Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin

NCT05581407 | Completed Phase 1

• 1 other identifier: 2022-500681-98-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is an obvious need for an affordable and more effective seasonal influenza vaccine. TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a licensed vaccine with the novel, potent LiteVax Adjuvant. A licensed vaccine (Cohort 1) with a normal dose \[15 ug per strain\] and no adjuvant will be compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.

Conditions

Influenza

Keywords

seasonal influenza vaccine; adjuvant

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of a single, intramuscular injection with TETRALITE

  Monitoring of systemic adverse reactions

  6 months

• Safety and tolerability of a single, intramuscular injection with TETRALITE

  Monitoring of local adverse reactions

  6 months

Secondary Outcomes (2)

• Immunogenicity of a single, intramuscular injection with TETRALITE

  9 months

• Immunogenicity of a single, intramuscular injection with TETRALITE

  9 months

Study Arms (3)

Licensed seasonal influenza vaccine

ACTIVE COMPARATOR

Biological: TETRALITE

1/5th of licensed seasonal influenza vaccine plus 1 mg LiteVax Adjuvant

EXPERIMENTAL

Biological: TETRALITE

1/5th of licensed seasonal influenza vaccine plus 4 mg LiteVax Adjuvant

EXPERIMENTAL

Biological: TETRALITE

Interventions

TETRALITE BIOLOGICAL

LiteVax Adjuvanted Seasonal Influenza Vaccine

1/5th of licensed seasonal influenza vaccine plus 1 mg LiteVax Adjuvant; 1/5th of licensed seasonal influenza vaccine plus 4 mg LiteVax Adjuvant; Licensed seasonal influenza vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination 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 (WOCBP).
• WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1.
• 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:

• History of previous laboratory confirmed influenza infection in the past 12 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 or II, with the exception of gestational diabetes) 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 indicated by investigator, e.g. hypertension.
• Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) 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.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids.
• History of hereditary angioedema (HAE), acquired angioedema (AAE) or idiopathic forms of angioedema.
• History of idiopathic urticaria within the past year.
• History of heavy smoking, 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 investigator's opinion could compromise the participant's safety and/or compliance with the protocol.
• A rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating.

Sponsors & Collaborators

• LiteVax BV: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

CEVAC, University Hospital

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 Officials

• Isabel Leroux-Roels, PhD

  CEVAC, University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Comparison of licensed influenza vaccine with study vaccines combining 1/5 of the dose of the standard vaccine added with two different doses of LiteVax Adjuvant.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 14, 2022
• Study Start: October 3, 2022
• Primary Completion: August 3, 2023
• Study Completion: October 23, 2023
• Last Updated: January 25, 2024

Record last verified: 2022-10

Locations

BE (1)