Systems Investigation of Vaccine Responses in Aging and Frailty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gene Signatures of Influenza Vaccine Responses in Older Adults

NCT03603509

Influenza

COMPLETED PHASE4

Elderly Influenza Vaccine Immunogenicity Substudy

NCT00170482

Influenza

COMPLETED

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

NCT05518500

Aging Influenza Vaccine Dendritic Cell +1 more

RECRUITING PHASE4

FLUAD® vs. Fluzone® High-Dose Study

NCT03183908

Pain Quality of Life Injection Site Reaction +2 more

COMPLETED PHASE4

Cell Mediated Immunity in Older Adults

NCT01189123

Immunity to Influenza Vaccine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There are two vaccines currently approved for use in adults age 65 and greater: a high-dose (HD) influenza vaccine (Fluzone High-Dose) that contains 4 times the hemagglutinin dose found in the standard vaccine, and a standard-dose (SD) vaccine containing the proprietary MF59 adjuvant (Fluad). Both vaccines give significantly highly antibody responses to influenza in older adults. This study will directly compare the HD and SD vaccines in nursing home residents, the population of older adults most vulnerable to influenza outbreaks and morbidity and mortality. It will comprehensively study the innate and adaptive response to vaccination, as well as elucidate transcriptomic and proteomic signatures of vaccine response.

This is a randomized, open label study comparing the two vaccines currently approved for use in adults age ≥ 65 years: the high-dose influenza vaccine and the MF59 adjuvanted standard-dose vaccine, both quadrivalent. The young group will be comprised of individuals 21-30 years of age, and the older cohorts will consist of nursing home residents ≥65 years. Participants will also be evaluated for evidence of influenza-like illness (ILI). ILI is defined to include clinical presentation in older adults: by the presence of either two respiratory symptoms (cough, sore throat, shortness of breath, and nasal stuffiness) or one respiratory and one systemic symptom (headache, malaise, temperature \>99° F, report of feverishness and muscle aches, or altered mental status). Diagnoses of influenza will be confirmed using a real-time polymerase chain reaction (PCR) test on a nasopharyngeal (NP) swab specimen done by the hospital Virology Laboratory and facilitated by the participating medical directors.

Although this is neither an efficacy or effectiveness study, participants will be randomized 1:1 to either the high-dose influenza vaccine or the MF59 vaccine within age strata. This will ensure a non-biased allocation of the two vaccines and attempts to balance participant characteristics within age strata.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

21-30 standard dose Fluad

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

Group Type ACTIVE_COMPARATOR

Fluad

Intervention Type BIOLOGICAL

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

21-30 high dose Fluzone

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

Group Type ACTIVE_COMPARATOR

Fluzone

Intervention Type BIOLOGICAL

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

≥65 years standard dose Fluad

Participants age ≥65 years will receive standard dose Fluad

Group Type EXPERIMENTAL

Fluad

Intervention Type BIOLOGICAL

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

≥65 years high dose Fluzone

Participants age ≥65 years will receive high dose Fluzone

Group Type EXPERIMENTAL

Fluzone

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluzone

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

Intervention Type BIOLOGICAL

Fluad

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes