INO-4700 / GeneOne, Inovio - LARVOL DELTA

Safety, tolerability, and immunogenicity of a DNA-based vaccine (INO-4700) against Middle East respiratory syndrome coronavirus: phase 2a study in healthy volunteers. (PubMed, Front Immunol) - P2 | "These results warrant further evaluation of INO-4700 as a candidate vaccine for MERS-CoV outbreak preparedness and prevention. https://clinicaltrials.gov, identifier NCT04588428."

Clinical • Journal • P2a data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of the ChAdOx1, MVA-MERS-S, and GLS-5300 DNA MERS-CoV vaccines. (PubMed, Int Immunopharmacol) - "The findings showed that high doses of current MERS-CoV vaccine candidates conferred better immunogenicity than low doses and that there were no differences in the safety of the vaccines."

Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (clinicaltrials.gov) - P2 | N=192 | Completed | Sponsor: Inovio Pharmaceuticals | Active, not recruiting ➔ Completed

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

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (clinicaltrials.gov) - P2 | N=192 | Active, not recruiting | Sponsor: Inovio Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=542 ➔ 192 | Trial completion date: Jun 2024 ➔ Nov 2022 | Trial primary completion date: Jun 2024 ➔ Nov 2022

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

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (clinicaltrials.gov) - P2; N=542; Recruiting; Sponsor: Inovio Pharmaceuticals; Trial completion date: Sep 2023 ➔ Jun 2024; Trial primary completion date: Sep 2023 ➔ Jun 2024

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (clinicaltrials.gov) - P2; N=542; Recruiting; Sponsor: Inovio Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers (clinicaltrials.gov) - P2; N=542; Not yet recruiting; Sponsor: Inovio Pharmaceuticals

Clinical • New P2 trial • Infectious Disease

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial. (PubMed, Lancet Infect Dis) - P1 | "The GLS-5300 MERS coronavirus vaccine was well tolerated with no vaccine-associated serious adverse events. Immune responses were dose-independent, detected in more than 85% of participants after two vaccinations, and durable through 1 year of follow-up. The data support further development of the GLS-5300 vaccine, including additional studies to test the efficacy of GLS-5300 in a region endemic for MERS coronavirus."

Clinical • Journal • P1 data • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers (clinicaltrials.gov) - P1/2; N=60; Completed; Sponsor: GeneOne Life Science, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Nov 2020 ➔ Apr 2020; Trial primary completion date: Sep 2020 ➔ May 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Inovio and GeneOne Life Science report positive phase 1/2a clinical data with DNA vaccine INO-4700 for MERS coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference (Inovio Press Release) - "Dr. Jerome Kim...said, 'IVI is pleased to join partners in reporting these findings as a result of our collaboration in the world's first vaccine candidate against MERS. These and subsequent clinical trials could pave the way for accelerated development of a DNA vaccine against MERS.'"

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