Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294262
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-24
Brief Title:
Safety Tolerability Immunogenicity and Immunological Mechanisms of TETRALITE a Novel Seasonal Influenza Vaccine
Sponsor:
LiteVax BV
Organization:
LiteVax BV
Study Overview
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TETRALITE-Ib
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
Detailed 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 05 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 mechanisms 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
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 05 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 mechanisms 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None