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Virus Therapy

HydroVax-002 YFV for Yellow Fever

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
Pulse is 47 to 100 beats per minute, inclusive.
Systolic blood pressure is 85 to 140 mmHg, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 after the second vaccination
Awards & highlights

Study Summary

This trial will assess the safety of a new yellow fever vaccine given in two doses.

Eligible Conditions
  • Yellow Fever

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your heart rate should be between 47 to 100 beats per minute.
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Your blood pressure should be between 85 and 140 mmHg (the top number).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of all Grade 3 laboratory toxicities from first vaccination through day 15 after the second vaccination
Occurrence of all Grade 3 unsolicited adverse events (AEs) from first vaccination through day 29 after the second vaccination
Occurrence of all serious adverse events (SAEs) at any time during the study
+3 more
Secondary outcome measures
Geometric mean neutralizing titers at days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination
Percentage of subjects achieving seroconversion (greater than or equal to 1:10 in plaque reduction neutralizing titer [PRNT50] titer) at day 29 after first vaccination and at day 29 after second vaccination
Reverse cumulative distribution curve of neutralizing titers on Days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 after the second vaccination for each dose group and for all dose groups combined

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?

Najit Technologies, Inc.Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,482,981 Total Patients Enrolled
8 Trials studying Yellow Fever
1,100 Patients Enrolled for Yellow Fever
Christopher W Woods, MD, MPHPrincipal InvestigatorDuke Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Mar 2025