Systems Investigation of Vaccine Responses in Aging and Frailty

NCT05291676 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2000035834U19AI0899920409027018
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the immune response signatures (including immunologic, transcriptomic and metabolomic) of the two influenza vaccines approved for use in adults age 65 and over (Fluad and Fluzone High-Dose).

Conditions

Influenza

Keywords

vaccine; influenza vaccine; older adults; vaccine response; toll-like receptors; immune response

Outcome Measures

Primary Outcomes (1)

• Change in production of IL-6 in monocytes to assess innate immune inflammatory response

  Measurement of IL-6 production in monocytes via flow cytometry

  Baseline and at Day 2, 7, and 28 post-vaccine

Secondary Outcomes (5)

• Change in Hemagglutination inhibition titer (HAI) in response to vaccination

  Baseline and Day 28

• Change in transcriptomic analyses of gene expression

  At Baseline, Day 2, Day 7, Day 28 and Day 70

• Change in proteomic analyses

  At Baseline, Day 2, Day 7, Day 28 and Day 70

• Number of participants with changes in innate immune function from PBMCs and PRP as assessed using flow cytometry

  At Baseline, Day 2, Day 7, Day 28 and Day 70

• Number of participants with changes in B and T cell function from PBMCs as assessed using flow cytometry

  At Baseline, Day 2, Day 7, Day 28 and Day 70

Study Arms (4)

21-30 standard dose Fluad

ACTIVE COMPARATOR

Participants age 21-30 years will receive the standard dose Fluad

Biological: Fluad

21-30 high dose Fluzone

ACTIVE COMPARATOR

Participants age 21-30 years will receive the high dose Fluzone

Biological: Fluzone

≥65 years standard dose Fluad

EXPERIMENTAL

Participants age ≥65 years will receive standard dose Fluad

Biological: Fluad

≥65 years high dose Fluzone

EXPERIMENTAL

Participants age ≥65 years will receive high dose Fluzone

Biological: Fluzone

Interventions

Fluzone BIOLOGICAL

Fluzone High-Dose 0.7 ml intramuscular injection, standard as recommended by manufacturer

21-30 high dose Fluzone; ≥65 years high dose Fluzone

Fluad BIOLOGICAL

Fluad Quadrivalent, MF59 adjuvanted 0.5 ml intramuscular injection, standard as recommended by manufacturer

21-30 standard dose Fluad; ≥65 years standard dose Fluad

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-40 or 65 and older
• Ability to understand and give informed consent (surrogate consent may apply to nursing home subjects who are decisionally impaired, with verbal assent to be obtained from subject)
• Plan to be in the New Haven, CT area for the next 4-6 weeks

You may not qualify if:

• Current use of medication, such as antibiotics in past two weeks. To clarify, patients taking antibiotics for the reason of a current acute infection will not be eligible. Those potential participants receiving antibiotics for prophylaxis purposes will be eligible to participate. The intention is not to create a separate group to drawn conclusions, but not to exclude these participants who are not acutely ill.
• Evidence of acute infection, identified by self- report of fever or symptoms in past two weeks
• Treatment for cancer in past three months.
• Previous adverse reaction to influenza vaccine requiring medical attention, such as allergic response (rash, anaphylaxis) or Guillain-Barré syndrome.
• Pregnant/possibly pregnant.
• History of organ, bone marrow or stem cell transplant, liver cirrhosis, kidney disease requiring dialysis, HIV/AIDS, hepatitis C or active hepatitis B
• Blood donation of 1 pint or more in past 2 months
• Treatment with clinical trial medication
• Presence of any other condition (e.g., geographical or social), actual or projected, that the investigator feels would restrict or limit the patient's participation for the duration of the study. This provision includes participants who have 50% or more missed appointments in the last three months.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; fluad vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Albert Shaw, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Matos, RN

CONTACT

(203) 737-4739; irene.matos@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 23, 2022
• Study Start: November 6, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)