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

NCT05035680 | Withdrawn Phase 1 DMC

• 1 other identifier: MRI- ADV02-101
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

vaccine; influenza; adjuvant

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Day 29

Secondary Outcomes (9)

• Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.

  7 days

• Characterize reactogenicity of SWE and MF59 combined with a seasonal influenza vaccine.

  7 days

• Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.

  28 Days

• Characterize treatment-emergent adverse events (TEAEs) of SWE and MF59 combined with a seasonal influenza vaccine.

  169 Days (End of Study)

• Characterize safety laboratory values.

  29 Days and 169 Days (End of Study)

Study Arms (3)

Arm i - Seasonal influenza vaccine

ACTIVE COMPARATOR

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

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

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

Biological: MF59 adjuvanted seasonal influenza vaccine

Interventions

Unadjuvanted seasonal influenza vaccine BIOLOGICAL

Single 0.5 mL IM injection

Arm i - Seasonal influenza vaccine

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

Single 0.8 mL IM injection

Arm ii - SWE and unadjuvanted seasonal influenza vaccine

MF59 adjuvanted seasonal influenza vaccine BIOLOGICAL

Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Arm iii - MF59 adjuvanted seasonal influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gates Medical Research Institute: lead
• Iqvia Pty Ltd: collaborator

Related Links

• Fluad® Package Insert, 2021.

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• BM Gates MRI

  Gates Medical Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 5, 2021
• Study Start: July 14, 2022
• Primary Completion: March 25, 2023
• Study Completion: November 25, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11