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Trial of an Inactivated Yellow Fever Virus Vaccine

NCT05172544 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-09-18

Study results available
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Summary

This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 1 mcg and 5 mcg of HydroVax-002 YFV vaccine given intramuscularly on Day 1 and Day 29 in up to 25 healthy adults healthy adults ≥ 18 and \< 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-002 YFV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 5 mcg.

Conditions

  • Yellow Fever

Interventions

BIOLOGICAL

HydroVax-002 YFV

Inactivated YFV vaccine

OTHER

Placebo

NaCl 0.9%, Normal Saline

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Najit Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher W Woods, MD, MPH · Duke Health

  • Emmanuel B Walter, MD, MPH · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2023-04-24
Completion
2023-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172544 on ClinicalTrials.gov