Trial of an Inactivated Yellow Fever Virus Vaccine

NCT05172544 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 20-0014U44AI145791-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HydroVax; Yellow Fever virus; dose-ranging; double blind; Placebo-Controlled; Vaccine

Outcome Measures

Primary Outcomes (6)

• Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study

  Day 1 post first vaccination to Day 180 post second vaccination

• Occurrence of All Grade 3 Unsolicited Adverse Events (AEs) From First Vaccination Through Day 29 After the Second Vaccination

  Through day 29 after the second vaccination

• Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination

  Through day 15 after the second vaccination

• Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination

  Through 7 days after each vaccination

• Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination

  Through 7 days after each vaccination

• Occurrence of Any AE Through Day 29 After the Second Vaccination

  Through day 29 after the second vaccination

Secondary Outcomes (2)

• 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

  At day 29 after first vaccination and at day 29 after second vaccination

• Geometric Mean Neutralizing Titers at Days 15 and 29 After First Vaccination and at Days 15, 29, 57, and 180 Following Second Vaccination

  At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination

Study Arms (4)

Low Dose Sentinel

EXPERIMENTAL

3 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.

Biological: HydroVax-002 YFV; Other: Placebo

Low Dose Expanded

EXPERIMENTAL

7 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 2 subject will receive placebo IM on Days 1 and 29.

Biological: HydroVax-002 YFV; Other: Placebo

High Dose Sentinel

EXPERIMENTAL

3 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.

Biological: HydroVax-002 YFV; Other: Placebo

High Dose Expanded

EXPERIMENTAL

7 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29.

Biological: HydroVax-002 YFV; Other: Placebo

Interventions

HydroVax-002 YFV BIOLOGICAL

Inactivated YFV vaccine

High Dose Expanded; High Dose Sentinel; Low Dose Expanded; Low Dose Sentinel

Placebo OTHER

NaCl 0.9%, Normal Saline

High Dose Expanded; High Dose Sentinel; Low Dose Expanded; Low Dose Sentinel

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent prior to initiation of any study procedures.
• Are able to understand and comply with planned study procedures and be available for all study visits.
• Must agree to the collection of venous blood per protocol.
• Are males or non-pregnant females, ≥18 and \<50 years of age, inclusive at time of enrollment.

You may not qualify if:

• Oral temperature is less than 100.0°F.
• Pulse is 47 to 100 beats per minute, inclusive.
• Systolic blood pressure is 85 to 140 mmHg, inclusive.
• Diastolic blood pressure is 55 to 90 mmHg, inclusive.
• Screening laboratories (WBC, Hgb, PLTs, Sodium, Potassium, Bicarbonate, Calcium, Cr, non-fasting glucose, ALT, AST, TBIL and urine protein and glucose) are within acceptable parameters\*. \*Hematology, blood chemistry and liver enzymes must be Grade 1 or less at screening; urine glucose and protein negative at screening for subjects to qualify for randomization and vaccination.
• Negative test for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw.
• Women of childbearing potential\* must use an acceptable contraception method† from at least 30 days before the first study vaccination until 30 days after the second study vaccination. \*Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year has passed since the last menses if menopausal. †Includes non-male sexual relationships, full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more and shown to be azoospermic prior to the subject receiving the study vaccination, effective intrauterine devices, NuvaRing®, tubal ligation, and licensed hormonal methods such as implants, injectables or oral contraceptives (i.e. "the pill").
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
• Sexually active males must agree to use a medically acceptable form of contraception\* in order to be in this study and must agree to continue such use until day 30 after the last vaccination. \*Medically acceptable contraceptives include: (1) surgical sterilization (such as a vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
• Have an acute illness\* or acute febrile illness (oral temperature ≥ 38C \[100.4F\]), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination. \*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation\*. \*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
• Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
• Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
• Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
• Known allergy to components of the study product\*. \*Including the following: aluminum hydroxide, sorbitol, potassium chloride, sodium chloride and polysorbate80 (Tween80)

Sponsors & Collaborators

• Najit Technologies, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Results Point of Contact

• Title: Dr. Ian Amanna
• Organization: Najít Technologies, Inc.

iamanna@najittech.com

9717273569

Study Officials

• Christopher W Woods, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

• Emmanuel B Walter, MD, MPH

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 29, 2021
• Study Start: January 13, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: September 18, 2025
• Results First Posted: May 16, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)