rRSV-G protein/CsA (BARS13) / Advaccine Biopharma - LARVOL DELTA

A Phase II Random, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of a Recombinant G Protein-Based Respiratory Syncytial Virus Vaccine in Healthy Older Adults. (PubMed, Vaccines (Basel)) - "These results support further development of BARS13 as a potential RSV vaccine candidate for the elderly. Further studies are needed to evaluate the long-term efficacy and optimal dosing schedule."

Clinical • Journal • P2 data • Fatigue • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Efficacy of BARS13 in the Elderly (clinicaltrials.gov) - P2 | N=125 | Completed | Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A First-in-Human Trial to Evaluate the Safety and Immunogenicity of a G Protein-Based Recombinant Respiratory Syncytial Virus Vaccine in Healthy Adults 18-45 Years of Age. (PubMed, Vaccines (Basel)) - "BARS13 had a generally good safety and tolerability profile, and no significant difference in terms of adverse reaction severity or frequency was observed between different dose groups. The immune response in repeat-dose recipients shows more potential in further study and has guiding significance for the dose selection of subsequent studies."

Clinical • Journal • P1 data • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Efficacy of BARS13 in the Elderly (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

RSV pre-fusion F protein enhances the G protein antibody and anti-infectious responses. (PubMed, NPJ Vaccines) - "Previously we demonstrated that an RSV vaccine, BARS13, consisting of recombinant G protein from E. coli plus cyclosporine A (CsA) as an immune-modulator, can protect animals from RSV challenge without inducing vaccine-enhanced disease (VED). A 15 amino acid sequence (FP4) within the F2 region of pre-F served as a CD4 Th epitope to facilitate the anti-G antibody response. Collectively, such a combination of the FP4 peptide with the G protein and CsA provides a novel strategy for developing a safe and maximally effective recombinant G protein-containing RSV vaccine."

Journal • Immune Modulation • Infectious Disease • Inflammation • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD4 • CX3CR1

Safety and Efficacy of BARS13 in the Elderly (clinicaltrials.gov) - P2 | N=125 | Enrolling by invitation | Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. | Recruiting ➔ Enrolling by invitation | Trial completion date: Jun 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2022 ➔ Mar 2024

Enrollment status • Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Efficacy of BARS13 in the Elderly (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A First in Human Study to Evaluate the Safety and Immune Response to a Vaccine for the Treatment of a Respiratory Virus, When Administered Into the Arm in Healthy Adult Participants (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections