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UFluA 20 µg each antigen/dose

Phase 1

Human Influenza | Monoclonal antibody | Infectious Disease |Emergent BioSolutions Inc.|Last Updated: Jan 20, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

UFluA 20 µg each antigen/dose · 1 trial · 1 indication

Phase 1 1
NCT05155319Universal Influenza A Vaccine in Healthy AdultsHuman Influenza
COMPLETED27 Analytics
PHASE1COMPLETED
Universal Influenza A Vaccine in Healthy Adults
Human Influenza
NCT0515531927
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Study Endpoints

Primary Endpoints

Safety of the UFluA vaccine following one of four dose schedules as evaluated through adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs).
48 weeks

Incidence of AEs up to 4 weeks after last dose. Incidence of SAEs up to 48 weeks of study follow-up. Incidence of AESIs up to 48 weeks of study follow-up. Incidence of MAAEs up to 48 weeks of study follow-up.

Local and systemic reactogenicity of UFluA vaccination following one of four dose schedules.
seven days after each vaccination

Incidences of local reactogenicity events up to 7 days after each vaccination. Incidences of systemic reactogenicity events up to 7 days after each vaccination.

Secondary Endpoints

Anti-H. pylori ferritin immune response to UFluA vaccination.
up to 4 weeks after the last vaccination.
Anti-human ferritin immune response to UFluA vaccination.
up to 4 weeks after the last vaccination.
Humoral immune response to A1 influenza antigen following UFluA vaccination.
up to 4 weeks after the last vaccination.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Cohort 1, 1AACTIVE_COMPARATORLow dose (Day 1) plus placebo (Day 22)
Cohort 1, 1BACTIVE_COMPARATORLow dose (Day 1) plus low dose (Day 22)
Cohort 1, 1CPLACEBO_COMPARATORPlacebo (Day 1) plus Placebo (Day 22)
Cohort 2, 2AACTIVE_COMPARATORHigh dose (Day 1) plus placebo (Day 22)
Cohort 2, 2BACTIVE_COMPARATORHigh dose (Day 1) plus high dose (Day 22)
Cohort 2, 2CPLACEBO_COMPARATORPlacebo (Day 1) plus Placebo (Day 22)

Interventions

NameTypeDescription
UFluA 20 µg each antigen/doseBIOLOGICALLow dose
UFluA 60 µg each antigen/doseBIOLOGICALHigh Dose
PlaceboBIOLOGICALPlacebo
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male and female adults (18-45 years of age, inclusive) at the Screening visit. * Body mass index of 18.5-32.0 kg/m\^2 (inclusive) at the Screening visit. * Healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks p...

Countries:Australia
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Frequently asked questions about UFluA 20 µg each antigen/dose

What is UFluA 20 µg each antigen/dose used for?

UFluA 20 µg each antigen/dose is an investigational monoclonal antibody being developed for the prevention of Human Influenza. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The product is being studied in healthy adults to assess its safety and immunogenicity.

What does UFluA 20 µg each antigen/dose target?

UFluA 20 µg each antigen/dose is a monoclonal antibody designed to target influenza A viruses. As a monoclonal antibody, it is intended to bind to specific viral components to neutralize the virus. The exact molecular target has not been disclosed in available information.

Who makes UFluA 20 µg each antigen/dose?

UFluA 20 µg each antigen/dose is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the product's safety and efficacy in preventing Human Influenza.

What phase is UFluA 20 µg each antigen/dose in?

UFluA 20 µg each antigen/dose is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the product remains in early-stage clinical evaluation.

What clinical trials is UFluA 20 µg each antigen/dose in?

UFluA 20 µg each antigen/dose has been studied in one completed Phase 1 clinical trial, identified as NCT05155319, titled "Universal Influenza A Vaccine in Healthy Adults." This randomized, double-blind, placebo-controlled trial enrolled 27 healthy adult participants in Australia and evaluated the product's safety and immunogenicity.

Is UFluA 20 µg each antigen/dose the same as a universal influenza vaccine?

UFluA 20 µg each antigen/dose is being studied as a universal influenza A vaccine candidate. The Phase 1 trial NCT05155319 is titled "Universal Influenza A Vaccine in Healthy Adults," indicating its intended use as a broadly protective vaccine against influenza A strains. However, it remains investigational and is not yet approved.