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

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg (clinicaltrials.gov) - P2 | N=2850 | Active, not recruiting | Sponsor: Osivax | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Influenza • Respiratory Diseases

Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg (clinicaltrials.gov) - P2 | N=2850 | Recruiting | Sponsor: Osivax | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

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