Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal … (NCT06294262) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine
Belgium84 participantsStarted 2024-01-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1. Refer to Section 8.3.5 for Pregnancy Testing. The investigator is responsible for review of medical history and menstrual history to decrease the risk for inclusion of a woman with an early undetected pregnancy.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Characterise local and systemic AEs, and SAEs, pIMDs and AESIs to TETRALITE
Timeframe: 180 days
2
Characterise clinical hematology and biochemistry to TETRALITE
✕. 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.