What side effects are associated with this type of intervention?

The Yellow Fever Vaccine (YFV), a live-attenuated vaccine, is generally safe but can cause side effects, particularly in older adults and those with certain health conditions. Common side effects include mild symptoms such as fever, headache, and muscle aches. However, severe adverse events, though rare, can occur, including serious allergic reactions, viscerotropic disease (similar to severe yellow fever), and neurotropic disease (affecting the nervous system). The risk of severe side effects increases with age, particularly in individuals over 60 years old. Other treatments, such as the antiviral sofosbuvir, have shown promise in animal studies but are not yet standard treatments for yellow fever in humans.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for Yellow Fever. However, several drugs have been studied for their potential efficacy against the virus. These include rifapentine, which has shown promise as an entry and replication inhibitor, and sofosbuvir, which has demonstrated significant antiviral effects in vitro and in animal models. Additionally, an adenovirus-vectored interferon, DEF201, has shown protective effects in a hamster model of Yellow Fever. These studies suggest potential therapeutic options, but none have received FDA approval to date.

What other types of research exist?

Promising novel alternatives to the traditional Yellow Fever Vaccine (YFV) include the development of multi-epitope vaccines identified through bioinformatics approaches, which aim to stimulate both humoral and cellular immune responses. Additionally, the use of the YF17D platform for developing other potent vaccines, such as a COVID-19 vaccine candidate, indicates potential for new vaccine platforms that could be adapted for Yellow Fever.

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Virus Therapy

Yellow Fever Vaccine for Yellow Fever

Phase 1 & 2

Waitlist Available

Led By Timothy Schacker, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).

Be between 18 and 65 years old

Must not have

Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells),

Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

This trial studies how well the yellow fever vaccine works in healthy adults from Uganda and Minnesota. Researchers will compare immune responses between people from areas with different levels of infection. The vaccine helps the body produce antibodies to protect against yellow fever.

Who is the study for?

This trial is for healthy adults without immune system issues who haven't had the yellow fever vaccine before. Women of childbearing age must avoid pregnancy for a month after vaccination. People with bleeding disorders, severe allergies to vaccine components, or those on immunosuppressive therapy cannot join.

What is being tested?

The study tests how the yellow fever vaccine affects lymph node structures and immunity in two groups: one from Uganda and another from Minnesota. It involves blood samples and tissue collection before and after vaccination to assess inflammation and immune response.

What are the potential side effects?

While not specified here, common side effects of the yellow fever vaccine may include mild headache, muscle pain, low-grade fever, soreness at injection site, or fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am not on any medication that weakens my immune system.

Exclusion Criteria

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

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I am immunosuppressed due to a condition like HIV, cancer, or from receiving a transplant or certain medications.

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I plan to try for a baby within 28 days of joining the study and getting the yellow fever vaccine.

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I have a thymus disorder affecting my immune system.

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I have a known bleeding disorder.

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I have undergone radiation therapy before.

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I had surgery complications due to clotting issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Peak Neutralizing Antibody Titer

Side effects data

From 2012 Phase 3 trial • 552 Patients • NCT01466387

Headache

Injection site pain

Influenza like illness

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

MenACWY-CRM197 (Combined)

JE+Rabies+MenACWY-CRM197

TF+YF+MenACWY-CRM197

JE+Rabies

Rabies

TF+YF

Trial Design

1Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

In this single-arm study, all participants will receive the intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Yellow Fever Vaccine

2016

Completed Phase 4

~1490

0 / 7Eligibility 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 Yellow Fever Vaccine (YFV) works by stimulating the immune system to produce a strong and lasting immune response against the yellow fever virus, thereby providing long-term immunity. Antiviral treatments, such as sofosbuvir, inhibit viral replication, reducing the viral load and severity of the disease. These mechanisms are vital for Yellow Fever patients as they either prevent the disease through vaccination or mitigate its impact through antiviral therapy.

Yellow fever virus is susceptible to sofosbuvir both in vitro and in vivo.Treatment of yellow fever virus with an adenovirus-vectored interferon, DEF201, in a hamster model.WITHDRAWN: Antivirals for the common cold.