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

NCT ID: NCT05035680

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2023-11-25

Brief 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm i - Seasonal influenza vaccine

Single 0.5 mL intramuscular (IM) injection of an unadjuvanted seasonal influenza vaccine

Group Type: ACTIVE_COMPARATOR

Unadjuvanted seasonal influenza vaccine

Intervention Type: BIOLOGICAL

Single 0.5 mL IM injection

Arm ii - SWE and unadjuvanted seasonal influenza vaccine

Single 0.8 mL IM injection of SWE mixed with unadjuvanted seasonal influenza vaccine

Group Type: EXPERIMENTAL

SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)

Intervention Type: BIOLOGICAL

Single 0.8 mL IM injection

Arm iii - MF59 adjuvanted seasonal influenza vaccine

Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Group Type: ACTIVE_COMPARATOR

MF59 adjuvanted seasonal influenza vaccine

Intervention Type: BIOLOGICAL

Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Interventions

Unadjuvanted seasonal influenza vaccine

Single 0.5 mL IM injection

Intervention Type: BIOLOGICAL

SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)

Single 0.8 mL IM injection

Intervention Type: BIOLOGICAL

MF59 adjuvanted seasonal influenza vaccine

Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Be able to comprehend the full nature and purpose of the study, including possible risks.

3. 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.

4. 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).

5. 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).

6. Be able to co-operate with the study staff and comply with the requirements of the study.

Exclusion Criteria

1. 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.

2. Have a history of Guillain-Barre Syndrome

3. 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.

4. Have a history of primary immunodeficiency or secondary immunodeficiency including HIV and anatomical or functional asplenia.

5. 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)

6. 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.

7. 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).

8. 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.

9. Have taken immunosuppressants and oral or parenteral corticosteroids in the 6 months preceding the screening visit. Inhaled corticosteroids for asthma are allowed.

10. Have received any influenza vaccine in the current and past season, i.e. in the 8 months preceding the screening visit.

11. Have a history of drug or alcohol abuse in the 1 year preceding the screening visit.

12. 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.

13. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Gates Medical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BM Gates MRI

Role: STUDY_CHAIR

Gates Medical Research Institute

Related Links

https://www.fda.gov/media/135432/download

Fluad® Package Insert, 2021.

Other Identifiers

MRI- ADV02-101

Identifier Type: -

Identifier Source: org_study_id