFN’s potency, breadth and durability in humans. The results will also allow the broader community of researchers to compare SpFN’s immune profile to that of other COVID-19 vaccines already in use.
For more information, see:
https://www.wrair.army.mil/biomedical-research/emerging-infectious-diseases