OVX836 / Osivax, National Institute of Allergy and Infectious Diseases - LARVOL DELTA

OVX836, a Nucleoprotein based vaccine under clinical development, offers protection against Highly Pathogenic Avian Influenza viruses (H5N1 and H7N9) in mouse and ferret models (ESWI 2025) - No abstract available

Preclinical • Infectious Disease • Influenza

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg (clinicaltrials.gov) - P2 | N=2850 | Not yet recruiting | Sponsor: Osivax | Phase classification: P2b ➔ P2 | N=1500 ➔ 2850 | Trial completion date: Jul 2024 ➔ May 2026 | Trial primary completion date: Dec 2023 ➔ May 2026

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix® Tetra, a Seasonal Hemagglutinin-Based Vaccine. (PubMed, Vaccines (Basel)) - P2 | "The humoral anti-NP IgG and NP-specific CMI responses to OVX836 were strong in the two OVX836 groups, and no major interference of IIV was observed. This study supports further clinical development of OVX836 as a combined IIV/OVX836 seasonal vaccine capable of inducing robust and complementary HAI and CMI NP-specific responses."

Clinical • Journal • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836 (clinicaltrials.gov) - P2 | N=117 | Completed | Sponsor: Osivax | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine As a Booster on Participants Previously Administered with OVX836 (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Osivax | Not yet recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Jun 2025

Enrollment closed • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers. (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Osivax | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Influenza • Respiratory Diseases

Clinical update of OVX836, a novel Universal Type A influenza vaccine candidate – Title TBC (WVCE 2024) - "Sponsored by: Osivax"

Clinical • Infectious Disease • Influenza • Respiratory Diseases

A mix of OVX836, a NP-based T-cell influenza vaccine candidate, with a commercial seasonal vaccine is immunogenic and synergistically protective in mice (ISIRV-OPTIONS XII 2024) - No abstract available

Preclinical • Infectious Disease • Influenza • Respiratory Diseases

Vert Results of a second phase 2 study evaluating the concomittant administration of OVX836 with standard flu vaccines: compelling safety and immunogenecity (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • P2 data

OVX836, A NP-BASED UNIVERSAL INFLUENZA VACCINE CANDIDATE, TRIGGERS EFFECTOR CD4+ AND CYTOTOXIC CD8+ T CELLS IN HEALTHY ADULTS (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases • CD4

OVX836, a NP-based broad-spectrum influenza vaccine candidate, is safe, immunogenic and triggers cross-reactive immune response in older adults (>65 years old) (ISIRV-OPTIONS XII 2024) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity and Safety of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836 (clinicaltrials.gov) - P2 | N=214 | Not yet recruiting | Sponsor: Osivax

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (clinicaltrials.gov) - P2 | N=478 | Completed | Sponsor: Osivax | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Clinical update of OVX836, a novel Universal Type A influenza vaccine candidate (WVCE 2023) - No abstract available

Clinical • Infectious Disease • Influenza • Respiratory Diseases

Co-Administration of OVX836, NP-Based Universal Influenza Vaccine Candidate, with Conventional HA-Based Influenza Vaccine: Results of Phase 2a Clinical Trial (ESWI 2023) - No abstract available

Clinical • P2a data • Infectious Disease • Influenza • Respiratory Diseases

Co-Administration of OVX836, NP-Based Universal Influenza Vaccine Candidate, with Conventional HA-Based Influenza Vaccine: Results of Phase 2a Clinical trial (IDWeek 2023) - No abstract available

Clinical • P2a data • Infectious Disease • Influenza

Co-Administration of OVX836, NP-based Universal Influenza Vaccine Candidate, with Conventional HA-Based Influenza Vaccine: Results of Phase 2a Clinical Trial (V-Congress 2023) - No abstract available

Clinical • P2a data • Infectious Disease • Influenza • Respiratory Diseases

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial. (PubMed, Lancet Infect Dis) - P2a | "OVX836 appears to be a safe and well tolerated candidate vaccine that elicits humoral and cellular nucleoprotein-specific immune responses (including CD8 T cells at the highest dose levels) and showed a preliminary signal of protection against influenza. Therefore, OVX836 is a promising vaccine candidate for universal influenza A prevention, that warrants further trials."

Journal • P2a data • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8 • IFNG

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (clinicaltrials.gov) - P2a | N=478 | Active, not recruiting | Sponsor: Osivax | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (clinicaltrials.gov) - P2a | N=600 | Recruiting | Sponsor: Osivax | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers. (clinicaltrials.gov) - P2a | N=239 | Completed | Sponsor: Osivax | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8 • IL2

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (clinicaltrials.gov) - P2a | N=600 | Not yet recruiting | Sponsor: Osivax

New P2a trial • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers. (clinicaltrials.gov) - P2a | N=180 | Completed | Sponsor: Osivax | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases • IFNG

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg (clinicaltrials.gov) - P2b | N=1500 | Not yet recruiting | Sponsor: Osivax

New P2b trial • Infectious Disease • Influenza • Respiratory Diseases • CD4 • CD8 • IFNG • IL2

Osivax Announces Clinical and Preclinical Vaccine Data Presentations at Upcoming Global Influenza Conferences (Businesswire) - "Osivax...today announced upcoming oral presentations at the Universal Influenza Vaccines (UIV) 2022 event held September 5-7 in Oxford...Osivax will present two posters covering additional OVX836 clinical and preclinical results at the Options XI conference. The first poster describes preclinical results demonstrating the potential for higher and broader protection against influenza by co-administering OVX836 with a conventional flu vaccine. Osivax is currently conducting a Phase 2a combination trial (OVX836-004) with OVX836 and a quadrivalent inactivated influenza vaccine (QIV) in Australia, with safety results from the trial included in this poster. The second poster will share the safety profile and signals of efficacy obtained with OVX836 in the Phase 2a Dose-Optimization Study (OVX836-003)."

P2a data • Preclinical • Infectious Disease • Influenza