InfluenzaPhase 1NCT05035680

Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion

A Phase 1 study testing Unadjuvanted seasonal influenza vaccine, SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV) and MF59 adjuvanted seasonal influenza vaccine in people with Influenza, run by Gates Medical Research Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of the study is to characterize safety and tolerability of the squalene-based adjuvant candidate SWE and its potential to enhance the immune response to seasonal influenza vaccine antigens in healthy older adults. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Unadjuvanted seasonal influenza vaccine, SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV) and MF59 adjuvanted seasonal influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 14 Jul 2022to 25 Nov 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be willing to participate in the study, as demonstrated by signing the written informed consent form approved by the Ethics Committee/Institutional Review Board (EC/IRB) before any study procedure is performed.
Be able to comprehend the full nature and purpose of the study, including possible risks.
Be a healthy male or female without acute or chronic medical condition per the Investigator's judgement between 18 to 50 years of age (Part 1) and ≥65 years of age (Part 2) on the day of randomization, inclusive.
Have a BMI between 18.0 kg/m2 and 32.0 kg/m2. BMI values should be rounded to the nearest integer (e.g., round down 32.4 to 32.0, round up 18.6 to 19.0).
All female participants: have a negative pregnancy test or post-menopausal status. Postmenopausal status is defined as 12 months with no menses without alternative medical cause. Female participants of childbearing potential (Part 1): have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization, not breastfeeding, and willing to use highly effective methods of contraception 14 days before study drug administration through last scheduled follow up visit (End of Study). Male participants with female partners of child-bearing potential (Part 1): agree to use one of the following contraception methods from the day of randomization to the last follow-up visit of the partner: vasectomy with documentation of azoospermia, or male condom use; agree to not donate sperm prior to the last scheduled follow-up visit (End of Study).
Be able to co-operate with the study staff and comply with the requirements of the study.

Who cannot join

Have a history of intolerance, hypersensitivity, or allergy to any component of the study products and/or have a history of anaphylaxis to any drug or vaccines.
Have a history of Guillain-Barre Syndrome
Have a clinically significant history of hepatic, renal, cardiovascular, or any other disease or disorder, including psychological or psychiatric, that in the investigator's opinion may increase the risk to the participant, and/or jeopardize the participant's compliance with the study procedures.
Have a history of primary immunodeficiency or secondary immunodeficiency including HIV and anatomical or functional asplenia.
Have one or more abnormal laboratory values at the screening visit that in the opinion of the Investigator, are clinically significant, including but not limited to the following: Alanine Aminotransferase (ALT) > 2 x upper limit of normal (ULN) Serum creatinine above the ULN Bilirubin > 2 x ULN Internal Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) above the ULN Hemoglobin < 12 g/dL in men, and <11 g/dL in women Platelets below the lower limit of normal (LLN)
Have had clinical signs and symptoms consistent with Coronavirus Disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV2) infection-19 (COVID-19), i.e. fever, cough, dyspnea, sore throat, fatigue, loss of smell, loss of taste, or confirmed SARS-CoV-2 infection by appropriate laboratory test in the 1 month preceding the screening visit.

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Have had influenza-like illness (ILI) in the 3 months preceding the screening visit. ILI is defined as fever (oral temperature ≥37.8 C / ≥100 F) and cough or sore throat (CDC definition).
Have received an investigational drug or vaccine in the 3 months preceding the screening visit, including COVID-19 investigational vaccine or treatment. Note: vaccination with an approved vaccine for the prevention of COVID-19 is allowed.
Have taken immunosuppressants and oral or parenteral corticosteroids in the 6 months preceding the screening visit. Inhaled corticosteroids for asthma are allowed.
Have received any influenza vaccine in the current and past season, i.e. in the 8 months preceding the screening visit.
Have a history of drug or alcohol abuse in the 1 year preceding the screening visit.
Have a history of basal cell carcinoma or non-invasive squamous cell carcinoma of the skin in the 1 year preceding the screening visit and/or a history of any other malignancy in the 5 years preceding the screening visit.
Have any other condition or situation that in the investigator's opinion might increase the risk to the participant or jeopardize the participant's compliance with study procedures.

About this study

Conditions: Influenza
Being tested: Unadjuvanted seasonal influenza vaccine, SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV), MF59 adjuvanted seasonal influenza vaccine
Keywords: vaccine, influenza, 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.

Unadjuvanted seasonal influenza vaccineBiological
Single 0.5 mL IM injection
SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)Biological
Single 0.8 mL IM injection
MF59 adjuvanted seasonal influenza vaccineBiological
Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Study groups in NCT05035680
Study group	Role	What they receive
Arm i - Seasonal influenza vaccine	Active comparator	Single 0.5 mL intramuscular (IM) injection of an unadjuvanted seasonal influenza vaccine Receives: Biological: Unadjuvanted seasonal influenza vaccine
Arm ii - SWE and unadjuvanted seasonal influenza vaccine	Experimental	Single 0.8 mL IM injection of SWE mixed with unadjuvanted seasonal influenza vaccine Receives: Biological: SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)
Arm iii - MF59 adjuvanted seasonal influenza vaccine	Active comparator	Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine Receives: Biological: MF59 adjuvanted seasonal influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
Severe systemic solicited AEs from Day 1 through Day 7
Measured: 7 days
Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
Severe and serious unsolicited TEAEs from Day 1 through Day 28
Measured: 28 days
Characterize the adjuvant effect of SWE on the hemagglutinin inhibition (HI) antibody response to the A/H3N2 vaccine strain.
HI antibody titer to the influenza A H3N2 (A/H3N2) vaccine strain on Day 29
Measured: Day 29

Secondary outcomes (9)

Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Local solicited AEs from Day 1 through Day 7
Measured: 7 days
Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Systemic solicited AEs from Day 1 through Day 7
Measured: 7 days
Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.
TEAEs from Day 1 through Day 28
Measured: 28 Days
Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.
SAEs from Day 1 through Day 169 (end of study)
Measured: 169 Days (End of Study)
Characterize safety laboratory values.
Hematology assessments (complete blood count (red blood cells, hemoglobin, platelets and white blood cells) and differential (absolute counts) including neutrophils, lymphocytes, monocytes, eosinophils and basophils)) at 29 Days and 169 Days (End of Study)
Measured: 29 Days and 169 Days (End of Study)
Characterize safety laboratory values.
Serum Chemistry assessments (ALT, AST, ALP, total bilirubin, creatinine, BUN, CRP, sodium and potassium, and chloride) at 29 Days and 169 Days (End of Study)
Measured: 29 Days and 169 Days (End of Study)
Characterize safety laboratory values.
Serum Coagulation assessments (PT,PTT, and INR) at 29 Days and 169 Days (End of Study)
Measured: 29 Days and 169 Days (End of Study)
Characterize the adjuvant effect of SWE on HI antibody responses to homologous and heterologous influenza vaccine strains through HI antibody titer, peripheral blood mononuclear cell(PBMC), and exploratory laboratory assessments.
HI antibody titers to the homologous strains included in the vaccines on Day 29 and Day 169
Measured: Day 29 and Day 169
Characterize the adjuvant effect of SWE on HI antibody responses to homologous and heterologous influenza vaccine strains through HI antibody titer, peripheral blood mononuclear cell(PBMC), and exploratory laboratory assessments.
HI antibody titers to the selected non vaccine (heterologous) strains on Day 29 and Day 169
Measured: Day 29 and Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202225 Nov 2023

First posted5 Sep 2021
Study start14 Jul 2022 (estimated)
Primary completion25 Mar 2023 (estimated)
Study completion25 Nov 2023 (estimated)

Why it stopped: Study cancelled

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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05035680
Sponsor's protocol ID: MRI- ADV02-101
Status last verified: Nov 2022
First submitted: 31 Aug 2021
Last updated: 17 Nov 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion
ClinicalTrials.gov ID: NCT05035680
Acronym / sponsor ID: MRI- ADV02-101
Conditions: Influenza
Keywords: vaccine, influenza, adjuvant
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study cancelled
Enrolment: 0 participants (actual)
Lead sponsor: Gates Medical Research InstituteUniversity, hospital or other
Collaborators: IQVIA Pty Ltd
Study start: 14 Jul 2022 (estimated)
Primary completion: 25 Mar 2023 (estimated)
Study completion: 25 Nov 2023 (estimated)
First posted: 5 Sep 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Arm i - Seasonal influenza vaccine	Active comparator	Biological: Unadjuvanted seasonal influenza vaccineSingle 0.5 mL intramuscular (IM) injection of an unadjuvanted seasonal influenza vaccine
Arm ii - SWE and unadjuvanted seasonal influenza vaccine	Experimental	Biological: SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)Single 0.8 mL IM injection of SWE mixed with unadjuvanted seasonal influenza vaccine
Arm iii - MF59 adjuvanted seasonal influenza vaccine	Active comparator	Biological: MF59 adjuvanted seasonal influenza vaccineSingle 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Be willing to participate in the study, as demonstrated by signing the written informed consent form approved by the Ethics Committee/Institutional Review Board (EC/IRB) before any study procedure is performed.
Be able to comprehend the full nature and purpose of the study, including possible risks.
Be a healthy male or female without acute or chronic medical condition per the Investigator's judgement between 18 to 50 years of age (Part 1) and ≥65 years of age (Part 2) on the day of randomization, inclusive.
Have a BMI between 18.0 kg/m2 and 32.0 kg/m2. BMI values should be rounded to the nearest integer (e.g., round down 32.4 to 32.0, round up 18.6 to 19.0).
All female participants: have a negative pregnancy test or post-menopausal status. Postmenopausal status is defined as 12 months with no menses without alternative medical cause. Female participants of childbearing potential (Part 1): have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization, not breastfeeding, and willing to use highly effective methods of contraception 14 days before study drug administration through last scheduled follow up visit (End of Study). Male participants with female partners of child-bearing potential (Part 1): agree to use one of the following contraception methods from the day of randomization to the last follow-up visit of the partner: vasectomy with documentation of azoospermia, or male condom use; agree to not donate sperm prior to the last scheduled follow-up visit (End of Study).

Key exclusion criteria (13 listed)

Have a history of intolerance, hypersensitivity, or allergy to any component of the study products and/or have a history of anaphylaxis to any drug or vaccines.
Have a history of Guillain-Barre Syndrome
Have a clinically significant history of hepatic, renal, cardiovascular, or any other disease or disorder, including psychological or psychiatric, that in the investigator's opinion may increase the risk to the participant, and/or jeopardize the participant's compliance with the study procedures.
Have a history of primary immunodeficiency or secondary immunodeficiency including HIV and anatomical or functional asplenia.
Have one or more abnormal laboratory values at the screening visit that in the opinion of the Investigator, are clinically significant, including but not limited to the following: Alanine Aminotransferase (ALT) > 2 x upper limit of normal (ULN) Serum creatinine above the ULN Bilirubin > 2 x ULN Internal Normalized Ratio (INR), Prothrombin Time (PT), Partial Thromboplastin Time (PTT) above the ULN Hemoglobin < 12 g/dL in men, and <11 g/dL in women Platelets below the lower limit of normal (LLN)

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
Unadjuvanted seasonal influenza vaccineSingle 0.5 mL IM injection	Biological	Arm i - Seasonal influenza vaccine
SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)Single 0.8 mL IM injection	Biological	Arm ii - SWE and unadjuvanted seasonal influenza vaccine
MF59 adjuvanted seasonal influenza vaccineSingle 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine	Biological	Arm iii - MF59 adjuvanted seasonal influenza vaccine

Primary outcome

Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
Time frame: 7 days
Severe systemic solicited AEs from Day 1 through Day 7
Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days.
Time frame: 28 days
Severe and serious unsolicited TEAEs from Day 1 through Day 28
Characterize the adjuvant effect of SWE on the hemagglutinin inhibition (HI) antibody response to the A/H3N2 vaccine strain.
Time frame: Day 29
HI antibody titer to the influenza A H3N2 (A/H3N2) vaccine strain on Day 29

9 secondary outcomes

Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Time frame: 7 days
Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Time frame: 7 days
Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.
Time frame: 28 Days
Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.
Time frame: 169 Days (End of Study)
Characterize safety laboratory values.
Time frame: 29 Days and 169 Days (End of Study)
Characterize safety laboratory values.
Time frame: 29 Days and 169 Days (End of Study)
Characterize safety laboratory values.
Time frame: 29 Days and 169 Days (End of Study)
Characterize the adjuvant effect of SWE on HI antibody responses to homologous and heterologous influenza vaccine strains through HI antibody titer, peripheral blood mononuclear cell(PBMC), and exploratory laboratory assessments.
Time frame: Day 29 and Day 169
Characterize the adjuvant effect of SWE on HI antibody responses to homologous and heterologous influenza vaccine strains through HI antibody titer, peripheral blood mononuclear cell(PBMC), and exploratory laboratory assessments.
Time frame: Day 29 and Day 169

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Fluad® Package Insert, 2021.Link 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.

BM Gates MRI study chair

Gates Medical Research Institute

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Characterize the severe/serious adverse event (SAE) burden of SWE combined with a seasonal influenza vaccine over 28 days. (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05035680.

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 17 Nov 2022.