New Yellow Fever Vaccine for Vaccination Reaction

Not currently recruiting at 6 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

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

Disqualifiers: Immunodeficiency, HIV, Hepatitis B/C, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new yellow fever vaccine, vYF, compared to the existing YF-VAX vaccine. The study aims to determine if the new vaccine is as safe or safer for healthy adults who have not previously received a yellow fever vaccine. Participants will receive one dose of either vaccine and will be monitored for about six months. It suits individuals aged 18 to 60 who are healthy and have not been vaccinated against yellow fever. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, long-term corticosteroids, or have received any vaccines or antivirals recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the new vaccine, vYF, triggers an immune response similar to the approved yellow fever vaccine, YF-VAX. Earlier studies indicate that reactions to yellow fever vaccines like YF-VAX are usually mild, such as headaches, muscle aches, and low fevers. However, rare reports of more serious reactions have occurred, potentially leading to illness.

For the new vYF vaccine, available data suggests it is generally well-tolerated, much like YF-VAX, with most people experiencing only mild side effects. These findings, based on past research, help clarify the safety of the new vaccine in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the vYF vaccine because it offers a promising new approach to preventing yellow fever. Unlike the standard YF-VAX vaccine, which has been the go-to option, vYF is being tested for its potential to provoke a stronger immune response with just a single dose. This could mean better protection for individuals, especially in areas where yellow fever is prevalent. Additionally, the vYF vaccine might offer improved safety or fewer side effects, making it a standout candidate in the fight against this infectious disease.

What evidence suggests that this trial's vaccines could be effective for yellow fever?

Research has shown that the new yellow fever vaccine, vYF, is promising. In this trial, participants will receive either the vYF vaccine or the YF-VAX vaccine. Studies suggest that vYF offers strong protection against yellow fever, similar to current vaccines. Earlier research demonstrated that this vaccine triggered a strong immune response, comparable to approved vaccines. Another study found that a single dose of yellow fever vaccines is usually very effective, with most people staying protected for many years. These findings suggest that vYF could be a strong option for preventing yellow fever. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 18 to 60 years old are eligible for this trial, which compares the safety of a new yellow fever vaccine (vYF) against an already licensed one (YF-VAX). Participants must be healthy and have not previously received a yellow fever vaccine.

Inclusion Criteria

Able to attend all scheduled visits and to comply with all study procedures Informed consent

Informed consent form has been signed and dated

I am between 18 and 60 years old.

Exclusion Criteria

Known systemic hypersensitivity to study intervention components or history of life-threatening reactions to specific vaccines

Substance abuse that might interfere with study conduct or completion

Previous vaccination against specific diseases with investigational or marketed vaccines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of vYF or YF-VAX vaccine subcutaneously

1 day

1 visit (in-person) on Day 01

Follow-up

Participants are monitored for adverse events and safety outcomes

6 months

1 visit (in-person) on Day 29, 2 telephone calls on Day 15 and Month 6

What Are the Treatments Tested in This Trial?

Interventions

• vYF
• YF-VAX

Trial Overview The study is testing the safety of two yellow fever vaccines: vYF, which is investigational, and YF-VAX, which is currently licensed. Each participant will receive one dose subcutaneously and will be monitored over six months with visits and phone calls.

How Is the Trial Designed?

Group I: vYF vaccine Experimental Treatment 1 Intervention

A single dose on Day 01

Group II: YF-VAX vaccine Active Control 1 Intervention

A single dose on Day 01

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8047865/

Next generation live-attenuated yellow fever vaccine ... Our data suggests that vYF-247 would provide robust protection against YF disease in humans, similar to currently marketed YF vaccines.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309924004067

Safety and immunogenicity of a next-generation live ... A next-generation live-attenuated yellow fever vaccine candidate (vYF), produced in a Vero cell line has shown similar immunogenicity to licensed yellow fever ...

3. thelancet.com thelancet.com/journals/langlo/article/PIIS2214-109X(23)00556-9/fulltext

Long-term immunity following yellow fever vaccination Pooled seroprotection rates were 94% (95% CI 86–99) among healthy adults in a non-endemic setting (mostly travellers) and 76% (65–85) in an ...

4. cdc.gov cdc.gov/acip/grade/yf-vac-boost.html

Grading of Recommendations, Assessment, Development ... A primary dose of YF vaccine is effective with very few vaccine failures documented and most (92%) of vaccine recipients maintaining ...

5. nature.com nature.com/articles/s41541-020-0205-6

Review of data and knowledge gaps regarding yellow ... At ≥10 years post-vaccination, the rates of seropositivity were generally lower ranging from 67% to 88% using PRNT50–PRNT90, except for a small ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4635904/

Serious adverse events associated with yellow fever vaccine Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease.

7. cdc.gov cdc.gov/yellow-fever/hcp/vaccine/index.html

Yellow Fever Vaccine Information for Healthcare Providers Reactions to yellow fever vaccine are generally mild and include headaches, myalgias, and low-grade pyrexia. There have been reports of rare but ...

8. fda.gov fda.gov/media/76015/download

YF-VAX® - Yellow Fever Vaccine (See CONTRAINDICATIONS and ADVERSE REACTIONS sections.) Adverse reactions to YF-VAX include mild headaches, myalgia, low-grade fevers, or other minor symptoms ...

9. who.int who.int/groups/global-advisory-committee-on-vaccine-safety/topics/yellow-fever-vaccines/safety

Safety Altogether, 14 (61%) of the 23 cases have been fatal. All cases were reported after the primary yellow fever vaccination. Recent risk estimates for yellow fever ...