Turnover of Antigen Specific Lymphocytes After Immunization With the 17D Yellow Fever Vaccine

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The yellow fever vaccine is a live, attenuated virus that results in a robust immune response, especially in the T cell compartment. We have been studying immune responses to live viral infections using the yellow fever vaccine as a model for a live viral infection. In this study, we are interested in looking at the processing and lifespan of yellow fever specific CD8 T cells. We plan to accomplish this by measuring DNA replication and cell proliferation in humans using a naturally occurring stable isotope called deuterium (D20). This technique has been used to track the turnover of a number of human cell types in vivo. We plan to use D20 labeling to track YFV specific CD8+ T cells in human vaccinees who are positive for a specific HLA type, HLA A202. Deuterium labeled water (D2O), also known as heavy water is physically and chemically very similar to ordinary drinking water. In water, two hydrogen atoms bond to an oxygen and create H20. However in deuterated water, deuterium atoms replace the hydrogen atoms. Deuterium is a form of hydrogen that has an extra neutron. This neutron gives the atom extra weight, hence the name heavy water. This extra weight can be detected in the lab with very sensitive instruments. Scientists have been using heavy water as a tracer to gain a better understanding of animal and human metabolic rates. Deuterium is in fact already in the water we drink daily. It is not radioactive, and it occurs naturally at a concentration of about 1 part per 5,000. Researchers have used heavy water since 1934 as a safe and effective tool in clinical trials.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Able to understand and give informed consent

• Age 18-45 years

• Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) yellow fever vaccination

• Women of child bearing potential must agree to use effective birth control for the entire duration of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to the initiation of drinking deuterium labeled water.

• Must be positive for the HLA A202 allele

• Must agree not to receive any other vaccination during the labeling period with heavy water and in the first 28 days after receipt of yellow fever vaccination

Locations
United States
Georgia
The Hope Clinic of Emory Vaccine Center
Recruiting
Decatur
Contact Information
Primary
Eileen Osinski
gosinsk@emory.edu
404-727-8435
Backup
Shashi Nagar
shashi.nagar@emory.edu
404-712-1407
Time Frame
Start Date: February 2011
Estimated Completion Date: April 2024
Participants
Target number of participants: 40
Treatments
Experimental: Group 1 - Yellow fever vaccine and deuterated water for two weeks
In group 1, participants will receive the Yellow fever vaccine or YFV-17D and will be asked to drink Deuterium (70% enriched 2H2O) labeled water for 2 weeks (Days 14 to 28 post-vaccination). They will undergo phlebotomy on Day 0, 14, 28 and 3 to 6 months, 1-2 years and >5 years after vaccination.
Experimental: Group 2a - Yellow fever vaccine and deuterated water for three weeks
In group 2, participants will receive the Yellow fever vaccine or YFV-17D and will be asked to drink Deuterium (70% enriched 2H2O) labeled water for 3 weeks. They will undergo phlebotomy on Day 0, 14, 28 and 3 to 6 months, 1-2 years and >5 years after vaccination.~In group 2a, phlebotomies will occur at weekly at 8, 9, 10, 11,12, 14 and 20 weeks post vaccination~Participants in Group 2a will begin drinking deuterated water at month 2~Participants will drink 2H2O 50ml TID for the first week, then 50ml BID for 3 weeks.~In group 2b, phlebotomies will occur weekly at 24, 25, 26, 27, and 28 post vaccination.
Experimental: Group 2b - Yellow fever vaccine and deuterated water for three weeks
In group 2, participants will receive the Yellow fever vaccine or YFV-17D and will be asked to drink Deuterium (70% enriched 2H2O) labeled water for 3 weeks. They will undergo phlebotomy on Day 0, 14, 28 and 3 to 6 months, 1-2 years and >5 years after vaccination.~Participants in Group 2b will begin drinking deuterated water at month 6~Participants will drink 2H2O 50ml TID for the first week, then 50ml BID for 3 weeks.
Sponsors
Collaborators: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), University of California, Berkeley
Leads: Sri Edupuganti

This content was sourced from clinicaltrials.gov

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