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Virus Therapy
Yellow Fever Vaccine Immune Response Tracking for Yellow Fever
Phase 4
Recruiting
Led By Sri Edupuganti, MD
Research Sponsored by Sri Edupuganti
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-45 years
Able to understand and give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12
Awards & highlights
Study Summary
This trial will use D20 to track YFV specific CD8+ T cells in human vaccinees who are positive for a specific HLA type, HLA A202. D20 will help us understand how long these cells live and how often they divide to create new cells. This will give us a better understanding of the immune response to live viral infections.
Who is the study for?
This trial is for adults aged 18-45 who have the HLA A202 allele and can use effective birth control. They must not travel to yellow fever areas, have no history of certain viral infections or vaccinations, no egg/chicken/gelatin allergies, and should not be immunocompromised. Pregnant or nursing women are excluded.Check my eligibility
What is being tested?
The study tests how the immune system's CD8 T cells respond to the yellow fever vaccine using deuterium-labeled water (heavy water) to track cell turnover. Participants will drink this special water after vaccination to help measure their body's reaction.See study design
What are the potential side effects?
There may be minimal side effects from drinking deuterium-labeled water as it is similar to regular water and naturally occurring in small amounts. The yellow fever vaccine could cause mild flu-like symptoms, muscle pain, headache or low-grade fever.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Select...
I understand the study and agree to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decay Curve of Effector CD8 T Cells
Decay Curve of Monocytes
Homeostatic Turnover of Memory CD8 T Cells
+2 moreSecondary outcome measures
Kinetics of B Cell Responses
Kinetics of Monocytes
Kinetics of T Cell Responses
+5 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Group 4b - Drink deuterated water for 7 days without vaccinationExperimental Treatment1 Intervention
To assess homeostatic turnover of monocytes participants in group 4b, unvaccinated participants will will be asked to drink deuterium (70% enriched 2H2O) labeled water for 7 days post enrollment.
Group II: Group 4a - Drink deuterated water on days 0 - 7 post-vaccination, with fine needle aspirateExperimental Treatment2 Interventions
To assess homeostatic turnover of monocytes participants in group 4a will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water on Days 0 through 7 post-vaccination. Participants will undergo two fine needle aspirate (FNA) procedures to examine the immune response in the lymph nodes.
Group III: Group 3 - Drink deuterated water for up to 8 weeks without vaccinationExperimental Treatment1 Intervention
To assess homeostatic turnover of CD8+ T lymphocytes in general, unvaccinated participants will be asked to drink deuterium (70% enriched 2H2O) labeled water for up to 8 weeks.
Group IV: Group 2b - Drink deuterated water 6 months post-vaccinationExperimental Treatment2 Interventions
To assess the homeostatic proliferation of Memory CD8 T cells, participants in group 2b will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water 6 months post-vaccination.
Group V: Group 2a - Drink deuterated water 2 months post-vaccinationExperimental Treatment2 Interventions
To assess the homeostatic proliferation of Memory CD8 T cells, participants in group 2a will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water 2 months post-vaccination.
Group VI: Group 1c - Drink deuterated water on days 0 - 28 post-vaccinationExperimental Treatment2 Interventions
Participants testing positive for HLA-A2 will be enrolled into one of the three Group 1 study arms. To assess the life span and decay of effector CD8+T cells, participants in group 1c will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water for 4 weeks, on Days 0 through 28 post-vaccination.
Group VII: Group 1b - Drink deuterated water on days 14 - 28 post-vaccinationExperimental Treatment2 Interventions
Participants testing positive for HLA-A2 will be enrolled into one of the three Group 1 study arms. To assess the life span and decay of effector CD8+T cells, participants in group 1b will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water for 2 weeks, on Days 14 through 28 post-vaccination.
Group VIII: Group 1a - Drink deuterated water on days 0 - 14 post-vaccinationExperimental Treatment2 Interventions
Participants testing positive for human leukocyte antigen-A2 (HLA-A2) will be enrolled into one of the three Group 1 study arms. To assess the life span and decay of effector CD8+T cells, participants in group 1a will receive the 17D yellow fever vaccine and will be asked to drink deuterium (70% enriched 2H2O) labeled water for 2 weeks, on Days 0 through 14 post-vaccination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yellow fever vaccine
FDA approved
Find a Location
Who is running the clinical trial?
Sri EdupugantiLead Sponsor
Sri Edupuganti, MD MPHLead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,934 Total Patients Enrolled
8 Trials studying Yellow Fever
822 Patients Enrolled for Yellow Fever
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received blood products or immune globulin within the last 42 days, except for COVID monoclonal antibodies.I do not have an active Hepatitis B or C infection.I had COVID-19 but fully recovered over 30 days ago.I am HLA-A2 positive (not for Group 3 or 4).I have a chronic condition like diabetes or heart disease, or I've used immunosuppressants recently.I have a history of HIV infection.I have a history of thymus gland issues or autoimmune disorders.I have a history of neurological or neurodegenerative disorders.I am between 18 and 45 years old.I agree not to take live vaccines around the time of my trial participation.I am using birth control and can provide a negative pregnancy test, or I am not able to have children due to surgery or menopause.I have received a yellow fever vaccine (not applicable for Group 2).I have a condition that weakens my immune system, but not skin cancer or cured non-lymphatic tumors.I understand the study and agree to participate.I am not pregnant, nursing, nor planning to become pregnant during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4a - Drink deuterated water on days 0 - 7 post-vaccination, with fine needle aspirate
- Group 2: Group 1a - Drink deuterated water on days 0 - 14 post-vaccination
- Group 3: Group 1c - Drink deuterated water on days 0 - 28 post-vaccination
- Group 4: Group 3 - Drink deuterated water for up to 8 weeks without vaccination
- Group 5: Group 2a - Drink deuterated water 2 months post-vaccination
- Group 6: Group 4b - Drink deuterated water for 7 days without vaccination
- Group 7: Group 2b - Drink deuterated water 6 months post-vaccination
- Group 8: Group 1b - Drink deuterated water on days 14 - 28 post-vaccination
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this research confined to individuals over 45?
"To qualify for this research, participants should be aged 18 to 45. However, there are 26 trials available for minors and 70 clinical studies designed specifically with elderly patients in mind."
Answered by AI
Are there any preconditions for enrolling in this trial?
"Prospective members of this trial must have a yellow fever diagnosis and meet the age requirement between 18 to 45. A total of 40 participants are needed for enrolment into the study."
Answered by AI
How many subjects are currently receiving treatment through this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical investigation is actively looking for participants, having initially been posted on February 1st 2011 and recently updated on May 17th 2022. 40 patients are required from two separate medical centres in order to fill the trial's requirements."
Answered by AI
How reliable is Deuterium (70% enriched 2H2O) labeled water for medical applications?
"There is considerable evidence supporting the safety of deuterium (70% enriched 2H2O) labelled water, thus it has been assigned a score of 3 reflecting its approval in Phase 4 trials."
Answered by AI
Are enrollees being accepted for this experiment presently?
"According to clinicaltrials.gov, recruitment for this trial is currently taking place. It was initially posted on February 1st 2011 and the information was updated as recently as May 17th 2022."
Answered by AI
What past experiments have utilized Deuterium (70% enriched 2H2O) labeled water?
"Presently, 7 studies are being conducted investigating Deuterium (70% enriched 2H2O) labeled water. None of these active investigations have reached Phase 3. The many Madrid, Comunidad De-based trials for this therapy also span 59 clinical sites across the globe."
Answered by AI
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