Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine

NCT06294262 | Active Not Recruiting Phase 1

• 1 other identifier: 2023-508230-33-00
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics.

Conditions

Vaccination Reaction

Keywords

Vaccine adjuvant; LiteVax Adjuvant; Influenza virus vaccine; Seasonal influenza virus

Outcome Measures

Primary Outcomes (2)

• Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE

  Occurrence of solicited local and systemic AEs for 7 days, unsolicited AEs for 28 days, and SAEs, potential immune-mediated diseases (pIMDs), and adverse events of special interest (AESIs) for 180 days after vaccination. Local AEs include pain, redness, induration and swelling at the injection site. Systemic AEs include fever, headache, fatigue, myalgia, arthralgia, and malaise.

  180 days

• Characterise clinical hematology and biochemistry to TETRALITE

  Occurrence of clinically abnormal hematology and serum biochemistry laboratory values 1 day, 7 days, and 28 days after vaccination versus baseline (Day 1, pre-vaccination). Hematology parameters include platelet count, red blood cell count (corpuscular volume, corpuscular haemoglobin and % reticulocytes), white blood cell counts (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), haemoglobin and hematocrits. Biochemistry parameters include urea, creatinine, C-reactive protein, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, bilirubin, and high sensitive C-reactive protein.

  28 days

Secondary Outcomes (2)

• Characterise HI antibody response to the four vaccine strains of TETRALITE in serum

  180 days

• Characterise MN antibody response to the four vaccine strains of TETRALITE in serum

  180 days

Other Outcomes (5)

• Characterise mechanisms of action of LiteVax Adjuvant

  28 days

• Characterise T-cell responses to TETRALITE in PBMCs

  180 days

• Characterise B-cell response to TETRALITE in PBMCs

  180 days

Study Arms (6)

VaxigripTetra in healthy adults aged 18-50 years

ACTIVE COMPARATOR

A single, 0.5 mL intramuscular injection of VaxigripTetra without adjuvant in healthy adults aged 18-50 years (N = 12)

Biological: TETRALITE

VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 18-50 years

EXPERIMENTAL

A single, 0.55 mL intramuscular injection of VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 18-50 years (N = 12)

Biological: TETRALITE

VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 18-50 years

EXPERIMENTAL

A single, 0.55 mL intramuscular injection of VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 18-50 years (N = 12)

Biological: TETRALITE

VaxigripTetra in healthy adults aged 60 years or older

ACTIVE COMPARATOR

A single, 0.5 mL intramuscular injection of VaxigripTetra without adjuvant in healthy adults aged 60 years or older (N = 16)

Biological: TETRALITE

VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 60 years or older

EXPERIMENTAL

A single, 0.55 mL intramuscular injection of VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 60 years or older (N = 16)

Biological: TETRALITE

VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 60 years or older

EXPERIMENTAL

A single, 0.55 mL intramuscular injection of VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 60 years or older (N = 16)

Biological: TETRALITE

Interventions

TETRALITE BIOLOGICAL

Intramuscular injection of VaxigripTetra with or without LiteVax Adjuvant

Also known as: VaxigripTetra, LiteVax Adjuvant

VaxigripTetra in healthy adults aged 18-50 years; VaxigripTetra in healthy adults aged 60 years or older; VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 18-50 years; VaxigripTetra with 0.5 mg of LiteVax Adjuvant in healthy adults aged 60 years or older; VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 18-50 years; VaxigripTetra with 1 mg of LiteVax Adjuvant in healthy adults aged 60 years or older

Eligibility Criteria

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

You may qualify if:

• Written signed informed consent obtained before any study-related activities.
• Aged 18 to 50 years inclusive, at the time of signing the ICF in the younger age cohorts (Cohort 1, Cohort 2 and Cohort 3) and aged 60 years or older, at the time of signing the ICF in the older age cohorts (Cohort 4, Cohort 5 and Cohort 6).
• Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination (PE) 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, and one of the following conditions applies
• Women of non-childbearing potential (WONCBP) as defined in Appendix 1. or
• WOCBP and using a highly effective contraceptive method (with a failure rate of less than 1 % per year) as defined and described in Appendix 1 from at least 1 month prior to study vaccination and for 3 months post-vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to study vaccination. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit her abstinence to at least 1 month prior to study vaccination and for 3 months post-vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as contraceptive method (34).
• 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.

You may not qualify if:

• Medical Conditions
• History of previous laboratory confirmed influenza infection in the past 6 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 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).
• Current history of uncontrolled medical illness (unstable for the past 3 months) as judged by investigator, e.g. hypertension, diabetes mellitus type 2.
• Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) childhood febrile seizures, or 2) 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, except basocellular carcinoma (single lesion) that has been fully removed.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that is expected to require the use of oral or intravenous corticosteroids.
• History of hereditary angioedema, acquired angioedema or idiopathic forms of angioedema.
• History of idiopathic urticaria within the past year.
• Current or recent (\< 2 years ago) heavy smoking (\> 20 cigarettes per day). If candidate stopped smoking \> 2 years ago, the investigator will make an individual judgement based on the total packs per year and the candidate's overall health status. 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 the investigator's opinion could compromise the participant's safety and/or compliance with the protocol.

Sponsors & Collaborators

• LiteVax BV: lead
• University Hospital, Ghent: collaborator
• HarmonyCR, Melle, Belgium: collaborator

Study Sites (1)

University Hospital Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: March 5, 2024
• Study Start: January 29, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-05

Locations

BE (1)