NCT05172544

Trial of an Inactivated Yellow Fever Virus Vaccine

A Double Blind, Randomized, Placebo-Controlled, Phase 1 Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated Yellow Fever Virus Vaccine, HydroVax-002 YFV, in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Najit Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 (the day of first vaccination is defined as Day 1) and Day 29 in healthy adults ≥ 18 and \< 50 years of age. The study will consist of two dosing groups of HydroVax-002 YFV vaccine to be enrolled sequentially. Each dose group will consist of 10 individuals who receive HydroVax-002 YFV, as well as 5 total subjects who receive placebo. Each dose-group will include a sentinel subgroup consisting of 3 vaccine and 1 placebo recipient. In each of the two (1 mcg and 5 mcg) dose phases, enrollment is halted after the dose 1 vaccination of the sentinel subgroup. Following assessment of safety and reactogenicity data of Group 1 by the Safety Monitoring Committee (SMC), the vaccine dose will be increased to 5 mcg for Group 2.

Conditions

• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	HydroVax-002 YFV	Inactivated YFV vaccine
OTHER	Placebo	NaCl 0.9%, Normal Saline

Timeline

• Start date: 2022-01-13
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2021-12-29
• Last updated: 2025-09-18
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study