- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05035680
Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion
November 15, 2022 updated by: Bill & Melinda Gates Medical Research Institute
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm i - Seasonal influenza vaccine
Single 0.5 mL intramuscular (IM) injection of an unadjuvanted seasonal influenza vaccine
|
Single 0.5 mL IM injection
|
Experimental: Arm ii - SWE and unadjuvanted seasonal influenza vaccine
Single 0.8 mL IM injection of SWE mixed with unadjuvanted seasonal influenza vaccine
|
Single 0.8 mL IM injection
|
Active Comparator: Arm iii - MF59 adjuvanted seasonal influenza vaccine
Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine
|
Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 days
|
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
|
28 days
|
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
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Time Frame: 7 days
|
Local solicited AEs from Day 1 through Day 7
|
7 days
|
Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.
Time Frame: 7 days
|
Systemic solicited AEs from Day 1 through Day 7
|
7 days
|
Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.
Time Frame: 28 Days
|
TEAEs from Day 1 through Day 28
|
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)
|
SAEs from Day 1 through Day 169 (end of study)
|
169 Days (End of Study)
|
Characterize safety laboratory values.
Time Frame: 29 Days and 169 Days (End of Study)
|
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)
|
29 Days and 169 Days (End of Study)
|
Characterize safety laboratory values.
Time Frame: 29 Days and 169 Days (End of Study)
|
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)
|
29 Days and 169 Days (End of Study)
|
Characterize safety laboratory values.
Time Frame: 29 Days and 169 Days (End of Study)
|
Serum Coagulation assessments (PT,PTT, and INR) at 29 Days and 169 Days (End of Study)
|
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
|
HI antibody titers to the homologous strains included in the vaccines on Day 29 and Day 169
|
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
|
HI antibody titers to the selected non vaccine (heterologous) strains on Day 29 and Day 169
|
Day 29 and Day 169
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: BM Gates MRI, Bill & Melinda Gates Medical Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 14, 2022
Primary Completion (Anticipated)
March 25, 2023
Study Completion (Anticipated)
November 25, 2023
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 1, 2021
First Posted (Actual)
September 5, 2021
Study Record Updates
Last Update Posted (Actual)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI- ADV02-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
NPO PetrovaxCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Acute Respiratory Infection | Influenza Type B | Flu | Influenza A H3N2 | Influenza A H1N1 | Flu, Human | Influenza EpidemicRussian Federation
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
Clinical Trials on Unadjuvanted seasonal influenza vaccine
-
National Institute of Allergy and Infectious Diseases...The Emmes Company, LLCCompleted
-
Liquidia Technologies, Inc.Children's Hospital Medical Center, Cincinnati; AccelovanceCompleted
-
Center for Disease Prevention and Control of Beijing...Completed
-
National Institute of Allergy and Infectious Diseases...The Emmes Company, LLCCompleted
-
Novartis VaccinesCompleted
-
Novartis VaccinesCompleted
-
Abramson Cancer Center at Penn MedicineRecruiting
-
Butantan InstituteCompletedRNA Virus Infections | Virus Diseases | Respiratory Tract Infections | Influenza, Human | Orthomyxoviridae Infections | Physiological Effects of Drugs | VaccinesBrazil
-
NovartisNovartis VaccinesCompletedInfluenza | Seasonal InfluenzaUnited Kingdom
-
Novartis VaccinesCompletedSeasonal Influenza, VaccineGermany