Yellow Fever Vaccine for Yellow Fever

Recruiting at 1 trial location

Overseen By Kevin Escandon, MD, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Minnesota

Must not be taking: Immunosuppressants, Corticosteroids, TNF inhibitors, others

Disqualifiers: Yellow fever history, Bleeding disorder, Immunosuppression, others

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

Compensation: Varies

Number of Visits: Unknown

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on immunosuppressive drugs, you may not be eligible to participate.

Is the yellow fever vaccine generally safe for humans?

The yellow fever vaccine is considered one of the safest and most effective vaccines, but rare serious side effects can occur, such as neurologic or viscerotropic syndromes (affecting the nervous system or internal organs) and anaphylaxis (a severe allergic reaction). Older adults, pregnant women, and people with weakened immune systems may be at higher risk for these adverse events. ^{1 2 3 4 5}

How is the Yellow Fever Vaccine different from other treatments for yellow fever?

The Yellow Fever Vaccine is unique because it is a live attenuated vaccine, meaning it uses a weakened form of the virus to stimulate immunity without causing the disease. Unlike other treatments, which may not exist for yellow fever, this vaccine provides long-term protection and is administered either intramuscularly or subcutaneously, offering flexibility in how it can be given. ^{6 7 8 9 10}

What data supports the effectiveness of the yellow fever vaccine treatment for yellow fever?

The yellow fever vaccine has been effectively used for over 70 years to prevent yellow fever, and it is considered one of the safest and most effective vaccines available. Millions of doses are administered each year, highlighting its essential role in protecting against the disease. ^{1 11 12 13 14}

Who Is on the Research Team?

Timothy Schacker, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

If female of childbearing age must agree to contraception for one month following administration of the vaccination.

Exclusion Criteria

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

You have a mental or behavioral disorder that could make it hard for you to finish the study, as determined by the investigator.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Vaccination Assessment

Participants undergo lymph node and adipose tissue biopsy and leukapheresis before vaccination

1 week

Vaccination

Participants receive the yellow fever vaccine

1 day

Post-Vaccination Assessment

Participants undergo a second lymph node biopsy and leukapheresis 3 weeks after vaccination

3 weeks

Follow-up

Participants are monitored for safety and effectiveness, with regular collection of PBMC, plasma, urine, and stool over 18 months

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Yellow Fever Vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

Elderly individuals (ages 60-81) showed a delayed immune response to the yellow fever vaccine (YF-17D), with only 50% achieving seroprotection by day 10 compared to 77% of younger participants (ages 18-28).

Higher levels of viraemia were observed in the elderly, with 86% showing detectable YF-17D RNA, suggesting that a weaker immune response may increase the risk of serious adverse events following vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elderly subjects have a delayed antibody response and prolonged viraemia following yellow fever vaccination: a prospective controlled cohort study. Roukens, AH., Soonawala, D., Joosten, SA., et al.[2022]

Both the 17D-204 and 17DD substrains of the yellow fever vaccine induce strong cellular and humoral immune responses, demonstrating similar immunogenicity, which is crucial for effective protection against yellow fever.

The adverse effects of both vaccines are mostly mild, indicating that they are safe options for vaccination, especially important given the recent re-emergence of yellow fever in certain regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 17D-204 and 17DD yellow fever vaccines: an overview of major similarities and subtle differences. Ferreira, CC., Campi-Azevedo, AC., Peruhype-Magalhāes, V., et al.[2019]

The study involving 60 healthy adults demonstrated that the new Yellow Fever vaccine (SII YFV) is safe and immunogenic, with no serious adverse events reported and a high seroconversion rate of 94.44% for subcutaneous and 100% for both intramuscular and STAMARIL® groups.

Solicited reactions were relatively low, with 10% for SII YFV SC, 40% for SII YFV IM, and 25% for STAMARIL®, indicating that the new vaccine has a favorable safety profile compared to existing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine. Desai, S., Anil, K., Potey, AV., et al.[2022]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Is it time for a new yellow fever vaccine? [2010]

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

Yellow Fever Immunizations: Indications and Risks. [2020]

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

Intradermally administered yellow fever vaccine at reduced dose induces a protective immune response: a randomized controlled non-inferiority trial. [2021]

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

Safe administration of yellow fever vaccine in patients with suspected egg allergy. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Successful immunization of an allogeneic bone marrow transplant recipient with live, attenuated yellow Fever vaccine. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated with severity of adverse events following yellow fever vaccination during the biggest outbreak of the disease recorded in Brazil, 2016-2017. [2021]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Reporting rates of yellow fever vaccine 17D or 17DD-associated serious adverse events in pharmacovigilance data bases: systematic review. [2019]

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

Elderly subjects have a delayed antibody response and prolonged viraemia following yellow fever vaccination: a prospective controlled cohort study. [2022]

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

The safety of yellow fever vaccine 17D or 17DD in children, pregnant women, HIV+ individuals, and older persons: systematic review. [2021]

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

Pre-clinical efficacy and safety of experimental vaccines based on non-replicating vaccinia vectors against yellow fever. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The 17D-204 and 17DD yellow fever vaccines: an overview of major similarities and subtle differences. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Yellow fever-associated viscerotropic disease in Barcelona, Spain. [2020]

13. England pubmed.ncbi.nlm.nih.gov

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Current status of the Arilvax; yellow fever vaccine. [2007]