NCT00694655

Human Immune Responses to Yellow Fever Vaccination

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to use the live attenuated Yellow Fever Vaccine (YFV) as a safe and effective model for viral infection to understand human immune response to viral antigens. Study participants will receive the yellow fever vaccine and participation in the study may be as short as one month or as long as one year, depending on immune responses.

Detailed description

Yellow fever (YF) is a viral disease that is transmitted to humans through the bite of an infected mosquito. Yellow fever is a life-threatening infection that can result in hepatitis, renal failure and coagulation abnormalities, and in severe cases, death. Yellow fever was a major public health threat in the colonial United States in the 18th and 19th centuries. Yellow fever is endemic in over 40 countries, and approximately 125 countries require proof of vaccination for entry by travelers at risk. An estimated 200,000 cases of yellow fever occur annually in South America and Africa, making it an important vaccine-preventable disease among travelers to endemic areas. Yellow fever can be prevented by vaccination with the Yellow Fever Vaccine. Currently, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) recommend yellow fever vaccination for persons ≥ 9 months of age who are traveling to or living in a yellow fever endemic area. The Yellow Fever Vaccine is considered to be one of the safest and most effective viral vaccines ever developed. Yellow Fever Vaccine is known to stimulate broad-spectrum immune responses, including cytotoxic T cells, and Th1 and Th2 responses, as well as neutralizing antibody titers that can persist for up to 30 years, after a single vaccination. Despite the great success of this empiric vaccine, there has been relatively little understanding of the mechanisms by which Yellow Fever Vaccine induces such robust protective immune responses. The researchers hope to apply the best contemporary methods in immunology, genomics, and proteomics to characterize in detail a successful immune response to Yellow Fever vaccination. This characterization should identify new immunologic predictors that could serve as surrogates for future vaccine efficacy studies. In addition, these findings could guide development of a safer yellow fever vaccine (or the derivation of safer alternative vaccination regimens using the currently available vaccine). This study plans to recruit both travelers to yellow fever endemic areas as well as non-travelers for participation. Healthy participants will be enrolled into four study arms. Arm enrollment is determined by Human Leukocyte Antigen (HLA) type, current needs of the lab and/or willingness to participate in sampling procedures. All participants receive Yellow Fever Vaccine on Day 0 at the FDA-approved dose and route of administration. Post-vaccination procedures are determined by arm assignment. Participants will be followed for up to 360 days post-vaccination.

Conditions

• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	Yellow Fever Vaccine	Participants receive Yellow Fever Vaccine, at the FDA approved dose and route of administration.
PROCEDURE	Leukapheresis	In leukapheresis blood is drawn and then the white blood cells are separated from the blood sample in a laboratory procedure. Once the white blood cells are returned the blood is returned back to the bloodstream of the participant who provided the sample.
PROCEDURE	Fine-needle aspiration (FNA)	In fine-needle aspiration a cell sample is collected using a needle and syringe. Fine-needle aspiration is typically used as a minimally invasive method of sample collection used to confirm a diagnosis.

Timeline

• Start date: 2008-05-01
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2008-06-10
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study