InfluenzaPhase 1TETRALITE-INCT05581407
Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin
A Phase 1 study testing TETRALITE in people with Influenza, run by LiteVax BV at 1 site in Belgium.
Trial summary
There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- TETRALITE
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Oct 2022to 23 Oct 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written signed informed consent obtained before any study-related activities.
- Aged 18 to 50 years inclusive, at the time of signing the ICF.
- Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination and laboratory tests within 21 days prior to enrollment.
- Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
- Women who are not pregnant or breastfeeding (WOCBP).
- WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1.
- Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study.
Who cannot join
- History of previous laboratory confirmed influenza infection in the past 12 months, excluding laboratory confirmed COVID-19 infections, prior to the day of study vaccination.
- Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
- Past or current history of immune mediated and/or autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus (type I or II, with the exception of gestational diabetes) and thyroid disease.
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
- Clinical conditions representing a contraindication for IM administration, as judged by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM administration or blood draws.
- History of confirmed hypersensitivity, allergy and/or anaphylaxis to eggs (ovalbumin or chicken proteins), squalene-based adjuvants, or other components of the study vaccine (neomycin, formaldehyde or octoxinol-9).
Show all 26Show fewer
- Current history of uncontrolled medical illness (unstable for the past 3 months) as indicated by investigator, e.g. hypertension.
- Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
- History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- Active malignancy or malignancy within the past 5 years.
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids.
- History of hereditary angioedema (HAE), acquired angioedema (AAE) or idiopathic forms of angioedema.
- History of idiopathic urticaria within the past year.
- History of heavy smoking, drug - or alcohol abuse/addiction (including alcohol dependence), or psychiatric condition (e.g. past or present psychoses; disorder requiring lithium; or within 5 years prior to administration of study vaccine, a history of suicide plan or attempt), which in investigator's opinion could compromise the participant's safety and/or compliance with the protocol.
- A rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating.
- Prior seasonal or pandemic influenza vaccination in the 6 months before administration of study vaccine or planning to receive the influenza vaccination during the study period.
- Prior receipt of investigational pandemic influenza vaccine in the 3 months before administration of study vaccine or planning to receive such product during the study period.
- Prior receipt of a live attenuated vaccine in the 28 days prior to administration of study vaccine, or within 14 days for subunit or inactivated vaccines other than seasonal or pandemic influenza vaccination, excluding COVID-19 vaccine.
- Prior receipt of COVID-19 vaccine in the 7 days before administration of study vaccine, or planning to receive a COVID-19 vaccine during the first 14 days following study vaccination.
- Planning to receive a vaccine during the first 28 days following the administration of study vaccine, other than COVID-19 vaccine.
- Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug or medical device in the 4 weeks prior to study vaccination.
- Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of study vaccine, or planning to receipt such product during the study period.
- Use of drugs that can affect immune response such as systemic corticosteroids (excluding topical preparations and inhaled preparations) or immunosuppressive drugs in the 30 days before study vaccination and/or in the first 28 days following study vaccination, with the exceptions that a short course of corticosteroids ≤10 days duration, or a single injection for a self-limited condition at least 2 weeks prior to enrolment will not exclude study participation.
- Current intake of drugs that increase bleeding risk, e.g. anticoagulant medication (coumarin derivatives, low molecular weight heparin, DOAC).
- Current anti-tuberculosis prophylaxis or therapy.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) and/or planning a medical procedure under full anesthesia on the day of study vaccination and/or in the first 14 days following study vaccination with the exception of a medical indication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized First-in-human, Observer-blind, 3-arm Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single Administration of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccine
There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant.
A licensed vaccine (Cohort 1) with a normal dose [15 ug per strain] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.
- Conditions
- Influenza
- Being tested
- TETRALITE
- Keywords
- seasonal influenza vaccine, adjuvant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TETRALITEBiological
LiteVax Adjuvanted Seasonal Influenza Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Licensed seasonal influenza vaccine | Active comparator | Not described Receives: Biological: TETRALITE |
| 1/5th of licensed seasonal influenza vaccine plus 1 mg LiteVax Adjuvant | Experimental | Not described Receives: Biological: TETRALITE |
| 1/5th of licensed seasonal influenza vaccine plus 4 mg LiteVax Adjuvant | Experimental | Not described Receives: Biological: TETRALITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single, intramuscular injection with TETRALITE
Monitoring of systemic adverse reactions
Measured: 6 months
Safety and tolerability of a single, intramuscular injection with TETRALITE
Monitoring of local adverse reactions
Measured: 6 months
Secondary outcomes (2)
Immunogenicity of a single, intramuscular injection with TETRALITE
Monitoring haemagglutination inhibition (HI) antibody titres against the 4 influenza strains
Measured: 9 months
Immunogenicity of a single, intramuscular injection with TETRALITE
Monitoring virus neutralisation (VN) antibody titres against the 4 influenza strains
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start3 Oct 2022
- Primary completion3 Aug 2023
- Study completion23 Oct 2023
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
- Parallel groups
- Model description
- Comparison of licensed influenza vaccine with study vaccines combining 1/5 of the dose of the standard vaccine added with two different doses of LiteVax Adjuvant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LiteVax BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Isabel Leroux-Roels, PhD, Principal investigator, CEVAC, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581407
- Sponsor's protocol ID
- 2022-500681-98-00
- Acronym
- TETRALITE-I
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized First-in-human, Observer-blind, 3-arm Study to Evaluate Safety, Tolerability, and Immunogenicity of a Single Administration of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccine
- ClinicalTrials.gov ID
- NCT05581407
- Acronym / sponsor ID
- TETRALITE-I / 2022-500681-98-00
- Conditions
- Influenza
- Keywords
- seasonal influenza vaccine, adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LiteVax BVIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Ghent
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 14 Oct 2022 (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.
There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant.
A licensed vaccine (Cohort 1) with a normal dose [15 ug per strain] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison of licensed influenza vaccine with study vaccines combining 1/5 of the dose of the standard vaccine added with two different doses of LiteVax Adjuvant.
| Arm | Type | Receives |
|---|---|---|
| Licensed seasonal influenza vaccine | Active comparator | Biological: TETRALITE |
| 1/5th of licensed seasonal influenza vaccine plus 1 mg LiteVax Adjuvant | Experimental | Biological: TETRALITE |
| 1/5th of licensed seasonal influenza vaccine plus 4 mg LiteVax Adjuvant | Experimental | Biological: TETRALITE |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written signed informed consent obtained before any study-related activities.
- Aged 18 to 50 years inclusive, at the time of signing the ICF.
- Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination and laboratory tests within 21 days prior to enrollment.
- Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
- Women who are not pregnant or breastfeeding (WOCBP).
Key exclusion criteria (26 listed)
- History of previous laboratory confirmed influenza infection in the past 12 months, excluding laboratory confirmed COVID-19 infections, prior to the day of study vaccination.
- Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
- Past or current history of immune mediated and/or autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus (type I or II, with the exception of gestational diabetes) and thyroid disease.
- Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator.
- Clinical conditions representing a contraindication for IM administration, as judged by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM administration or blood draws.
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 |
|---|---|---|
| TETRALITELiteVax Adjuvanted Seasonal Influenza Vaccine | Biological | 1/5th of licensed seasonal influenza vaccine plus 1 mg LiteVax Adjuvant, 1/5th of licensed seasonal influenza vaccine plus 4 mg LiteVax Adjuvant, Licensed seasonal influenza vaccine |
Primary outcome
Safety and tolerability of a single, intramuscular injection with TETRALITE
Time frame: 6 months
Monitoring of systemic adverse reactions
Safety and tolerability of a single, intramuscular injection with TETRALITE
Time frame: 6 months
Monitoring of local adverse reactions
2 secondary outcomes
Immunogenicity of a single, intramuscular injection with TETRALITE
Time frame: 9 months
Immunogenicity of a single, intramuscular injection with TETRALITE
Time frame: 9 months
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 25 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Isabel Leroux-Roels, PhD principal investigator
CEVAC, University Hospital Ghent, Belgium
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 TETRALITE in people with Influenza, run by LiteVax BV 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 26 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 25 Jan 2024. 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. 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?
Safety and tolerability of a single, intramuscular injection with TETRALITE (time frame: 6 months). The study lists 2 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 25 Jan 2024.