Trial of an Inactivated Yellow Fever Virus Vaccine

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

26 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug HydroVax-002 YFV?

The research shows that similar antiviral compounds, like 2'-C-methylcytidine and remdesivir, have been effective in treating yellow fever in animal models. These findings suggest that HydroVax-002 YFV might also be effective against yellow fever. ^{1 2 3 4 5}

What safety data exists for HydroVax-002 YFV and similar treatments?

The yellow fever vaccine, including versions like Stamaril and YF 17D, has been widely used with a generally favorable safety profile. Serious adverse events are rare but can include severe allergic reactions and specific diseases affecting the nervous system and organs. Most people tolerate the vaccine well, but certain groups, like the elderly or those with weakened immune systems, may be at higher risk for adverse effects. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests a new vaccine called HydroVax-002 in healthy adults aged 18 to 49 years. The vaccine is given in two doses, one at the beginning and another after about a month, to see if it is safe and how people react to it. HydroVax-002 is a follow-up to HydroVax-001, which was tested for safety and effectiveness in healthy adults.

Research Team

Christopher W Woods, MD, MPH

Principal Investigator

Duke Health

Emmanuel B Walter, MD, MPH

Principal Investigator

Duke Health

Eligibility Criteria

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

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

Treatment Details

Interventions

• HydroVax-002 YFV
• Placebo

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A mouse model for studying viscerotropic disease caused by yellow fever virus infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A live, attenuated recombinant West Nile virus vaccine. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of 2'-C-methylcytidine against yellow fever virus in cell culture and in a hamster model. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Next generation live-attenuated yellow fever vaccine candidate: Safety and immuno-efficacy in small animal models. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Remdesivir efficacy against yellow fever in a hamster model. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Phenotypic and molecular analyses of yellow fever 17DD vaccine viruses associated with serious adverse events in Brazil. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Post-marketing evaluation of the short term safety of COMVAX. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events following yellow fever preventive vaccination campaigns in eight African countries from 2007 to 2010. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety profile of the yellow fever vaccine Stamaril®: a 17-year review. [2013]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Yellow fever vaccine-associated adverse events following extensive immunization in Argentina. [2014]