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

Vaccination Reaction Clinical Trial

Official title: A Single-center, Observer-blind Study to Evaluate Safety, Immunogenicity, and Immunological Mechanisms of TETRALITE Influenza Vaccine With LiteVax Adjuvant, in Healthy Participants Aged 60 Years and Older and 18 to 50 Years.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The primary objective of this Phase 1b study is to evaluate the safety and tolerability of TETRALITE in participants aged 60 years and older and in participants aged 18 to 50 years. For this purpose, local and solicited Adverse Events (AEs), unsolicited AEs, and serious AEs, potential immune-mediated disease (pIMDs) and AEs of special interest (AESIs) will be assessed. For 7 days after vaccination, solicited local and systemic AEs will be recorded in a diary. Unsolicited AEs will be monitored for 28 days after vaccination. SAEs, pIMDs and AESIs will be assessed for 180 days after vaccination.

The secondary endpoints pertain to immunogenicity and include HI and MN titres. The HI antibody titers and MN antibody titers against the 4 vaccine influenza strains 7, 28 and 180 days after vaccination will be examined and compared to pre-vaccine levels. The current study aims to assess whether a dose level of 0.5 mg LVA and 1 mg LVA added to a standard dose of 15 µg of VaxigripTetra is capable of inducing a strong immune response, which could potentially translate into a higher vaccine effectiveness, especially in adults aged 60 years and older compared to adults aged 18 to 50 years. The increased susceptibility to influenza and other infectious diseases in adults aged 60 years and older is in part related to immunosenescence. Over time, the effectiveness of the immune system decreases. In general, vaccines are less immunogenic and reactogenic in the elderly compared to children or adults aged 18 to 50 years. Strategies to improve the immunogenicity in older adults include increasing the dose of antigen or adding an adjuvant.

The exploratory objectives include an evaluation of the mechanism(s) of (dose-dependent) action of LiteVax Adjuvant by using a systems vaccinology approaches including techniques to define genomic, transcriptomic, proteomic, metabolomic and lipidomic profiles and their interactions.

For this, blood samples will be collected in PAXgene tubes at Day 1 (pre-vaccination) 2 and

8. The analyses include differential gene expression and pathway analysis. The early timepoints will provide information on genes that are expressed at any given timepoint after vaccination compared to baseline. Additionally, genes that are differentially expressed in the adjuvanted vaccine group compared to the non-adjuvanted vaccine group will provide information on LiteVax Adjuvant. Finally, pathway enrichment will be performed. Given a list of differentially expressed genes, it will be determined how these genes work together, and which biological pathways are activated to induce antibody production. ;

Related Conditions & MeSH terms

• Influenza, Human
• Vaccination Reaction

• NCT number: NCT06294262
• Study type: Interventional
• Source: LiteVax BV
• Contact: Isabel Leroux-Roels, Prof. Dr.
• Phone: +32 9 332 20 68
• Email: cevac@uzgent.be
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 29, 2024
• Completion date: March 2025