GLS-5310 / GeneOne - LARVOL DELTA

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1/2 | N=183 | Completed | Sponsor: GeneOne Life Science, Inc. | Active, not recruiting ➔ Completed

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

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1/2 | N=183 | Active, not recruiting | Sponsor: GeneOne Life Science, Inc. | Phase classification: P2a ➔ P1/2 | Trial completion date: Dec 2022 ➔ Dec 2024

Phase classification • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: GeneOne Life Science, Inc. | Trial completion date: Jun 2023 ➔ Dec 2023

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

Immune response enhancement with GLS-5310 DNA primary vaccine against SARS-CoV-2 followed by administration of an mRNA vaccine heterologous boost. (PubMed, Vaccine) - "Immune responses were enhanced such that binding antibody titers, neutralizing antibody titers, and T-cell responses increased 1,187-fold, 110-fold, and 2.9-fold, respectively. This paper is the first description of the immune responses following heterologous vaccination with a DNA primary series and mRNA boost."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Preclinical safety assessment of the suction-assisted intradermal injection of the SARS-CoV-2 DNA vaccine candidate pGO-1002 in white rabbit. (PubMed, Arch Toxicol) - "Animals vaccinated with pGO-1002, administered by intradermal injection and followed by application of suction with GeneDerm, developed humoral and cellular responses against the SARS-CoV-2 antigens consistent with prior studies in rats. Collectively, it was concluded that the pGO-1002 vaccine was safe and effective under these experimental conditions and these data supported future human study of the vaccine, now known as GLS-5310, for clinical trial use."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Ophthalmology • Respiratory Diseases

Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device. (PubMed, Int J Infect Dis) - "GLS-5310 administered with the GeneDerm suction device was well tolerated and induced high levels of binding antibodies and T-cell responses. Antibody responses were similar to other DNA vaccines, whereas T cell responses were many-fold greater than DNA and non-DNA vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2a | N=183 | Active, not recruiting | Sponsor: GeneOne Life Science, Inc. | Recruiting ➔ Active, not recruiting | N=345 ➔ 183 | Trial primary completion date: Jul 2022 ➔ Nov 2022

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

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1 | N=69 | Active, not recruiting | Sponsor: GeneOne Life Science, Inc. | Recruiting ➔ Active, not recruiting

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

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1 | N=69 | Recruiting | Sponsor: GeneOne Life Science, Inc. | Not yet recruiting ➔ Recruiting

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

GLS-5310 Vaccine in Healthy Volunteers as a Booster for SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=72; Not yet recruiting; Sponsor: GeneOne Life Science, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2a; N=345; Recruiting; Sponsor: GeneOne Life Science, Inc.; Not yet recruiting ➔ Recruiting

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

GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2a; N=345; Not yet recruiting; Sponsor: GeneOne Life Science, Inc.

Clinical • New P2a trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases