Other substances

INO-4800

A COVID-19 candidate DNA vaccine.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

INO-4800 is a COVID-19 candidate vaccine being developed by Inovio Pharmaceuticals. It is a candidate plasmid DNA vaccine encoding SARS-CoV-2 Spike protein, which serves as an immunogen. CELLECTRA^® electroporation system, which generates electric field in the injection site to increase the DNA uptake and expression, is experimentally used with this vaccine (Tebas et al., 2020). Similar vaccine platformh is also used for non-COVID-19 candidates, such as Lassa, Nipah, HIV, Filovirus, HPV, Cancer indications, Zika, and Hepatitis B. Currently, this COVID-19 candidate vaccine is in two Phase I/II clinical trials (1, 2).

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
DRAFT landscape of COVID-19 candidate vaccines – 26 March 2020	in vitro			Mar/26/2020
Intradermal-delivered DNA vaccine provides anamnestic protection in a rhesus macaque SARS-CoV-2 challenge model	rhesus macaques			Jul/29/2020
Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial Spike protein DNA Non-randomized non-controlled open trial Phase I clinical trial	Healthy adults		The vaccine was well-tolerated and no serious adverse effects were noted. Two-dose regimen induced production of binding antibodies, neutralizing antibodies, and a T cell response (mainly CD8+ T cells producing IFN-γ and TNF-α) in most vaccinated healthy adults. Either humoral or cellular immune response was elicited in all vaccinated subjects. Sample size: 20 (1 mg group) + 19 (2 mg group). Dosage: Two doses of either 1 mg or 2 mg each, 4 weeks apart. Endpoints: Safety and immunogenicity.	Dec/23/2020
Immunogenicity of a DNA vaccine candidate for COVID-19 DNA Animal model In vitro	COS-7, 293T, and ACE2-293T cells (Spike antigen expression); BALB/c mice; C57BL/6 mice; Hartley guinea pigs; SARS-CoV-2 strains SARS-CoV-2/WH-09/human/2020 and SARS-CoV-2/Australia/VIC01/2020 (virus neutralization assays)	12.12	The vaccine administration induced immunogen synthesis in tested cell lines. It elicited IgG binding antibody and neutralizing antibody responses in mice and guinea pigs. The induced antibodies inhibited Spike-ACE2 binding in vitro and were present in bronchoalveolar lavage fluid of vaccinated animal models. T cell response was assayed and observed in the immunized mice.	May/20/2020

AI-suggested references

Link	Publication date
Prime-boost vaccination regimens with INO-4800 and INO-4802 augment and broaden immune responses against SARS-CoV-2 in nonhuman primates.	Sep/15/2021
SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial	Apr/17/2021
Live Virus Neutralisation of the 501Y.V1 and 501Y.V2 SARS-CoV-2 Variants following INO-4800 Vaccination of Ferrets.	Jun/25/2021
Intradermal-delivered DNA vaccine induces durable immunity mediating a reduction in viral load in a rhesus macaque SARS-CoV-2 challenge model	Sep/28/2021
A novel mouse AAV6 hACE2 transduction model of wild-type SARS-CoV-2 infection studied using synDNA immunogens.	Jun/08/2021
INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global SARS-CoV-2 variants	Oct/14/2021
One or two dose regimen of the SARS-CoV-2 synthetic DNA vaccine INO-4800 protects against respiratory tract disease burden in nonhuman primate challenge model.	Jun/23/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04447781	Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19	Recruiting	Phase 1\|Phase 2	Jul/15/2020	Feb/22/2022
Alternative id - IVI COVID19-001 Interventions - Biological: INO-4800\|Device: CELLECTRA® 2000\|Other: Saline-sodium citrate (SSC) buffer Study type - Interventional Study results - No Results Available Locations - Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of\|Seoul National University Hospital, Seoul, Korea, Republic of Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Triple (Participant, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 160 Age - 19 Years to 64 Years (Adult) Outcome measures - Primary Outcome Measures
NCT04642638	Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure	Recruiting	Phase 2\|Phase 3	Nov/30/2020	Jan/01/2023
Alternative id - COVID19-311\|INNOVATE\|WHO UTN: U1111-1266-9952 Interventions - Drug: INO-4800\|Device: CELLECTRA® 2000\|Drug: Placebo Study type - Interventional Study results - No Results Available Locations - Synexus Clinical Research US, Inc - Phoenix Southeast, Chandler, Arizona, United States\|Central Phoenix Synexus Clinical Research, Phoenix, Arizona, United States\|AMR Tempe, Tempe, Arizona, United States\|Optimal Research, LLC, San Diego, California, United States\|AMR South Florida, Coral Gables, Florida, United States\|Clinical Research Trials of Florida, Inc, Tampa, Florida, United States\|AMR Lexington, Lexington, Kentucky, United States\|Walter Reed Army Institute of Research, Silver Spring, Maryland, United States\|Ascension St. John Hospital, Detroit, Michigan, United States\|AMR Kansas City, Kansas City, Missouri, United States\|AMR, Clinical Research Consortium- Las Vegas, Las Vegas, Nevada, United States\|University of Pennsylvania, Philadelphia, Pennsylvania, United States\|Thomas Jefferson University, Philadelphia, Pennsylvania, United States\|Tekton Research, San Antonio, Texas, United States\|DM Clinical Research, Tomball, Texas, United States\|Advanced Clinical Research, West Jordan, Utah, United States\|Lobus Centro de Pesquisa Clinica LTDA, Volta Redonda, Rio De Janeiro, Brazil\|CEPES Centro de Pesquisa Multidisciplinar - Faculdade de Medicina do ABC (FMABC), Santo André, São Paulo, Brazil\|IBPCLIN - Instituto Brasil de Pesquisa Clínica AS, Rio De Janeiro, Brazil\|Centro de Investigacion Medico Asistencial S.A.S, Barranquilla, Atlántico, Colombia\|Clinica de la Costa LTDA, Barranquilla, Atlántico, Colombia\|Corazon IPS S.A.S, Barranquilla, Atlántico, Colombia\|Ips Centro Cientifico Asistencial Sas, Barranquilla, Atlántico, Colombia\|Bluecare Salud S A S Sede Centro Medico Integral Chico Medplus CRI, Bogotá, Bogotá, D. C., Colombia\|BRCR Global Mexico, Guadalajara, Jalisco, Mexico\|Unidad de Medicina Especializada SMA, San Juan del Río, Querétaro, Mexico\|SMIQ, S. de R. L. de C.V., Querétaro, Mexico\|West Visayas State University Medical Center, Iloilo City, Iloilo, Philippines\|Mary Johnston Hospital, Tondò, Manila, Philippines\|Philippine General Hospital, Ermita, Metro Manila, Philippines\|Las Pinas Doctors Hospital, Las Piñas, Metro Manila, Philippines\|Asian Hospital & Medical Center, Muntinlupa, Metro Manila, Philippines\|Lung Center of the Philippines, clinical research Facility building, Quezon City, Metro Manila, Philippines\|Riverside Medical Center Inc., Bacolod City, Negros Occidental, Philippines Study designs - Allocation: Randomized\|Intervention Model: Sequential Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Prevention Enrollment - 7517 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay\|Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay\|Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease\|Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions\|Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs)\|Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)\|Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)\|Phase 3: Percentage of Participants With Death From All Causes\|Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Non-Severe COVID-19 Disease\|Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Severe COVID-19 Disease\|Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Death From COVID-19 Disease\|Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease\|Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay\|Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
NCT04336410	Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers	Completed	Phase 1	Apr/03/2020	Feb/10/2022
Alternative id - COVID19-001 Interventions - Drug: INO-4800\|Device: CELLECTRA® 2000 Study type - Interventional Study results - No Results Available Locations - Central Kentucky Research Associates, Lexington, Kentucky, United States\|Center for Pharmaceutical Research, Kansas City, Missouri, United States\|University of Pennsylvania, Philadelphia, Pennsylvania, United States Study designs - Allocation: Non-Randomized\|Intervention Model: Sequential Assignment\|Masking: None (Open Label)\|Primary Purpose: Prevention Enrollment - 120 Age - 18 Years and older (Adult, Older Adult) Outcome measures - Percentage of Participants with Adverse Events (AEs)\|Percentage of Participants with Administration (Injection) Site Reactions\|Percentage of Participants with Adverse Events of Special Interest (AESIs)\|Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers\|Change from Baseline in Antigen-Specific Cellular Immune Response

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