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Principal Investigator: Oreola Donini
Organization: SOLIGENIX, INC.
Fiscal Year: 2022
Award: $829,746
Funding agency: National Institute of Allergy and Infectious Diseases
7. Project Summary/Abstract
The proposal requests funding to support manufacturing and immune characterization of a novel, emulsified
adjuvant which is uniquely compatible with lyophilization strategies to enable thermostabilization of
glycoprotein vaccines. The major objectives of the study are to transfer and optimize the manufacture of a
novel adjuvant and to characterize and assess the comparative immunogenicity of different adjuvant
formulations in terms of both humoral and cell mediated immunity, utilizing two different multimeric glycoprotein
antigens. Ultimately, this program will identify an optimal adjuvant formulation, capable of potentiating both
humoral and cell mediated immunity to protein antigens, compatible with lyophilization and resulting in a
thermostabilized vaccine utilizing Generally Regarded as Safe (‘GRAS’) excipients. Specific formulation
development will be done in the context of the Zaire ebolavirus (EBOV) GP, a component of our trivalent
filovirus vaccine (TriFiloVax) targeting EBOV, Sudan ebolavirus (SUDV) and marburgvirus (MARV) and with
SAR-CoV-2 spike protein, supporting COVID-19 vaccine development efforts. While state of the art medical
treatment may increase the chances of survival of both the highly fatal EBOV and the highly transmissible
COVID-19, currently no antiviral therapy is available to prevent or cure the disease. Vaccination remains the
most feasible route for addressing and preventing future epidemics. Ongoing clinical development in the
context of EBOV has identified both therapeutics and vaccines which are being tested in the ongoing outbreak
in the Democratic Republic of Congo. However, these approaches are highly selective for EBOV only. The sole
approved vaccine is a virally vectored vaccine requiring cold storage (<-60°C) storage / distribution and also
cannot be used in at-risk populations showing any signs of immunodeficiency or in pregnant women and is
potentially more variable in less responsive populations. These vaccine platforms also may not be used
repeatedly (either as boosters or with other protein antigens) because of the humoral induced immunity to the
viral platform which occurs with vaccination. There is no vaccine for MARV, SUDV or COVID-19. In contrast,
subunit vaccines offer many advantages, including improved safety, compatibility with immunosuppressed,
immunocompromised or high risk populations or those who have previously received virally vectored vaccines.
Thermostabilized formulations also facilitate stockpiling and emergency use in logistically challenging
environments. The specific aims of the proposal include to i) transfer manufacturing methods and manufacture
engineering lots of CoVaccine with varying Polysorbate 80 content and ii) characterize the enhancement of
both humoral and cell mediated immunity by CoVaccine HT™ with SARS-CoV-2 Spike protein and EBOV GP,
thereby facilitating the development of TriFiloVax (for EBOV, MARV and SUDV) and CiVax (for COVID-19) and
more generally for other protein vaccines.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV S protein><2019-nCoV spike glycoprotein><2019-nCoV spike protein><2019-nCoV vaccine><Address><Adjuvant><Alum Adjuvant><Animal Model><Animal Models and Related Studies><Antibody titer measurement><Antigens><Antiviral Therapy><Assay><Attenuated><Awareness><Belgian Congo><Bioassay><Biologic Assays><Biological Assay><COVID-19><COVID-19 S protein><COVID-19 spike glycoprotein><COVID-19 spike protein><COVID-19 vaccine><COVID-19 virus><COVID19><COVID19 S protein><COVID19 spike glycoprotein><COVID19 spike protein><COVID19 vaccine><COVID19 virus><CV-19><CV19><Care Givers><Caregivers><Caring><Cavia><Cell Body><Cell Mediated Immunology><Cell Surface Glycoproteins><Cell-Mediated Immunity><Cells><Cellular Immunity><Cessation of life><Clinical Research><Clinical Study><Clinical Trials><CoV-2><CoV2><Coronaviridae><Coronavirus><Coupled><Cryofixation><Cryopreservation><Death><Democratic Republic of the Congo><Development><Disease><Disease Outbreaks><Disease model><Disorder><EBOV><Early-Stage Clinical Trials><Ebola virus><Ebola-like Viruses><Elderly><Emergencies><Emergency Situation><Engineering><Environment><Epidemic><Excipients><Family><Family member><Filoviridae><Filoviridae Infections><Filovirus><Flow Cytofluorometries><Flow Cytofluorometry><Flow Cytometry><Flow Microfluorimetry><Flow Microfluorometry><Formulation><Frankfurt-Marburg Syndrome Virus><Freeze Drying><Freeze Dryings><Funding><Future><GPI-0100><GPI0100><Glycoproteins><Guinea Pigs><Guinea Pigs Mammals><Hawaii><Human><Humoral Immunities><Immune><Immune response><Immunes><Immunity><Immunize><Immunocompromised><Immunocompromised Host><Immunocompromised Patient><Immunodeficiency Disorder><Immunodeficiency Syndrome><Immunologic Deficiency Syndromes><Immunological Deficiency Syndromes><Immunological response><Immunosuppressed Host><Infection><Insecta><Insects><Insects Invertebrates><Joints><Light><Logistics><Lyophilization><MERS corona virus><MERS coronavirus><MERS virus><MERS-CoV><Marburg><Marburg virus><Marburg-like Viruses><Marburgvirus><Mediating><Medical><Medical Staff><Membrane Glycoproteins><Metabolic Glycosylation><Methods><Mice><Mice Mammals><Middle East Respiratory Syndrome Corona Virus><Middle East Respiratory Syndrome Coronavirus><Middle East Respiratory Syndrome Virus><Middle East Respiratory Syndrome-CoV><Middle Eastern Respiratory Syndrome Corona virus><Middle Eastern Respiratory Syndrome Coronavirus><Middle Eastern Respiratory Syndrome Virus><Middle Eastern Respiratory Syndrome-CoV><Modern Man><Murine><Mus><Outbreaks><Particle Size><Phase><Phase 1 Clinical Trials><Phase 2 Clinical Trials><Phase I Clinical Trials><Phase II Clinical Trials><Photoradiation><Polysorbate 80><Population><Populations at Risk><Pregnant Women><Procedures><Property><Proteins><Public Health><Recombinants><Request for Proposals><Research><Risk><Route><SARS Virus><SARS corona virus><SARS corona virus 2><SARS coronavirus><SARS-Associated Coronavirus><SARS-CO-V2><SARS-COVID-2><SARS-CoV><SARS-CoV-1><SARS-CoV-2><SARS-CoV-2 S protein><SARS-CoV-2 spike glycoprotein><SARS-CoV-2 spike protein><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 S protein><SARS-CoV2 spike glycoprotein><SARS-CoV2 spike protein><SARS-CoV2 vaccine><SARS-Related Coronavirus><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><SUDV><Safety><Severe Acute Respiratory Coronavirus><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome Virus><Severe Acute Respiratory Syndrome corona virus><Severe Acute Respiratory Syndrome coronavirus><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 S protein><Severe acute respiratory syndrome coronavirus 2 spike glycoprotein><Severe acute respiratory syndrome coronavirus 2 spike protein><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Structure><Subunit Vaccines><Sudan Ebola virus><Sudan ebolavirus><Sudan virus><Surface Glycoproteins><Symptoms><System><Testing><Therapeutic><Time><Transformed Cell Line><Universities><Vaccination><Vaccines><Viral><Viral Diseases><Viral Hemorrhagic Fevers><Viral Vector><Virulence><Virus><Virus Diseases><Work><Wuhan coronavirus><ZEBOV><ZIKV><Zaire><Zaire Ebola virus><Zaire ebolavirus><Zika Virus><advanced age><alum><aluminum sulfate><anti-viral therapy><antibody titering><antibody-based immunity><cell mediated immune response><clinical development><cold preservation><cold storage><comparative><corona virus><corona virus disease 2019><corona virus disease 2019 vaccine><coronavirus disease 2019><coronavirus disease 2019 S protein><coronavirus disease 2019 spike glycoprotein><coronavirus disease 2019 spike protein><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus disease-19 virus><coronavirus infectious disease-19><cost effective><develop a vaccine><develop vaccines><development of a vaccine><developmental><disorder model><ebolavirus><elders><expectant mother><expecting mother><filovirus infections><flow cytophotometry><geriatric><glycosylation><hCoV19><hemorrhagic fever><high risk group><high risk population><host response><hypoimmunity><immune deficiency disorder><immune system response><immunodeficiency><immunogen><immunogenicity><immunoresponse><immunosuppressed><immunosuppressed patient><improved><late life><later life><medical countermeasure><model of animal><model organism><mortality><mouse model><murine model><nCoV2><neutralizing antibody><non-human primate><nonhuman primate><novel><older adult><older person><phase I protocol><phase II protocol><plasmid vaccine><pregnant mothers><prevent><preventing><programs><recombinant virus><response><senior citizen><severe acute respiratory syndrome-CoV><success><thermolability><thermostability><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine candidate><vaccine development><vaccine for novel coronavirus><vaccine formulation><vaccine platform><vector vaccine><viral infection><viral infectious disease treatment><virus infection><virus-induced disease><zikav>