Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin (NCT05581407) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin
Belgium60 participantsStarted 2022-10-03
Plain-language 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.
Who can participate
Age range18 Years – 50 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.
* 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.
Exclusion Criteria:
* 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 re…
What they're measuring
1
Safety and tolerability of a single, intramuscular injection with TETRALITE
Timeframe: 6 months
2
Safety and tolerability of a single, intramuscular injection with TETRALITE