The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad spectrum vaccine for Influenza. This clinical trial will evaluate the safety and the immune response of increasing doses of OVX836 after intramuscular or intranasal administrations in healthy volunteers.
This study is a single center, randomized, sequential dose escalation, placebo-controlled, observer-blind study conducted in healthy subjects aged 18-49 years. The OVX836 recombinant vaccine is based on the well conserved nucleoprotein of the Influenza virus. Three different dose levels of OVX836 (30µg, 90µg, 180µg) will be assessed sequentially and administered either by the intramuscular route (Study Part A) or by the intranasal route (Study Part B). There will be 6 cohorts in total with one cohort testing one dose level and one route of administration. Each study cohort will be composed of 12 subjects, with 9 subjects receiving the OVX836 vaccine and 3 subjects receiving the placebo. Each subject will receive one administration of OVX836 or placebo on Day 1 and one administration on Day 29. The study duration for each subject is approximately 5 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
72
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
2 consecutive administrations of placebo at Day 1 and Day 29.
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
Centre for the Evaluation of Vaccination, University of Antwerp
Antwerp, Belgium
Out-of-Range Safety Lab data
Frequency (number and percentage) of subjects with deviations from normal values of hematological and biochemical blood tests
Time frame: 28 days after last vaccine administration.
Safety: Solicited local and systemic reactions
Frequency (number and percentage) of subjects with reported solicited local and systemic reactions
Time frame: 7 days after last vaccine administration.
Safety: Unsolicited Adverse Events
Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE)
Time frame: 28 days after last vaccine administration.
Safety: Serious Adverse Events
Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE)
Time frame: at end of study visit (i.e. Week 22)
Immune response: frequency of subjects with anti-NP IgG antibody titres
Frequency (number and percentage) of subjects with an increase of anti-NP Immunoglobulin G (IgG) (ELISA, serum) for each dose level of OVX836 administered by the intramuscular or intranasal route.
Time frame: 28 days post each vaccine administration and 5 months after the 1st vaccine administration (i.e. Day 29, Day 57, Day 150) versus Day 1 pre-dose.
Immune response: anti-NP IgG antibody titres (geometric mean)
Geometric Mean in anti-NP Immunoglobulin G (IgG) (ELISA, serum) for each dose level of OVX836 administered by the intramuscular or intranasal route.
Time frame: 28 days post each vaccine administration and 5 months after the 1st vaccine administration (i.e. Day 29, Day 57, Day 150) versus Day 1 pre-dose.
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2 consecutive administrations of placebo at Day 1 and Day 29.
Immune response: frequency of subjects with anti-NP IgA antibody titres
Frequency (number and percentage) of subjects with an increase of Anti-NP Immunoglobulin A (IgA) (ELISA, nasal swab) for each dose level of OVX836 administered by the intranasal route.
Time frame: 28 days post each vaccine administration and 5 months post 1st vaccine administration (e.g. Day 29, Day 57, Day 150) versus Day 1 pre-dose.
Immune response: anti-NP IgA antibody titres (geometric mean)
Geometric Mean in anti-NP Immunoglobulin A (IgA) (ELISA, serum) for each dose level of OVX836 administered by the intranasal route.
Time frame: 28 days post each vaccine administration and 5 months post 1st vaccine administration (e.g. Day 29, Day 57, Day 150) versus Day 1 pre-dose.
Immune response: frequency of subjects with NP T cell resoonse
Frequency (number and percentage) of subjects with NP T cell response (ELISPOT, Peripheral Blood Mononuclear Cells (PBMC)) for each dose level of OVX836 by the intramuscular or intranasal route.
Time frame: Day 1 pre-dose, 7 days and 28 days post each vaccine administration, and 5 months post 1st vaccine administration (e.g. Day 1, Day 8, Day 29, Day 36, Day 57, Day 150).
Immune response: mean NP T cell response
NP T cell response (mean ELISPOT counts) for each dose level of OVX836 administered by the intramuscular or intranasal route.
Time frame: Day 1 pre-dose, 7 days and 28 days post each vaccine administration, and 5 months post 1st vaccine administration (e.g. Day 1, Day 8, Day 29, Day 36, Day 57, Day 150).