Yellow Fever Vaccine for Yellow Fever

Overseen By Ian J Amanna, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Najit Technologies, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Corticosteroids, others

Disqualifiers: Immunosuppression, Neoplastic disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new yellow fever vaccine, HydroVax-002 YFV, to determine its safety and tolerability in healthy adults. Participants will receive varying doses of the vaccine or a placebo, with the goal of monitoring side effects and the body's response. As an early-phase trial, the focus is on safety rather than effectiveness. Generally healthy individuals aged 18 to 49 who have not been vaccinated against yellow fever or related viruses may qualify for this study. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify that you must stop taking your current medications. However, any changes in chronic prescription medication should not have occurred in the 60 days prior to enrollment, unless they are due to a change of healthcare provider or insurance, and are within the same class of medication. You can continue taking chronic or as-needed medications if they pose no additional risk to your safety or the study's assessments, as determined by the study investigator.

Is there any evidence suggesting that the HydroVax-002 YFV vaccine is likely to be safe for humans?

Research shows that the HydroVax-002 YFV vaccine is undergoing tests to determine its safety and tolerability. Similar vaccines have occasionally caused serious side effects, though these are rare. For instance, live yellow fever vaccines can lead to serious issues in 47 out of a million people. HydroVax-002 is in the early testing stages, so researchers are still carefully assessing its safety. However, reaching this stage indicates it is considered safe enough for human testing. This trial will help determine how well people can tolerate different doses of the vaccine. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HydroVax-002 YFV for yellow fever because, unlike existing live-attenuated vaccines, this treatment uses an inactivated virus. This approach could potentially reduce the risk of vaccine-related complications, especially for those with weakened immune systems. Additionally, HydroVax-002 YFV is administered via intramuscular injection, which is a standard and accessible method, making it easier to integrate into vaccination programs. This inactivated vaccine could offer a safer alternative while still providing effective protection against yellow fever.

What evidence suggests that the HydroVax-002 YFV vaccine could be an effective treatment for YFV?

Research has shown that HydroVax-002 YFV might work well against yellow fever. Early results suggest that this vaccine, which does not use a live virus, can help the body produce antibodies. These antibodies prevent the virus from spreading and causing serious illness. The vaccine's design, which avoids using a live virus, aims to ensure safety and reduce the risk of side effects. Although the research remains in the early stages, the promising results indicate that HydroVax-002 YFV could help prevent yellow fever. Participants in this trial will receive either a low or high dose of HydroVax-002 YFV or a placebo, allowing researchers to evaluate its effectiveness and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

Christopher W Woods, MD, MPH

Principal Investigator

Duke Health

Emmanuel B Walter, MD, MPH

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Screening laboratories within acceptable parameters.

Negative test for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw.

Able to understand and comply with planned study procedures and be available for all study visits.

Exclusion Criteria

Have immunosuppression as a result of an underlying illness or treatment.

Use of anticancer chemotherapy or radiation therapy within 3 years prior to study vaccination.

Have known active or recently active neoplastic disease or a history of any hematologic malignancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the HydroVax-002 YFV vaccine or placebo intramuscularly on Days 1 and 29 in a two-dose series

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HydroVax-002 YFV
• Placebo

How Is the Trial Designed?

Group I: Low Dose Sentinel Experimental Treatment 2 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 Expanded Experimental Treatment 2 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 Sentinel Experimental Treatment 2 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 Expanded Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Najit Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

70+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The newly developed live-attenuated yellow fever vaccine candidate vYF-247 shows a significantly lower neurovirulence compared to existing vaccines (Stamaril and YF-VAX), suggesting it may have a safer profile with reduced risk of severe reactions like YEL-AVD and YEL-AND.

In preclinical studies, vYF-247 demonstrated strong immunogenicity and effective protection against yellow fever in animal models, indicating it could provide robust protection in humans similar to current vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next generation live-attenuated yellow fever vaccine candidate: Safety and immuno-efficacy in small animal models. Piras-Douce, F., Raynal, F., Raquin, A., et al.[2021]

The review of 276 million doses of Stamaril® vaccine shows a favorable safety profile, particularly regarding serious adverse events, which are reported at lower rates than previously estimated for yellow fever vaccines.

The findings provide valuable insights for healthcare providers, confirming that Stamaril's safety is consistent with its product characteristics, especially for at-risk groups like the elderly, pregnant women, and immunosuppressed individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of the yellow fever vaccine Stamaril®: a 17-year review. Cottin, P., Niedrig, M., Domingo, C.[2013]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10404272

A Randomized Phase I Clinical Trial of HydroVax-YFV, a ... The overall mortality rate following YFV vaccination (all ages) is estimated at 1 to 2 deaths per million doses. Despite these clear gaps in vaccination ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05172544

Trial of an Inactivated Yellow Fever Virus Vaccine The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-002 YFV vaccine administered intramuscularly in a two-dose ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666379124003690

Development of a hydrogen peroxide-inactivated vaccine ... Our results indicate that an optimized, inactivated YF vaccine elicits protective antibody responses that prevent viral dissemination and lethal infection in ...

4. withpower.com withpower.com/trial/phase-1-yellow-fever-11-2021-2ec79

Trial of an Inactivated Yellow Fever Virus Vaccine What data supports the effectiveness of the drug HydroVax-002 YFV? ... These findings suggest that HydroVax-002 YFV might also be effective against yellow fever.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9147422/

A Systematic Review and a Meta-Analysis of the Yellow ... The results obtained through the meta-analysis showed a risk of serious adverse events after yellow fever vaccination three times higher for the elderly.

6. fda.gov fda.gov/media/76015/download

YF-VAX® - Yellow Fever Vaccine Vaccination with YF-VAX is contraindicated in infants less than 9 months of age due to an increased risk of encephalitis.