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| Name | Class |
|---|---|
| Harmony Clinical Research BVBA | OTHER |
| Clinfidence | UNKNOWN |
| Inferential | INDUSTRY |
| University Hospital, Ghent |
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This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.
This is a phase 2a, single center, randomized, double-blind study designed to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels (180μg or 480μg) given intramuscularly, either as a booster or a primary vaccination in approximately 160 to 220 healthy participants (aged 20-64 years) previously administered with OVX836, Influvac Tetra® or placebo in the OVX836-002 (EudraCT number: 2019-002939-28) and OVX836-003 (EudraCT number: 2021-002535-39) studies. This includes OVX836-002 participants who had received 180μg OVX836 during the influenza season 2019-2020 and OVX836-003 participants who had received 180μg, 300μg or 480μg OVX836 before the influenza season 2021-2022. Volunteers who received either Influvac Tetra® in the OVX836-002 study or a placebo in the OVX836-003 study will serve as controls and will receive a primary single dose of OVX836 480μg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OVX836 - 180μg dose level | Experimental | 180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
|
| OVX836 - 480μg dose level | Experimental | 480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVX836 shot | Biological | One single administration intramuscularly at Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation of OVX836 (180µg and 480µg) | Description: Proportion of subjects reporting: - solicited local and systemic symptoms within 7 days after vaccine administration - unsolicited AEs within 29 days after vaccine administration - SAEs during the entire study duration - ILIs and RT-PCR confirmed influenza A or B (overall and occurring more than 14 days post-vaccination, i.e., vaccine failure), RSV and/or SARS-CoV-2. | From enrollment to the end of trial at 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cell-mediated immune response to OVX836 (180μg and 480μg) in term of NPspecific IFNγ spot forming cells frequencies in peripheral blood (ELISPOT) | at Days 1, 8 and 29 | |
| Frequencies of NP-specific CD4+ and CD8+T-cells expressing IL-2, TNFα and/or IFNγ, measured by flow cytometry, following in vitro stimulation of PBMC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Groth, MD | Osivax | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Vaccinology (CEVAC) Ghent University Hospital | Ghent | Belgium |
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| ID | Term |
|---|---|
| D000079263 | Vaccine-Preventable Diseases |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| OTHER |
| KCAS Bio | UNKNOWN |
Randomized assignement to 2 dose-level of experimental vaccine (180µg and 480µg) in a 1:1 ratio for the booster group and open label assignement to 480µg dose of the experimental vaccine for the control group.
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| at Days 1, 8 and 29 |
| Cross-reactivity of the NP influenza-specific responses by IFNγ ELISPOT against selected circulating and emerging strains of influenza | at Days 1, 8 and 29 |
| Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum) | at Days 1, 8 and 29 |
| Number and percentage of subjects with an increase (two-fold and four-fold) in anti-NP IgG (ELISA, serum) | at Days 1, 8 and 29 |
| GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum) | at Days 1, 8 and 29 |
| Anti-C4bp (C4b-binding protein) oligomerization domain IgG titers (ELISA, serum) in subjects with positive result for anti-OVX313 (anti-OVX313 titer >12.5). | at Days 1, 8 and 29 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |