Yellow FeverPhase 1NCT05172544
Trial of an Inactivated Yellow Fever Virus Vaccine
A Phase 1 study testing HydroVax-002 YFV in people with Yellow Fever, run by Najit Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- HydroVax-002 YFV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2022to 24 Apr 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria (see below) as well as herbals, vitamins and supplements are permitted.
- Oral temperature is less than 100.0°F.
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- 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.
Who cannot join
- 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)
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- Unstable seizure disorder (defined as requiring medication for seizure control or with seizure activity within the past 3 years).
- Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
- Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere* with subject compliance or safety evaluations. *As determined by the site PI or appropriate sub-investigator.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
- Have a history of asthma, other than mild, well-controlled asthma*. *Cold or exercise induced asthma controlled with inhaled medications other than inhaled corticosteroids is permissible. Participants should be excluded if they require daily bronchodilator use, or have had an asthma exacerbation requiring oral/parenteral steroid use or have used theophylline or inhaled corticosteroids in the past year.
- Have a history of diabetes mellitus.
- Have taken oral or parenteral (including intra-articular) or chronic topical corticosteroids of any dose within 30 days prior to study vaccination*. *Corticosteroid nasal sprays for allergic rhinitis are permissible. Persons using a topical corticosteroid for a limited duration for mild uncomplicated dermatitis such as poison ivy or contact dermatitis may be enrolled the day after their therapy is completed.
- Have taken high-dose inhaled corticosteroids* within 30 days prior to study vaccination. *High-dose defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
- Received or plan to receive a licensed, live vaccine within 30 days before or after each study vaccination.
- Received or plan to receive a licensed, inactivated vaccine or allergy desensitization shot within 14 days before or after each study vaccination.
- Received an experimental agent* within 30 days prior to the study vaccination or expect to receive another experimental agent† during the trial-reporting period‡. *Including vaccine, drug, biologic, device, blood product, or medication. †Other than from participation in this trial. ‡Approximately 7 months after the first study vaccination.
- Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the trial-reporting period†. *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. †Approximately 7 months after the first study vaccination.
- Female subjects who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
- Receipt of blood products or immunoglobulin within six months prior to enrollment.
- Donation of a unit of blood within 60 days prior to enrollment or intends to donate blood during the study period.
- Body mass index (BMI) ≥ 35.
- History of a visit to South America, sub-Saharan Africa or Southeast Asia lasting one month or more.
- Planned travel to areas known to be endemic with Yellow Fever virus during the study period.
- History of military service.
- History of vaccination against dengue, yellow fever, tick-borne encephalitis, or Japanese encephalitis.
- History of vaccination with other flavivirus candidate vaccines.
- Attended primary (grade) school in Austria, Germany, Japan, South Korea, India, Thailand, Nepal, Vietnam, or Taiwan (locations where the tick-borne encephalitis vaccine is given).
- History of yellow fever.
- Plan to have a major change in exercise routine or perform strenuous exercise from 72 hours before any dose of study vaccine/placebo and for 72 hours before any safety laboratories*. *Safety laboratories are obtained on Days 4 and 15 following each dose of study product.
- Contraindication to intramuscular vaccination of either upper arm (for example, due to lymphadenectomy or obscuring tattoos).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: 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
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.
Read the 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
- Being tested
- HydroVax-002 YFV, Placebo
- Keywords
- HydroVax, Yellow Fever virus, dose-ranging, double blind, Placebo-Controlled, Vaccine
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroVax-002 YFVBiological
Inactivated YFV vaccine
PlaceboOther
NaCl 0.9%, Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: HydroVax-002 YFV; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study
Measured: 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
Measured: Through day 29 after the second vaccination
Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination
Measured: Through day 15 after the second vaccination
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Measured: Through 7 days after each vaccination
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Measured: Through 7 days after each vaccination
Occurrence of Any AE Through Day 29 After the Second Vaccination
Measured: 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
Measured: 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
Measured: At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start13 Jan 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Najit Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher W Woods, MD, MPH, Principal investigator, Duke HealthEmmanuel B Walter, MD, MPH, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172544
- Sponsor's protocol ID
- 20-001
- Other IDs
- 4U44AI145791-02
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2021
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05172544
- Acronym / sponsor ID
- 20-001
- Conditions
- Yellow Fever
- Keywords
- HydroVax, Yellow Fever virus, dose-ranging, double blind, Placebo-Controlled, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Najit Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose Sentinel | Experimental | Biological: HydroVax-002 YFV, Other: Placebo3 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29. |
| Low Dose Expanded | Experimental | Biological: HydroVax-002 YFV, Other: Placebo7 subjects will receive 1 mcg intramuscularly (IM) of HydroVax-002 YFV and 2 subject will receive placebo IM on Days 1 and 29. |
| High Dose Sentinel | Experimental | Biological: HydroVax-002 YFV, Other: Placebo3 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29. |
| High Dose Expanded | Experimental | Biological: HydroVax-002 YFV, Other: Placebo7 subjects will receive 5 mcg intramuscularly (IM) of HydroVax-002 YFV and 1 subject will receive placebo IM on Days 1 and 29. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
- Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room or urgent care for condition, or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose or in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low dose topical, corticosteroids as outlined in the Subject Exclusion Criteria (see below) as well as herbals, vitamins and supplements are permitted.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroVax-002 YFVInactivated YFV vaccine | Biological | High Dose Expanded, High Dose Sentinel, Low Dose Expanded, Low Dose Sentinel |
| PlaceboNaCl 0.9%, Normal Saline | Other | High Dose Expanded, High Dose Sentinel, Low Dose Expanded, Low Dose Sentinel |
Primary outcome
Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study
Time frame: 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
Time frame: Through day 29 after the second vaccination
Occurrence of All Grade 3 Laboratory Toxicities From First Vaccination Through Day 15 After the Second Vaccination
Time frame: Through day 15 after the second vaccination
Occurrence of Solicited Local AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Time frame: Through 7 days after each vaccination
Occurrence of Solicited Systemic AE and Reactogenicity Signs and Symptoms in the 7 Days After Each Vaccination
Time frame: Through 7 days after each vaccination
Occurrence of Any AE Through Day 29 After the Second Vaccination
Time frame: Through day 29 after the second vaccination
2 secondary outcomes
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
Time frame: 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
Time frame: At days 15 and 29 after first vaccination and at days 15, 29, 57, and 180 following second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher W Woods, MD, MPH principal investigator
Duke Health
Emmanuel B Walter, MD, MPH principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HydroVax-002 YFV in people with Yellow Fever, run by Najit Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of All Serious Adverse Events (SAEs) at Any Time During the Study (time frame: Day 1 post first vaccination to Day 180 post second vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.