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| Name | Class |
|---|---|
| University Ghent | OTHER |
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This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.
This is a Phase 2a, randomised, double-blind study in 300 adults to compare the safety and immunogenicity of OVX836 to QIV (Influvac TetraTM). One dose of OVX836 at two dose levels will be administered intramuscularly, in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine in healthy subjects aged 18-65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OVX836 - 90µg dose | Experimental | Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 90µg dose on Day 1. |
|
| OVX836 - 180µg dose | Experimental | Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 180µg dose on Day 1. |
|
| Quadrivalent seasonal influenza vaccine (Influvac TetraTM) | Active Comparator | Licensed quadrivalent seasonal influenza subunit vaccine for season 2019-2020. One full dose to be administered at Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVX836 | Biological | One single administration intramuscularly at Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata | at Day 8 versus pre-injection baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) using an electronic Diary | during 7 days after vaccine administration | |
| Proportion of subjects reporting unsolicited Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Leroux-Roels, MD, PhD | Centre for Vaccinology (CEVAC), Ghent University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Vaccinology (CEVAC) | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35464450 | Derived | Leroux-Roels I, Waerlop G, Tourneur J, De Boever F, Maes C, Bruhwyler J, Guyon-Gellin D, Moris P, Del Campo J, Willems P, Leroux-Roels G, Le Vert A, Nicolas F. Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine. Front Immunol. 2022 Apr 7;13:852904. doi: 10.3389/fimmu.2022.852904. eCollection 2022. |
| Label | URL |
|---|---|
| Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine | View source |
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Randomized assignment to experimental vaccine (2 dosage levels or active control (commercial influenza vaccine) in a 1:1:1 ratio.
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| Quadrivalent seasonal influenza vaccine (Influvac TetraTM) | Biological | One single administration intramuscularly at Day 1. |
|
| during 28 days after vaccine administration |
| Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza | 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 |
| NP-specific IFNγ T-cell activity measured by ELISPOT in the pooled age strata and by age stratum (18-49 years; 50-65 years) | at Day 8, Day 29 and Day 180 versus pre-injection baseline (Day 1) |
| NP T-cell phenotype and functionality by flow cytometry in the pooled age strata and by age stratum (18-49 years; 50-65 years) | at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180 |
| Anti-NP Immunoglobulin G (IgG) titers by ELISA at each time point in the pooled age strata and by age stratum (18-49 years; 50-65 years) | at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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