A SARS-CoV-2 Spike Ferritin Nanoparticle Vaccine Is Protective and Promotes a Strong Immunological Response in the Cynomolgus Macaque Coronavirus Disease 2019 (COVID-19) Model

Sara C Johnston; Keersten M Ricks; Ines Lakhal-Naouar; Alexandra Jay; Caroline Subra; Jo Lynne Raymond; Hannah A D King; Franco Rossi; Tamara L Clements; David Fetterer; Samantha Tostenson; Camila Macedo Cincotta; Holly R Hack; Caitlin Kuklis; Sandrine Soman; Jocelyn King; Kristina K Peachman; Dohoon Kim; Wei-Hung Chen; Rajeshwer S Sankhala; Elizabeth J Martinez; Agnes Hajduczki; William C Chang; Misook Choe; Paul V Thomas; Caroline E Peterson; Alexander Anderson; Isabella Swafford; Jeffrey R Currier; Dominic Paquin-Proulx; Linda L Jagodzinski; Gary R Matyas; Mangala Rao; Gregory D Gromowski; Sheila A Peel; Lauren White; Jeffrey M Smith; Jay W Hooper; Nelson L Michael; Kayvon Modjarrad; M Gordon Joyce; Aysegul Nalca; Diane L Bolton; Margaret L M Pitt

doi:10.3390/vaccines10050717

A SARS-CoV-2 Spike Ferritin Nanoparticle Vaccine Is Protective and Promotes a Strong Immunological Response in the Cynomolgus Macaque Coronavirus Disease 2019 (COVID-19) Model

Vaccines (Basel). 2022 May 4;10(5):717. doi: 10.3390/vaccines10050717.

Authors

Sara C Johnston¹, Keersten M Ricks², Ines Lakhal-Naouar^{3

4}, Alexandra Jay⁵, Caroline Subra^{3

6

7}, Jo Lynne Raymond⁸, Hannah A D King^{3

6

7}, Franco Rossi⁵, Tamara L Clements², David Fetterer⁵, Samantha Tostenson⁹, Camila Macedo Cincotta^{3

4}, Holly R Hack^{3

4}, Caitlin Kuklis¹⁰, Sandrine Soman¹⁰, Jocelyn King¹⁰, Kristina K Peachman⁴, Dohoon Kim^{3

6}, Wei-Hung Chen^{3

7}, Rajeshwer S Sankhala^{3

7}, Elizabeth J Martinez^{3

7}, Agnes Hajduczki^{3

7}, William C Chang^{3

7}, Misook Choe^{3

7}, Paul V Thomas^{3

7}, Caroline E Peterson^{3

7}, Alexander Anderson^{3

6

7}, Isabella Swafford^{3

6

7}, Jeffrey R Currier¹⁰, Dominic Paquin-Proulx^{3

6

7}, Linda L Jagodzinski⁴, Gary R Matyas⁶, Mangala Rao⁶, Gregory D Gromowski¹⁰, Sheila A Peel⁴, Lauren White⁵, Jeffrey M Smith¹, Jay W Hooper¹, Nelson L Michael¹¹, Kayvon Modjarrad⁷, M Gordon Joyce^{3

7}, Aysegul Nalca¹², Diane L Bolton^{3

6

7}, Margaret L M Pitt¹³

Affiliations

¹ Virology Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
² Diagnostic Systems Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
³ Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD 20817, USA.
⁴ Diagnostics and Countermeasures Branch, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
⁵ Veterinary Medicine Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
⁶ U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
⁷ Emerging Infectious Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
⁸ Pathology Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
⁹ Core Laboratory Services Division, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
¹⁰ Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
¹¹ Center for Infectious Diseases Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
¹² Core Support Directorate, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.
¹³ Office of the Science Advisor, United States Army Medical Research Institute of Infectious Diseases, Frederick, MD 21702, USA.

Abstract

The COVID-19 pandemic has had a staggering impact on social, economic, and public health systems worldwide. Vaccine development and mobilization against SARS-CoV-2 (the etiologic agent of COVID-19) has been rapid. However, novel strategies are still necessary to slow the pandemic, and this includes new approaches to vaccine development and/or delivery that will improve vaccination compliance and demonstrate efficacy against emerging variants. Here, we report on the immunogenicity and efficacy of a SARS-CoV-2 vaccine comprising stabilized, pre-fusion spike protein trimers displayed on a ferritin nanoparticle (SpFN) adjuvanted with either conventional aluminum hydroxide or the Army Liposomal Formulation QS-21 (ALFQ) in a cynomolgus macaque COVID-19 model. Vaccination resulted in robust cell-mediated and humoral responses and a significant reduction in lung lesions following SARS-CoV-2 infection. The strength of the immune response suggests that dose sparing through reduced or single dosing in primates may be possible with this vaccine. Overall, the data support further evaluation of SpFN as a SARS-CoV-2 protein-based vaccine candidate with attention to fractional dosing and schedule optimization.

Keywords: Army Liposomal Formulation QS-21; COVID-19; SARS-CoV-2; SpFN; aluminum hydroxide; ferritin nanoparticle; primate; vaccine.

Grants and funding

Funding for this effort was provided by the Military Infectious Diseases Research Program under project number 341155776. Additionally, this work was supported by a cooperative agreement (W81XWH-18-2-0040) between the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. and the U.S. Department of Defense (DOD), and was supported in part by the US Army Medical Research and Development Command under contract number W81-XWH-18-C-0337. Funding for this effort was provided by the Military Infectious Diseases Research Program under project number 150155790.