Deuterium (70% enriched 2H2O) labeled water for Yellow Fever

The Hope clinic of Emory Vaccine Center, Decatur, GA
Yellow FeverDeuterium (70% enriched 2H2O) labeled water - Other
Eligibility
18 - 45
All Sexes

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.

Eligible Conditions
  • Yellow Fever

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: CD8 T cells will be measured on Day 0, 14, 28 and 3 to 6 months, 1-2 years and >5 years after vaccination.

Year 5
Tracking of deuterium labeled CD28+/- subsets of tetramer positive yellow fever specific CD8 T cells
Turnover rates of DCs and monocytes in response to YFV-17D vaccination using D20

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

5 Treatment Groups

Group 2a - Yellow fever vaccine and deuterated water for three weeks
1 of 5
Group 1 - Yellow fever vaccine and deuterated water for two weeks
1 of 5
Group 1
1 of 5
Group 2
1 of 5
Group 2b - Yellow fever vaccine and deuterated water for three weeks
1 of 5

Experimental Treatment

40 Total Participants · 5 Treatment Groups

Primary Treatment: Deuterium (70% enriched 2H2O) labeled water · No Placebo Group · Phase 4

Group 2a - Yellow fever vaccine and deuterated water for three weeksExperimental Group · 2 Interventions: Deuterium (70% enriched 2H2O) labeled water, Yellow fever vaccine · Intervention Types: Other, Biological
Group 1 - Yellow fever vaccine and deuterated water for two weeksExperimental Group · 2 Interventions: Deuterium (70% enriched 2H2O) labeled water, Yellow fever vaccine · Intervention Types: Other, Biological
Group 1Experimental Group · 2 Interventions: Deuterium (70% enriched 2H2O) labeled water, Yellow fever vaccine or YFV-17D · Intervention Types: Other, Biological
Group 2Experimental Group · 2 Interventions: Deuterium (70% enriched 2H2O) labeled water, Yellow fever vaccine or YFV-17D · Intervention Types: Other, Biological
Group 2b - Yellow fever vaccine and deuterated water for three weeksExperimental Group · 2 Interventions: Deuterium (70% enriched 2H2O) labeled water, Yellow fever vaccine · Intervention Types: Other, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yellow fever vaccine
2011
Completed Phase 3
~1570

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cd8 t cells will be measured on day 0, 14, 28 and 3 to 6 months, 1-2 years and >5 years after vaccination.

Who is running the clinical trial?

Sri Edupuganti, MD MPHLead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
Sri EdupugantiLead Sponsor
University of California, BerkeleyOTHER
160 Previous Clinical Trials
598,660 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,612,552 Total Patients Enrolled
1 Trials studying Yellow Fever
200 Patients Enrolled for Yellow Fever
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,186 Previous Clinical Trials
4,982,069 Total Patients Enrolled
8 Trials studying Yellow Fever
775 Patients Enrolled for Yellow Fever
Srilatha Edupuganti, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
374 Total Patients Enrolled
1 Trials studying Yellow Fever
300 Patients Enrolled for Yellow Fever

Eligibility Criteria

Age 18 - 45 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.