What side effects are associated with this type of intervention?

The most common side effects of Yellow Fever vaccines, such as the YF-VAX, include mild local reactions at the injection site (e.g., erythema, pain, or swelling), fever, headache, and fatigue. Serious adverse events are rare but can include hypersensitivity reactions and, in very rare cases, neurological complications such as Guillain-Barré syndrome. These side effects are generally consistent with those observed in prelicensure clinical trials and post-licensure surveillance studies.

What prior FDA approvals exist?

The FDA has previously approved the YF-VAX vaccine for the prevention of Yellow Fever. YF-VAX works by inducing an immune response that stimulates the production of antibodies against the yellow fever virus. This is similar to the investigational yellow fever vaccine (vYF) being studied, which also aims to stimulate an immune response to protect against the virus. Both vaccines are designed to provide immunity by promoting the body's natural defense mechanisms.

What other types of research exist?

A promising novel alternative to vYF for Yellow Fever patients in 2024 is the investigational yellow fever vaccine being compared to YF-VAX. This investigational vaccine has shown a comparable immune response and safety profile to YF-VAX in clinical studies.

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Virus Vaccine

Investigational Yellow Fever Vaccine vs Standard Vaccine for Yellow Fever (VYF02 Trial)

Phase 2

Waitlist Available

Research Sponsored by Sanofi Pasteur, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.

Aged 18 years to 60 years on the day of inclusion

Must not have

Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia).

Receipt of immune globulins, blood, or blood-derived products in the past 6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 11, day 29, month 6, year 1, year 2, year 3, year 4, and year 5

Awards & highlights

Summary

This trial is testing a new yellow fever vaccine (vYF) against an existing one (YF-VAX) in people who have never been vaccinated for yellow fever. The goal is to see if the new vaccine can effectively trigger the immune system to produce antibodies, similar to the existing vaccine. YF-VAX is a well-established yellow fever vaccine that has been shown to be effective in producing protective antibodies.

Who is the study for?

Adults aged 18-60 in the USA who've never had yellow fever or a vaccine against it can join. Women must not be pregnant/breastfeeding, use contraception, and have negative pregnancy tests before/during the study. Participants should be free of certain infections, immune conditions, and not taking specific medications.

What is being tested?

The trial is testing a new yellow fever vaccine made with Vero cells against the standard YF-VAX. It measures if people's bodies respond similarly to both vaccines by looking at antibodies after 28 days and monitors safety over time.

What are the potential side effects?

Potential side effects aren't detailed here but will compare how participants react to each vaccine regarding general health disturbances that could include typical vaccine reactions like soreness, redness at injection site, fever or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not able to have children because I am postmenopausal for over a year or have been surgically sterilized.

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I am between 18 and 60 years old.

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I am not pregnant or breastfeeding, and I cannot have children due to menopause or surgery.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I or someone in my family has had issues with the thymus.

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I have received blood products or immune globulins in the last 6 months.

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I have had a flavivirus infection before.

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I have been vaccinated against diseases like yellow fever.

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I have a history of hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 11, day 29, month 6, year 1, year 2, year 3, year 4, and year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 11, day 29, month 6, year 1, year 2, year 3, year 4, and year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 11, day 29, month 6, year 1, year 2, year 3, year 4, and year 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants with seroconversion to YF virus at Day 29

Secondary study objectives

Number of participants with immediate adverse events

Number of participants with out-of-range biochemistry and hematology test results

Number of participants with related serious adverse events and deaths

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: vYFExperimental Treatment1 Intervention

1 injection of vYF at Day 1

Group II: YF-VAXActive Control1 Intervention

1 injection of YF-VAX at Day 1

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Yellow Fever, particularly vaccines like vYF and YF-VAX, work by inducing an immune response that stimulates the production of antibodies against the yellow fever virus. This mechanism is essential for Yellow Fever patients as it helps the body recognize and combat the virus, thereby providing immunity and significantly reducing the risk of severe disease and complications.

Response to Dengue virus infections altered by cytokine-like substances from mosquito cell cultures.