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OVX836 480µg

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Harmony Biosciences Holdings, Inc.|Last Updated: Oct 31, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

OVX836 480µg · 1 trial · 1 indication

Phase 2 1
NCT05284799Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.Influenza
COMPLETED180 Analytics
PHASE2COMPLETED
Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.
Influenza
NCT05284799180
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Study Endpoints

Primary Endpoints

Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29 versus pre-injection baseline (Day 1)

Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.

Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
During 7 days after vaccine administration
Proportion of subjects reporting unsolicited AEs
During 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases
During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
During the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
During the whole study duration, 180 days

Secondary Endpoints

Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine.
At Day 1 (pre-injection baseline) and Day 29
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
At Day 1, Day 8 and Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial doseEXPERIMENTALOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.
Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + PlaceboACTIVE_COMPARATORFluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1
OVX836 480µg + PlaceboPLACEBO_COMPARATOROVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1

Interventions

NameTypeDescription
OVX836 480µgBIOLOGICALOne single administration intramuscularly at Day 1
Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)BIOLOGICALOne single administration intramuscularly at Day 1
PlaceboBIOLOGICALOne single administration intramuscularly at Day 1
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Written informed consent. 2. Healthy male or female subjects, as determined by medical history and medical examination. 3. Between the age of 18 and 55 years, inclusive. 4. Subjects who have fully been vaccinated with licensed Severe Acute Respiratory Syndrome Coronavirus-2 (...

Countries:Australia
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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about OVX836 480µg

What is OVX836 480µg used for?

OVX836 480µg is an investigational monoclonal antibody being developed for the prevention of influenza. It is currently in Phase 2 clinical development and has been studied in a completed trial involving healthy volunteers in Australia.

Who makes OVX836 480µg?

OVX836 480µg is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY.

What phase is OVX836 480µg in?

OVX836 480µg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is OVX836 480µg in?

OVX836 480µg has been studied in one completed Phase 2 trial, NCT05284799, which evaluated the immunogenicity and safety of its concomitant administration with a quadrivalent influenza vaccine in healthy volunteers. The trial enrolled 180 participants in Australia.

Is OVX836 480µg the same as OVX836?

OVX836 480µg is a specific dose formulation of the investigational drug OVX836. The 480µg designation refers to the dose strength being studied in clinical trials for influenza prevention.