Abstract

The novel SARS-CoV-2 is the cause of the coronavirus (CoV) disease (COVID-19) outbreak that currently pose a serious pandemic threat to public health. A safe vaccine that rapidly induces long-lasting virus-specific immune responses is urgently needed. The CoV spike (S) protein, a characteristic structural component of the viral envelope, is considered a key target for vaccines against CoV infection, as we and others have previously demonstrated for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS) CoV infections. The safety profile of non-infectious recombinant protein subunit vaccines makes them suitable for SARS-CoV-2 vaccine candidates for preclinical testing. To develop a SARS-CoV-2 vaccine, we constructed SARS-CoV-2-S1 subunit constructs and established an intracutaneous delivery platform using a novel, dissolving microneedle array (MNA) that enhances the immunogenicity of these subunit vaccines in mice, as determined by S1 specific viral titers in serum. Here, we propose to evaluate this PittCoVacc vaccine in a phase I clinical trial through a single specific aim designed to complete ongoing IND enabling studies, any additional parallel studies recommended by the FDA, and then to conduct a Phase 1 clinical trial in healthy volunteers.

Public Health Relevance

The novel coronavirus, previously dubbed 2019-nCoV, and now officially named SARS-CoV-2 which caused the corona virus disease (COVID-19) pandemic outbreak and was first detected in Wuhan, China in December 2019. Safe vaccines that rapidly induce long-lasting virus-specific immune responses are urgently needed. We have recently established that intracutaneous delivery using a novel, dissolving microneedle array the SARS-CoV-2 Spike 1 subunit vaccine (PittCoVacc) is immunogenic in a murine mouse model. Here, we propose to evaluate the PittCoVacc vaccine in an investigator-initiated phase I clinical trial. This research project will provide critically important information on the safety and immunogenicity of the PittCoVacc.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
3UM1AI106701-07S2
Application #
10147381
Study Section
Program Officer
Livnat, Daniella
Project Start
2020-07-15
Project End
2020-11-30
Budget Start
2020-07-15
Budget End
2020-11-30
Support Year
7
Fiscal Year
2020
Total Cost
Indirect Cost

  Institution

Name
University of California Los Angeles
Department
Pediatrics
Type
Schools of Medicine
DUNS #
092530369
City
Los Angeles
State
CA
Country
United States
Zip Code
90095

  Publications

Ocque, Andrew J; Hagler, Colleen E; Morse, Gene D et al. (2018) Development and validation of an LC-MS/MS assay for tenofovir and tenofovir alafenamide in human plasma and cerebrospinal fluid. J Pharm Biomed Anal 156:163-169
Chow, Felicia C; Wilson, Michael R; Wu, Kunling et al. (2018) Stroke incidence is highest in women and non-Hispanic blacks living with HIV in the AIDS Clinical Trials Group Longitudinal Linked Randomized Trials cohort. AIDS 32:1125-1135
Utay, Netanya S; Kitch, Douglas W; Yeh, Eunice et al. (2018) Telmisartan Therapy Does Not Improve Lymph Node or Adipose Tissue Fibrosis More Than Continued Antiretroviral Therapy Alone. J Infect Dis 217:1770-1781
Garcia-Prats, Anthony J; Rose, Penelope C; Draper, Heather R et al. (2018) Effect of Coadministration of Lidocaine on the Pain and Pharmacokinetics of Intramuscular Amikacin in Children With Multidrug-Resistant Tuberculosis: A Randomized Crossover Trial. Pediatr Infect Dis J 37:1199-1203
Haas, David W; Bradford, Yuki; Verma, Anurag et al. (2018) Brain neurotransmitter transporter/receptor genomics and efavirenz central nervous system adverse events. Pharmacogenet Genomics 28:179-187
Ngongondo, McNeil; Miyahara, Sachiko; Hughes, Michael D et al. (2018) Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr 78:54-61
Gianella, Sara; Marconi, Vincent C; Berzins, Baiba et al. (2018) Genital HIV-1 Shedding With Dolutegravir (DTG) Plus Lamivudine (3TC) Dual Therapy. J Acquir Immune Defic Syndr 79:e112-e114
Tam, Edward; Luetkemeyer, Anne F; Mantry, Parvez S et al. (2018) Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir-experienced, NS5A treatment-naïve patients: Findings from two randomized trials. Liver Int 38:1010-1021
El Kamari, Vanessa; Moser, Carlee; Hileman, Corrilynn O et al. (2018) Lower pretreatment gut integrity is independently associated with fat gain on antiretroviral therapy. Clin Infect Dis :
Hulgan, Todd; Ramsey, Benjamin S; Koethe, John R et al. (2018) Relationships between Adipose Mitochondrial Function, Serum Adiponectin, and Insulin Resistance in Persons with HIV after 96 weeks of Antiretroviral Therapy. J Acquir Immune Defic Syndr :

Showing the most recent 10 out of 315 publications