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Virus Therapy
Trial of an Inactivated Yellow Fever Virus Vaccine
Phase 1
Waitlist Available
Led By Christopher W Woods, MD, MPH
Research Sponsored by Najit Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial tests a new vaccine called HydroVax-002 in healthy adults aged 18 to 49 years. The vaccine is given in two doses, one at the beginning and another after about a month, to see if it is safe and how people react to it. HydroVax-002 is a follow-up to HydroVax-001, which was tested for safety and effectiveness in healthy adults.
Eligible Conditions
- Neurotropic Disease
- Yellow Fever
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 1 trial • 26 Patients • NCT0517254420%
COVID-19
10%
Abdominal pain
10%
Vessel puncture site bruise
10%
Periorbital swelling
10%
Haemorrhoids
10%
Otitis media
10%
Vulvovaginal mycotic infection
10%
Skin laceration
10%
Oropharyngeal pain
10%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose
High Dose
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Low Dose SentinelExperimental Treatment2 Interventions
3 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.
Group II: Low Dose ExpandedExperimental Treatment2 Interventions
7 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 2 subject will receive placebo IM on Days 1 and 29.
Group III: High Dose SentinelExperimental Treatment2 Interventions
3 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.
Group IV: High Dose ExpandedExperimental Treatment2 Interventions
7 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HydroVax-002 YFV
2022
Completed Phase 1
~30
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,327 Previous Clinical Trials
5,365,963 Total Patients Enrolled
Najit Technologies, Inc.Lead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Christopher W Woods, MD, MPHPrincipal InvestigatorDuke Health
Emmanuel B Walter, MD, MPHPrincipal InvestigatorDuke Health
5 Previous Clinical Trials
1,817 Total Patients Enrolled