ICCOV / Immuno Cure - LARVOL DELTA

Delivery of DNA-encoded vaccines and proteins in mice using cutaneous suction-mediated transfection. (PubMed, FEBS Open Bio) - "Thus, we demonstrate that vaccinating mice with the GLS-5310 SARS-CoV-2 DNA vaccine using this method yields high levels of binding antibody and T-cell responses. Additionally, suction following injection of a novel pVAX1-based expression vector yielded systemic levels of a SEAP transgene. We conclude that suction-mediated delivery of nucleic acid-based therapies and vaccines can be a valuable tool for the study of preclinical mouse models."

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

T-Cell Epitope-Based SARS-CoV-2 DNA Vaccine Encoding an Antigen Fused with Type 1 Herpes Simplex Virus Glycoprotein D (gD). (PubMed, Viruses) - "In addition, K18-hACE2 transgenic mice showed protection against intranasal challenge with the original SARS-CoV-2 strain, with reduced clinical symptoms, less weight loss, and decreased viral burden in both lung and brain tissues. The results experimentally confirm the protective role of T cells in vaccine-induced protection against SARS-CoV-2 and open perspectives for the development of universal anti-coronavirus vaccines."

Journal • Herpes Simplex • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases • IFNG • TNFA

Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV) (clinicaltrials.gov) - P2 | N=31 | Completed | Sponsor: Immuno Cure 3 Limited | Active, not recruiting ➔ Completed

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

An open-label study on the safety and immunogenicity of a PD-1-enhanced DNA vaccine used as a T cell booster for COVID-19. (PubMed, EBioMedicine) - "Single PD-1-enhanced ICCOV booster DNA vaccination did not show major safety concerns. The ICCOV booster elicited cross-reactive T cell responses to multiple SARS-CoV-2 strains, including in the elderly. This report demonstrates the T-cell boosting immunogenicity of ICCOV in the susceptible elderly population."

Journal • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • CD4 • CD8 • PD-1

Tolerability of a piezoelectric microneedle electroporator in human subjects. (PubMed, Bioeng Transl Med) - "In prior work, we introduced ePatch: an ultra-low-cost, handheld, battery-free electroporator employing a piezoelectric pulser coupled with a microneedle electrode array that showed enhanced immunogenic responses to an intradermal SARS-CoV-2 DNA vaccine in mice...Adverse effects such as pain, tenderness, erythema and swelling at the application sites were minimal, transient, and statistically indistinguishable between the experimental and placebo ePatch application, suggesting excellent tolerability towards electroporation. In summary, ePatch has a favorable tolerability profile in humans and offers the potential for the safe use of electroporation in a variety of clinical settings, including DNA and mRNA vaccination."

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

Sparsely PEGylated poly(beta-amino ester) polyplexes enhance antigen specific T-cell response of a bivalent SARS-CoV-2 DNA vaccine. (PubMed, Biomaterials) - "Despite high gene transfection in HEK293T cells, only the fully PEGylated and mixed formulations displayed significantly higher expression of the reporter gene than the negative control in dendritic cells. Further in vivo studies with a bivalent SARS-CoV-2 pDNA vaccine revealed that only the mixed formulation led to strong antigen specific T-cell responses, however this did not translate into the presence of serum antibodies indicating the need for further studies into improving immunisation with polymer delivery systems."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV) (clinicaltrials.gov) - P2 | N=31 | Active, not recruiting | Sponsor: Immuno Cure 3 Limited | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2 | N=60 ➔ 31 | Trial completion date: Oct 2023 ➔ May 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Enrollment change • Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG

Robust immunogenicity and protection with PlaCCine: A novel DNA vaccine delivered with a functionalized polymeric delivery system (VACCINES SUMMIT 2023) - "Studies using a PlaCCine SARS-CoV-2 DNA vaccine expressing spike proteins in mice and primates demonstrated induction of spike-specific neutralizing antibody responses and CD8 and CD4 spike-specific cellular responses...As such, PlaCCine vaccines could be easily deployed and delivered to contain outbreaks such as with Lassa fever, EBOLA or Marburg. PlaCCine is an important vaccine advancement that can have a positive impact on global health."

Ebola Virus Disease • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8

Design and Immunogenicity of SARS-CoV-2 DNA Vaccine Encoding RBD-PVXCP Fusion Protein. (PubMed, Vaccines (Basel)) - "Naked DNA delivery by needle-free injection allowed us to achieve antibody titers comparable with mRNA-LNP delivery in rabbits. These data identify the RBD-PVXCP DNA vaccine platform as a promising solution for robust and effective SARS-CoV-2 protection, supporting further translational study."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV) (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: Immuno Cure 3 Limited

New P2a trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8