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OVX033 is an investigational vaccine candidate developed by the French biotechnology company Osivax.[1] It is classified in the registry as a structurally diverse substance of vaccine origin, and it is given as a solution for injection.[1] The product records in the EU Clinical Trials Information System show that OVX033 has no marketing authorisation, meaning it is still being studied and is not yet approved as a medicine.[1] The substance is also known by the same name, OVX033, which is its registry name and the name used in the trial records.[1]
OVX033 is a nucleocapsid-based vaccine candidate. The nucleocapsid is an internal protein of coronaviruses, and targeting it is intended to produce broad-spectrum protection against SARS-CoV-2 variants, as shown in a hamster challenge model study published in 2023.[2] Unlike many COVID-19 vaccines that target the spike protein on the virus surface, OVX033 focuses on the nucleocapsid protein, which changes less between virus variants.[2] The vaccine is designed to stimulate a cell-mediated immune response, meaning it aims to activate immune cells that can recognise and respond to infected cells.[2]
OVX033 is prepared as a solution for injection and is administered by intramuscular injection, meaning it is injected into a muscle.[1] In the current trial, two administrations are given one month apart, at three dose levels: 100 µg, 250 µg and 500 µg.[1] The comparison arm receives a sodium chloride 0.9% solution for infusion as a placebo.[1]
One clinical trial of OVX033 is currently registered in the EU Clinical Trials Information System. It is a Phase 1/2a, double-blind, multicentre, randomised, controlled study that plans to enrol 240 participants aged 18 years and older.[1] The trial is currently authorised but has not yet reported results.[1]
The Phase 1 part of the trial focuses on safety and reactogenicity. It measures solicited local and systemic symptoms during the 7 days after each administration, unsolicited adverse events during 29 days after each administration, and serious adverse events, medically attended adverse events and adverse events of special interest throughout the study.[1] The Phase 2a part evaluates the cell-mediated immune response to OVX033 after the first and second administrations at the three dose levels, measured by the change in NP-specific spot-forming units per million peripheral blood mononuclear cells using an IFNγ ELISPOT test.[1] This test counts how many immune cells respond to the vaccine by producing interferon-gamma, a signalling molecule that helps coordinate the immune response.[1]
The trial includes participants aged 18 years and older. The Phase 1 part includes subjects aged 18 to 49 years, while the Phase 2a part includes subjects aged 18 years and older.[1] Participants receive two intramuscular injections one month apart, and the study compares OVX033 at three dose levels against a placebo.[1]
The published preclinical study in hamsters does not report side effects in humans, and no results from the ongoing clinical trial are yet available.[2] The clinical trial is designed to collect information on solicited local and systemic reactions, unsolicited adverse events, serious adverse events and adverse events of special interest, but these data have not yet been published.[1]
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