INO-4800 / Inovio, The Wistar Institute, Advaccine Biopharma - LARVOL DELTA

Safety, Tolerability, and Immunogenicity of a DNA Vaccine (pGX9501) Against SARS-CoV-2 in Healthy Volunteers: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, and Dose-Ranging Phase I Trial. (PubMed, Vaccines (Basel)) - " The findings from this study confirm the immunogenicity and safety of the DNA vaccine pGX9501 and point to the potential role of the gut microbiota in vaccine immune responses. These insights provide practical references for the future design and development of DNA vaccines."

Clinical • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Immunogenicity and safety of a booster dose of the COVID-19 DNA vaccine in healthy adults aged 18 years and above: a single-center, randomized, observer-blind, placebo-controlled phase 2 trial. (PubMed, BMC Infect Dis) - P2 | "The booster regimen of one dose INO-4800 is safe and modestly immunogenic in individuals who previously received a two- dose regimen of INO-4800, with the 2.0 mg INO-4800 demonstrating superior immunogenicity compared to the 1.0 mg INO-4800."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease

Immunogenicity and safety of a COVID-19 DNA vaccine in healthy adults and elderly: A randomized, observer-blind, placebo-controlled phase 2 trial. (PubMed, Hum Vaccin Immunother) - P2 | "No vaccine-related serious adverse events were reported. The COVID-19 DNA vaccine INO-4800 at two doses (1.0 mg or 2.0 mg) showed an acceptable safety profile and modest immunogenicity, with the high-dose slightly more immunogenic than the low-dose.Clinical Trials Registration: www.chictr.org.cn, identifier is ChiCTR2000040146."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A head-to-head comparison of humoral and cellular immune responses of five COVID-19 vaccines in adults in China. (PubMed, Front Immunol) - "Here, SARS-CoV 2-specific immune responses to DNA vaccine (INO-4800), mRNA vaccine (BNT162b2), Adenovirus-vectored vaccine (CONVIDECIA), Protein subunit vaccine (Recombinant COVID- 19 Vaccine (Sf9 Cells)), Inactivated Vaccine (KCONVAC) were examined longitudinally in healthy adults between Jan 15, 2021 and July 5, 2021 for 6 months...BNT162b2 (mRNA vaccine) exhibits the highest antibody levels among the five vaccines evaluated, regardless of whether the target is the wild-type virus or its variants. However, its cellular immune response may be weaker compared to CONVIDECIA (adenovirus type 5 vector vaccine)."

Clinical • Head-to-Head • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Vaccination is the most effective and best way to avoid the disease of COVID-19. (PubMed, Immun Inflamm Dis) - "Among the vaccines that stimulate the host's immune system with the help of DNA are: undergoing Phase 2/3 trials including INO-4800 (International Vaccine Institute; Inovio Pharmaceuticals), Symvivo, Canada-COVID19 (AnGes, Inc.); GX-19 (Genexine, Inc.). BNT162b2 and mRNA-1273 vaccines were made by BioNTech/Pfizer/Fosun Pharma group and Moderna/NIAID group, respectively, which are considered as types of RNA vaccines...Among the inactive viral vaccines, the following can be mentioned: CoronaVac (Sinovac) WIBP vaccine (Wuhan Institute of Biological Products, Sinopharm), BBIBPCorV (Beijing Institute of Biological Products, Sinopharm), BBV152/Covaxin (Bharat Biotech, ICMR, National Institute of Virology) And among the protein-based/subunit vaccines, the following can be counted: NVX-CoV2373: (Novavax); SCB-2019 vaccine (Clover Biopharmaceuticals AUS Pty Ltd.); Covax-19 (GeneCure Biotechnologies; Vaxine Pty Ltd.) mRNA vaccines, viral vector vaccines, and protein..."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nucleic acid-based vaccine platforms against the coronavirus disease 19 (COVID-19). (PubMed, Arch Microbiol) - "Several DNA-based (ZyCoV-D, INO-4800, AG0302-COVID19, and GX-19N) and mRNA-based (BNT162b2, mRNA-1273, and ARCoV) approved vaccine platforms have been utilized for the COVID-19 prevention. Intracellular delivery of nucleic acid-based vaccines and their adverse events needs further research. Considering re-emergence of the COVID-19 variants of concern, vaccine reassessment and the development of polyvalent vaccines, or pan-coronavirus strategies, is essential for effective infection prevention."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Inovio Pharmaceuticals | N=160 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

INNOVATE: Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure (clinicaltrials.gov) - P2/3 | N=1308 | Terminated | Sponsor: Inovio Pharmaceuticals | N=7517 ➔ 1308 | Trial completion date: Feb 2023 ➔ Sep 2022 | Active, not recruiting ➔ Terminated | Trial primary completion date: Feb 2023 ➔ Sep 2022; The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

"Why hasn't The World health Organization Released the Data for INO-4800?" (@Micheal_2017)

INO-4800, a DNA Plasmid Vaccine Encoding the Ancestral SARS-CoV-2 Spike Protein, Is Stable Over a Range of Temperatures Not Requiring Ultra-Cold Chain Storage (IDWeek 2022) - No abstract available

Infectious Disease • Novel Coronavirus Disease

Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Inovio Pharmaceuticals | Trial completion date: Aug 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Combination therapy • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

"INO-4800 ?" (@jerrycliff)

Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19 (clinicaltrials.gov) - P1/2 | N=79 | Completed | Sponsor: International Vaccine Institute | Recruiting ➔ Completed | N=160 ➔ 79 | Trial completion date: Feb 2022 ➔ May 2022

Enrollment change • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Inovio Pharmaceuticals

Combination therapy • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

INNOVATE: Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure (clinicaltrials.gov) - P2/3 | N=7517 | Active, not recruiting | Sponsor: Inovio Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

Prime-boost vaccination regimens with INO-4800 and INO-4802 augment and broaden immune responses against SARS-CoV-2 in nonhuman primates. (PubMed, Vaccine) - "Both boosting schedules led to an expansion of T cells and antibody responses which were characterized by improved neutralizing and ACE2 blocking activity across wild-type SARS-CoV-2 as well as multiple variants of concern. These data illustrate the durability of immunity following vaccination with INO-4800 and additionally support the use of either INO-4800 or INO-4802 in prime-boost regimens."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"Ino-4800!" (@Allena33126267)

"So,so,so, Ino-4800 should be chosen from very first beginning?!!?" (@lily04022018)

Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Inovio Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Classical and Next-Generation Vaccine Platforms to SARS-CoV-2: Biotechnological Strategies and Genomic Variants. (PubMed, Int J Environ Res Public Health) - "COVID-19 vaccines obtained from classical and next-generation vaccine production platforms have entered clinicals trials. Biotechnology strategies of the first generation (attenuated and inactivated virus-CoronaVac, CoVaxin; BBIBP-CorV), second generation (replicating-incompetent vector vaccines-ChAdOx-1; Ad5-nCoV; Sputnik V; JNJ-78436735 vaccine-replicating-competent vector, protein subunits, virus-like particles-NVX-CoV2373 vaccine), and third generation (nucleic-acid vaccines-INO-4800 (DNA); mRNA-1273 and BNT 162b (RNA vaccines) have been used. Additionally, dendritic cells (LV-SMENP-DC) and artificial antigen-presenting (aAPC) cells modified with lentiviral vector have also been developed to inhibit viral activity. Recombinant vaccines against COVID-19 are continuously being applied, and new clinical trials have been tested by interchangeability studies of viral vaccines developed by classical and next-generation platforms."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial. (PubMed, J Infect Dis) - "INO-4800 was well tolerated in a 2-dose primary series and as a homologous booster in all adults, including the elderly. These results support further development of INO-4800 for use as a primary vaccine and as a booster."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8

"Really curious to see how @InovioPharma INO-4800 compares in their heterologous prime-boosting clinical trial. @WHO @CEPIvaccines @gavi @DrRHatchett @DrTedros @mvankerkhove" (@Andrew78471271)

Clinical

"@InovioPharma Ino-4800" (@NMMcCarthy)

"I haven't heard of INO-4800. That was developed by the military?" (@WarrenPlatts)

"#DNA #INOVIO #INO-4800 #INO-4802 "DNA vaccines are safe, easy, affordable to produce, and, unlike RNA vaccines, are stable at room temperature." D. Shulka, 2021" (@IncluPLAN)

Clinical