All > Influenza

Flu Vaccine (Year 3) for Dendritic Cell

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
UConn Health, Center On Aging, Farmington, CTDendritic Cell+3 MoreFlu Vaccine (Year 3) - Biological
Eligibility
65+
All Sexes
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Study Summary

This trial will study 66 seniors over 3 years to understand why the flu vaccine is less effective in older adults. Blood, nasal, and stool samples will be collected at 16 study visits.

Eligible Conditions
  • Flu Vaccine, Flu
  • Aging
  • Dendritic Cell
  • Vaccine Response

Treatment Effectiveness

Effectiveness Progress

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

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Study Objectives

3 Primary · 12 Secondary · Reporting Duration: Baseline, Day1, Day 7, Day 35, Day 180

Day 7
Number of genes upregulated in response to Influenza Vaccine in Year Two
Day 180
Change in Antibody Responses to Influenza Vaccine Year One
Change in Antibody Responses to Influenza Vaccine Year Three
Change in Antibody Responses to Influenza Vaccine Year Two
Day 35
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year One
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Three
Evaluate changes in functional status of immune cells in response to Influenza Vaccine in Year Two
Baseline, Day1, Day 7
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year One
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Three
Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Two
Number of genes upregulated in response to Influenza Vaccine in Year One
Number of genes upregulated in response to Influenza Vaccine in Year Three
Day 180
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year One
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Three
Changes in number of cDCs, Tfh, Th10, and B lymphocytes in response to Influenza Vaccine in Year Two

Trial Safety

Safety Progress

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

Similar Trials

1
Tolerogenic Dendritic Cell Vaccine
1
TH-1 Dendritic Cell Immunotherapy
1
mRNA NA vaccine

Trial Design

1 Treatment Group

Healthy Older Adults
1 of 1

Experimental Treatment

66 Total Participants · 1 Treatment Group

Primary Treatment: Flu Vaccine (Year 3) · No Placebo Group · Phase 4

Healthy Older AdultsExperimental Group · 3 Interventions: Flu Vaccine (Year 2), Flu Vaccine (Year 3), Flu Vaccine (Year 1) · Intervention Types: Biological, Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day1, day 7, day 35, day 180

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiOTHER
789 Previous Clinical Trials
484,456 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
997 Previous Clinical Trials
1,341,889 Total Patients Enrolled
UConn HealthOTHER
199 Previous Clinical Trials
58,337 Total Patients Enrolled
University of ChicagoOTHER
935 Previous Clinical Trials
754,068 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,165 Previous Clinical Trials
4,936,955 Total Patients Enrolled
The Jackson LaboratoryLead Sponsor
4 Previous Clinical Trials
1,659 Total Patients Enrolled
George Kuchel, MD, FRCPPrincipal InvestigatorUConn Center on Aging

Eligibility Criteria

Age 65+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You agree to let us test your biological samples and share the results anonymously at the end of the study.
References

Frequently Asked Questions

What is the chief aim of this research endeavor?

"The primary purpose of this investigation, which will be assessed over the course of Baseline, Day 35 and Day 180 is to assess Change in Antibody Responses to Influenza Vaccine Year Three. Additionally, secondary objectives include establishing the Number of chromatin accessibility regions activated in response to Influenza Vaccine in Year Two and Year Three using snATAC-seq as well as determining how many genes are upregulated by both FLUAD and CDC recommended FDA approved influenza vaccinations via RNA-seq and scRNA-seq respectively." - Anonymous Online Contributor

Unverified Answer

What is the sample size of participants involved in this research?

"That is correct. According to clinicaltrials.gov, this research project has been ongoing since August 31st 2022 and is still recruiting participants as of September 15th 2022. 66 individuals are sought from a single site for the trial." - Anonymous Online Contributor

Unverified Answer

To what extent is Year 3 of the Flu Vaccine detrimental to those receiving it?

"The safety of Year 3 Flu Vaccine was given a rating of 3 due to the various clinical trials that have approved this treatment." - Anonymous Online Contributor

Unverified Answer

Are there any unfilled slots in this clinical experiment?

"Clinical trials.gov confirms that this clinical research is presently recruiting participants, having been first posted on August 31st 2022 and last modified September 15th 2022." - 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.

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