InfluenzaPhase 1NCT03594890
Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects
A Phase 1 study testing OVX836 (Intramuscular) and OVX836 (Intranasal) in people with Influenza, run by Osivax at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- OVX836 (Intramuscular) and OVX836 (Intranasal)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jun 2018to 7 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have given written informed consent approved by the relevant Ethical Committee governing the site.
- Overtly healthy male or female subjects, as determined by medical history and medical examination.
- Between the ages of 18 and 49 years, inclusive, on screening.
- Between the Body Mass Index of 18 and 24 kg/m2, inclusive, on screening.
- Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator.
- 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.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Who cannot join
- Previous Influenza vaccination within the 6 months before screening.
- 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.
- For female subjects: pregnant or breast-feeding or of childbearing potential without appropriate contraceptive methods or with positive pregnancy test at screening.
- Having received another vaccination within 3 months prior to screening.
- Plan to receive other vaccine during the study period.
- Administration of any investigational or non-registered drug or vaccine within 3 months prior to the first administration of study vaccine.
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- History of receiving blood or blood component or IgG within 3 months prior to screening.
- Presence of acute febrile illness (temperature > 38°C, temporary exclusion criteria).
- For intranasal route: common cold and rhinitis (temporary exclusion criteria).
- Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- History of alcoholism and/or drug abuse or tabagism (above 10 cigarettes a day).
- Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or chronic non-steroidal anti-inflammatory drugs (more than 4 weeks), interferon, immunomodulators, allergy shots, as judged by the Investigator.
- Positive test for HIV, HBV or HCV at screening.
- History of severe allergic reactions and/or anaphylaxis or serious adverse reactions to vaccines and antibiotics.
- Any contraindication to intranasal or intramuscular administration, as judged by the Investigator.
- Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Centre for the Evaluation of Vaccination, University of Antwerp
Antwerp, 2610
About this study
Official title: A First-in-human Phase I, Single Center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Safety and Immune Response of Increasing Doses of OVX836 Vaccine After Intramuscular (IM) or Intranasal (IN) Administrations in Healthy Subjects Aged 18-49 Years.
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- OVX836 (Intramuscular), Placebo (Intramuscular), OVX836 (Intranasal), Placebo (Intranasal)
- Keywords
- influenza, vaccine, nucleoprotein
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVX836 (Intramuscular)Biological
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
Placebo (Intramuscular)Biological
2 consecutive administrations of placebo at Day 1 and Day 29.
OVX836 (Intranasal)Biological
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
Placebo (Intranasal)Biological
2 consecutive administrations of placebo at Day 1 and Day 29.
| Study group | Role | What they receive |
|---|---|---|
| OVX836 (Intramuscular) | Experimental | OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant.
3 Dose levels tested: 30µg, 90 µg and 180 µg. Receives: Biological: OVX836 (Intramuscular) |
| Placebo (Intramuscular) | Placebo comparator | The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine. Receives: Biological: Placebo (Intramuscular) |
| OVX836 (Intranasal) | Experimental | OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant.
3 Dose levels tested: 30µg, 90 µg and 180 µg. Receives: Biological: OVX836 (Intranasal) |
| Placebo (Intranasal) | Placebo comparator | The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine. Receives: Biological: Placebo (Intranasal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Out-of-Range Safety Lab data
Frequency (number and percentage) of subjects with deviations from normal values of hematological and biochemical blood tests
Measured: 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
Measured: 7 days after last vaccine administration.
Safety: Unsolicited Adverse Events
Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE)
Measured: 28 days after last vaccine administration.
Safety: Serious Adverse Events
Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE)
Measured: at end of study visit (i.e. Week 22)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start12 Jun 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase I, single center, randomized, observer-blind, placebo-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aepodia
- Responsible party
- Sponsor
- Investigators
- Pierre Van Damme, MD, PhD, Principal investigator, Centre for the Evaluation of Vaccination, University of Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594890
- Sponsor's protocol ID
- OVX836-001
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2018
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Phase I, Single Center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Safety and Immune Response of Increasing Doses of OVX836 Vaccine After Intramuscular (IM) or Intranasal (IN) Administrations in Healthy Subjects Aged 18-49 Years.
- ClinicalTrials.gov ID
- NCT03594890
- Acronym / sponsor ID
- OVX836-001
- Conditions
- Influenza
- Keywords
- influenza, vaccine, nucleoprotein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- Aepodia
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Phase I, single center, randomized, observer-blind, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| OVX836 (Intramuscular) | Experimental | Biological: OVX836 (Intramuscular)OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant. 3 Dose levels tested: 30µg, 90 µg and 180 µg. |
| Placebo (Intramuscular) | Placebo comparator | Biological: Placebo (Intramuscular)The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine. |
| OVX836 (Intranasal) | Experimental | Biological: OVX836 (Intranasal)OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant. 3 Dose levels tested: 30µg, 90 µg and 180 µg. |
| Placebo (Intranasal) | Placebo comparator | Biological: Placebo (Intranasal)The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Have given written informed consent approved by the relevant Ethical Committee governing the site.
- Overtly healthy male or female subjects, as determined by medical history and medical examination.
- Between the ages of 18 and 49 years, inclusive, on screening.
- Between the Body Mass Index of 18 and 24 kg/m2, inclusive, on screening.
- Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator.
Key exclusion criteria (18 listed)
- Previous Influenza vaccination within the 6 months before screening.
- 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.
- For female subjects: pregnant or breast-feeding or of childbearing potential without appropriate contraceptive methods or with positive pregnancy test at screening.
- Having received another vaccination within 3 months prior to screening.
- Plan to receive other vaccine during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVX836 (Intramuscular)2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29. | Biological | OVX836 (Intramuscular) |
| Placebo (Intramuscular)2 consecutive administrations of placebo at Day 1 and Day 29. | Biological | Placebo (Intramuscular) |
| OVX836 (Intranasal)2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29. | Biological | OVX836 (Intranasal) |
| Placebo (Intranasal)2 consecutive administrations of placebo at Day 1 and Day 29. | Biological | Placebo (Intranasal) |
Primary outcome
Out-of-Range Safety Lab data
Time frame: 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
Time frame: 7 days after last vaccine administration.
Frequency (number and percentage) of subjects with reported solicited local and systemic reactions
Safety: Unsolicited Adverse Events
Time frame: 28 days after last vaccine administration.
Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE)
Safety: Serious Adverse Events
Time frame: at end of study visit (i.e. Week 22)
Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE)
6 secondary outcomes
Immune response: frequency of subjects with anti-NP IgG antibody titres
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)
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: frequency of subjects with anti-NP IgA antibody titres
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)
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
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- SponsorLink provided by the sponsor.
- Clinical UnitLink provided by the sponsor.
- Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Van Damme, MD, PhD principal investigator
Centre for the Evaluation of Vaccination, University of Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OVX836 (Intramuscular) and OVX836 (Intranasal) in people with Influenza, run by Osivax at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Out-of-Range Safety Lab data (time frame: 28 days after last vaccine administration.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.