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XRX-001 Inactivated yellow fever vaccine

Phase 1

Yellow Fever | Monoclonal antibody | Infectious Disease |GE HealthCare Technologies Inc.|Last Updated: May 5, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

XRX-001 Inactivated yellow fever vaccine · 1 trial · 1 indication

Phase 1 1
NCT00995865Trial of Yellow Fever Inactivated VaccineYellow Fever
COMPLETED60 Analytics
PHASE1COMPLETED
Trial of Yellow Fever Inactivated Vaccine
Yellow Fever
NCT0099586560
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Study Endpoints

Primary Endpoints

The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.
Measured from 0 up to 21 Days

Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe. After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42. Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.

Secondary Endpoints

Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001
Days 21 and 42, 12 months
Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.
GMT titers measured at days 21, 31 and 42 for different dose rates.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
High doseACTIVE_COMPARATOR -
Mid DoseACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATORNaCl Injectable 0.9%

Interventions

NameTypeDescription
XRX-001 Inactivated yellow fever vaccineBIOLOGICALInactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10\^8 VE/0.5mL and Mid dose = 2.2 x 10\^7 VE/0.5mL
PlaceboBIOLOGICALNaCl Injectable 0.9%
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * All aspects of the protocol explained and written informed consent obtained from the subject; * Aged 18 to 49 years, inclusive; * In good general health, without significant medical history, physical examination findings, or abnormal laboratory results; and * Subject must be a...

Countries:United States
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Frequently asked questions about XRX-001 Inactivated yellow fever vaccine

What is XRX-001 Inactivated yellow fever vaccine used for?

XRX-001 Inactivated yellow fever vaccine is an investigational vaccine being developed for the prevention of yellow fever, a viral infectious disease. It is currently in Phase 1 clinical development and is not yet approved for use. The vaccine is designed to elicit an immune response against the yellow fever virus.

Who makes XRX-001 Inactivated yellow fever vaccine?

XRX-001 Inactivated yellow fever vaccine is being developed by GE HealthCare Technologies Inc., a company traded on the New York Stock Exchange under the ticker symbol GEHC. The vaccine is currently in Phase 1 clinical development for the prevention of yellow fever.

What phase is XRX-001 Inactivated yellow fever vaccine in?

XRX-001 Inactivated yellow fever vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is being studied for the prevention of yellow fever.

What clinical trials is XRX-001 Inactivated yellow fever vaccine in?

XRX-001 Inactivated yellow fever vaccine has one completed clinical trial, identified as NCT00995865, titled "Trial of Yellow Fever Inactivated Vaccine." This Phase 1 study enrolled 60 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.

Is XRX-001 Inactivated yellow fever vaccine the same as a live attenuated yellow fever vaccine?

XRX-001 Inactivated yellow fever vaccine is an inactivated vaccine, meaning it uses a killed or inactivated form of the virus. This differs from live attenuated vaccines, which use a weakened form of the virus. The vaccine is being studied in a Phase 1 clinical trial for the prevention of yellow fever.