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INOVIO Announces Phase 2 Clinical Trial Data for the Evaluation of COVID-19 Candidate DNA Vaccines
INOVIO announces Phase 2 Trial Data of COVID-19 Candidate DNA Vaccines. On May 11th, INOVIO announced today that it has obtained safety, tolerability, and safety in the Phase 2/3 clinical trial of INO-4800, a candidate DNA vaccine for new coronavirus pneumonia in the United States.
With positive data on immunogenicity, this trial is called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy, INOVIO INO-4800 Vaccine Trial). Preliminary results show that in a larger population, INO-4800 is generally safe, tolerable and immunogenic in all age groups tested.
The results of this phase 2 clinical trial are as follows:
- The Phase 2 trial enrolled approximately 400 participants 18 years of age or older in 16 research centers in the United States.
- Participants received INO-4800 (1.0 mg or 2.0 mg dose) or placebo (randomized 3:3:1:1) within 0 to 4 weeks. Each dose of vaccine is given by intradermal injection, followed by electroporation using INOVIO’s proprietary smart device CELLECTRA®.
- Safety endpoints included local reactions at the systemic and administration site 8 weeks after the first dose (or 4 weeks after the second dose). Immunological endpoints include antigen-specific binding antibody titer, neutralization titer, and antigen-specific interferon gamma (IFN-γ) cellular immune response after two doses of vaccine.
- Vaccination is generally safe and well tolerated. The severity of most adverse events (AE) was grade 1 and 2, and the frequency of the second dose did not appear to increase. There was no difference in the number of participants in each of the most common AEs between the two dose groups.
- Compared with the 1.0 mg dose group, the geometric mean fold increase (GMFR) of the binding and neutralizing antibody levels in the 2.0 mg dose group was more statistically significant.
- Compared with the 1.0 mg dose group, the T cell immune response measured by the ELISpot (enzyme-linked immunospot) test was also higher in the 2.0 mg dose group.
- ClinicalTrials.gov identifier: NCT04642638
Phase 2 of INNOVATE aims to evaluate the safety, tolerability, and immunogenicity of INO-4800 in a three-to-one randomized grouping of two dose regimens (1.0 mg or 2.0 mg). Under this regimen, each dose Both received INO-4800 or placebo to determine the optimal dose for the two age groups (18-50 years old and 51 years old and above) for the subsequent phase 3 efficacy evaluation.
The preliminary Phase 2 results show that INO-4800 is safe, tolerable and immunogenic in all age groups tested. The experiment was coordinated and funded by the Department of Defense’s Chemical, Biological, Radiological, and Nuclear Defense Joint Program Executive Office (JPEO-CBRND), the Deputy Secretary of Defense’s Office of Health Affairs (OASD (HA)) and the National Defense Health Agency.
The results of the test can be found in the title “Safety and Immunogenicity of INO-4800 DNA Vaccine Against SARS-CoV-2: Preliminary Report on a Randomized, Blinded, Placebo-Controlled Phase 2 Clinical Trial of Adults with High Risk Viruses” (Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A Preliminary Report of a Randomized, Blinded, Placebo-controlled, Phase 2 Clinical Trial in Adults at High Risk of Viral Exposure), and before peer review Published as a preprint on MedRxiv (https://doi.org/10.1101/2021.05.07.21256652).
Dr. Laurent M. Humeau, Chief Scientific Officer of INOVIO, said: “Thank you to the volunteers who participated in the INNOVATE Phase 2 blinded trial, as well as the research partners, clinical teams and INOVIO employees who have been tirelessly working hard to advance this important work. Our Phase 2 results are here. The results of our initial phase 1 of new coronavirus pneumonia were verified in a larger population, which shows that INO-4800 is still generally safe, tolerable and immunogenic in all age groups of the study. The expanded data set has a clear dose selection , 2.0 mg can be used as the dose for the global phase 3 efficacy trial.”
INOVIO plans to submit Phase 2 preliminary results and device data to the US Food and Drug Administration (FDA). After submission and the FDA agrees to continue, the company will plan to conduct a global phase 3 clinical trial of INO-4800. The company recognizes that the global demand for new coronavirus vaccines for initial and increased doses is growing and unmet, and looks forward to supporting the launch of urgently needed additional vaccines to prevent the spread of new coronaviruses (including current and future variants) around the world.
About INO-4800 “INNOVATE” Phase 2/3 Clinical Trial
Dr. Pablo Tebas, Professor of Medicine at the University of Pennsylvania Hospital, served as the lead researcher of the INNOVATE Phase 2 team. The Phase 2 clinical trial aims to evaluate the safety, tolerability and immunogenicity of INO-4800 in two dosage regimens (1.0 mg or 2.0 mg). The trial was randomized three to one to receive INO-4800 or comfort. Drug administration to determine the more appropriate dose levels in the three age groups (18-50 years old, 51-64 years old and 65 years old and above) for the subsequent phase 3 efficacy evaluation.
The Phase 3 phase of the US INNOVATE trial is still in a partial clinical suspension until INOVIO can satisfactorily solve the remaining problems related to the CELLECTRA® 2000 device by the FDA, which will be used to deliver INO-4800 into skin cells.
The company plans to solve these remaining equipment problems before the start of Phase 2 and Phase 3 of INNOVATE. In the Phase 3 trial, INOVIO plans to recruit men and non-pregnant women 18 years of age and older to evaluate the efficacy of the recommended dose levels for each age group based on the data from the Phase 2 evaluation.
The trial will be conducted mainly on a global scale. Participants will be randomly divided into two groups to receive INO-4800 or placebo. The third phase will be case-oriented, and the final number of recruits will be determined by the incidence of new coronavirus pneumonia during the third phase. The primary endpoint of the phase 3 stage is the virological diagnosis of new coronavirus pneumonia.
INO-4800 is a candidate DNA vaccine developed by INOVIO, which can be used against the coronavirus SARS-CoV-2 that causes new coronavirus pneumonia. INOVIO has extensive experience in the study of coronaviruses and was the first company to initiate a phase 2a trial of INO-4700. INO-4700 is a candidate DNA vaccine developed against the related coronavirus that causes Middle East Respiratory Syndrome (MERS).
INO-4800 is composed of an optimized DNA plasmid, which can be directly delivered to cells in the body using a proprietary smart device to generate a strong, safe and tolerable immune response. INO-4800 can be stable for at least one year at room temperature, and stable for at least one month at 37oC.
The shelf life of INO-4800 at normal refrigeration temperature is expected to reach five years, and there is no need to freeze during transportation or storage. It is also the only nucleic acid vaccine that meets all the above requirements, and these requirements are important considerations for mass vaccination.
INOVIO announces Phase 2 Trial Data of COVID-19 Candidate DNA Vaccines
INOVIO announces Phase 2 Trial Data of COVID-19 Candidate DNA Vaccines
(source:internet, reference only)