Influenza
Conditions
Keywords
influenza, vaccine, nucleoprotein
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALOVX836 (Intramuscular)
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
BIOLOGICALPlacebo (Intramuscular)
2 consecutive administrations of placebo at Day 1 and Day 29.
BIOLOGICALOVX836 (Intranasal)
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
BIOLOGICALPlacebo (Intranasal)
2 consecutive administrations of placebo at Day 1 and Day 29.
Sponsors
Aepodia
Osivax
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
This study will be an observer-blind study with the subject-blind and the investigator-blind.
Intervention model description
Phase I, single center, randomized, observer-blind, placebo-controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Have given written informed consent approved by the relevant Ethical Committee governing the site. 2. Overtly healthy male or female subjects, as determined by medical history and medical examination. 3. Between the ages of 18 and 49 years, inclusive, on screening. 4. Between the Body Mass Index of 18 and 24 kg/m2, inclusive, on screening. 5. Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator. 6. Blood Pressure and Heart Rate within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator. 7. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Exclusion criteria
1. Previous Influenza vaccination within the 6 months before screening. 2. History of significant medical illness such as auto immune diseases, immune deficiency, uncontrolled diabetes or hypertension, heart or renal or hepatic diseases, as judged by the investigator. 3. For female subjects: pregnant or breast-feeding or of childbearing potential without appropriate contraceptive methods or with positive pregnancy test at screening. 4. Having received another vaccination within 3 months prior to screening. 5. Plan to receive other vaccine during the study period. 6. Administration of any investigational or non-registered drug or vaccine within 3 months prior to the first administration of study vaccine. 7. History of receiving blood or blood component or IgG within 3 months prior to screening. 8. Presence of acute febrile illness (temperature \> 38°C, temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Out-of-Range Safety Lab data | 28 days after last vaccine administration. | Frequency (number and percentage) of subjects with deviations from normal values of hematological and biochemical blood tests |
| Safety: Solicited local and systemic reactions | 7 days after last vaccine administration. | Frequency (number and percentage) of subjects with reported solicited local and systemic reactions |
| Safety: Unsolicited Adverse Events | 28 days after last vaccine administration. | Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE) |
| Safety: Serious Adverse Events | at end of study visit (i.e. Week 22) | Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response: frequency of subjects with NP T cell resoonse | 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). | 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. |
| Immune response: frequency of subjects with anti-NP IgG antibody titres | 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. | 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. |
| Immune response: mean NP T cell response | 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). | NP T cell response (mean ELISPOT counts) for each dose level of OVX836 administered by the intramuscular or intranasal route. |
| Immune response: anti-NP IgG antibody titres (geometric mean) | 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. | Geometric Mean in anti-NP Immunoglobulin G (IgG) (ELISA, serum) for each dose level of OVX836 administered by the intramuscular or intranasal route. |
| Immune response: frequency of subjects with anti-NP IgA antibody titres | 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. | 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. |
| Immune response: anti-NP IgA antibody titres (geometric mean) | 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. | Geometric Mean in anti-NP Immunoglobulin A (IgA) (ELISA, serum) for each dose level of OVX836 administered by the intranasal route. |
Countries
Belgium
Outcome results
None listed