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Vaccine

Influenza Vaccination for HIV-Related Immune Response

Phase 4
Recruiting
Led By Savita Pahwa, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For HIV negative participants: Documented negative HIV test at the time of study entry, either by any licensed ELISA. Individuals age: ≤35 years and ≥65 years. No history of other immunodeficiency disorders. Not on steroid or other immunosuppressive/immunomodulators medications. No active malignancies. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons. Able to provide informed consent.
For HIV positive participants: HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection. Additional criteria for HIV positive: on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment, Cluster of differentiation 4 (CD4) count available in the prior 6 months and >200/mm3, Undetectable viral load (< 40 copies/mL). Blips of <1000 copies/mL will be allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 6 (post standard dose flu vaccination), baseline to month 18 (post high-dose flu vaccination)
Awards & highlights

Study Summary

This trial will compare blood samples from HIV+ and HIV- people to see how well their immune systems respond to the flu vaccine.

Who is the study for?
This trial is for people aged ≤35 or ≥65 years, with or without HIV. HIV+ individuals must be on ART for at least a year, have a CD4 count >200/mm3, and an undetectable viral load. Participants should not have other immune disorders, be taking immunosuppressants, have active cancer, drug abuse history or received this season's flu shot.Check my eligibility
What is being tested?
The study aims to understand how aging and HIV affect the body's defense against flu by comparing immune responses to standard-dose (STD-TIV) and high-dose (HD-TIV) influenza vaccinations in both HIV infected and non-infected participants over two flu seasons.See study design
What are the potential side effects?
Potential side effects from the flu vaccines may include soreness at injection site, fever, muscle pains, headache or fatigue. Severe allergic reactions are rare but can occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am HIV positive, on treatment for over a year, with a CD4 count over 200 and an undetectable viral load.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 6 (post standard dose flu vaccination), baseline to month 18 (post high-dose flu vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 6 (post standard dose flu vaccination), baseline to month 18 (post high-dose flu vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HAI antibody response
Change in neutralization antibody response
Percentage of Participants with Vaccine Response
Secondary outcome measures
Percentage of B cells
Percentage of T-follicular helper (Tfh) cells
Percentage of Tfh cells producing cytokines
+1 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Upper respiratory tract infection
14%
Decreased appetite
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Young HIV positive groupExperimental Treatment2 Interventions
HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 18-35 years of age, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Group II: Old HIV positive groupExperimental Treatment2 Interventions
HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 65 years and older, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Group III: Old HIV negative groupExperimental Treatment2 Interventions
HIV uninfected participants that are 65 years and older will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose.
Group IV: Young HIV negative groupActive Control2 Interventions
HIV uninfected participants that are 18-35 years of age will receive the standard dose flu vaccine. Participants who did not respond to the standard dose flu vaccination, as defined by less than a four-fold increase in flu antibody titer from baseline, will then receive the high dose flu vaccination 1 year after initial standard dose flu vaccination. Participants who respond to the standard dose flu vaccination will not receive the high dose flu vaccination.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
408,859 Total Patients Enrolled
Savita Pahwa, MDPrincipal Investigator - University of Miami
University of Miami
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

High dose influenza vaccination (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04487041 — Phase 4
Flu Research Study Groups: Young HIV negative group, Young HIV positive group, Old HIV positive group, Old HIV negative group
Flu Clinical Trial 2023: High dose influenza vaccination Highlights & Side Effects. Trial Name: NCT04487041 — Phase 4
High dose influenza vaccination (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04487041 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability to join the trial?

"The trial is still open for recruitment, with the initial posting date being October 30th 2020 and its most recent edit occurring on October 17th 2022 according to clinicaltrials.gov."

Answered by AI

Are there any past experiments involving the application of high dose influenza vaccinations?

"Currently, 14 studies are being conducted to assess the efficacy of high dose influenza vaccination. Of these trials, one is currently in phase 3. While many of them are happening in Miami, Florida, 15 separate sites across the country have opened up clinical trial opportunities on this matter."

Answered by AI

Has this research ever been conducted before?

"The study of High dose influenza vaccination began in 2016 under the sponsorship of Pharmacyclics LLC. After a successful Phase 1 trial involving 42 people, it was approved for further research in Phase 2. As we speak 14 trials are currently being conducted across 10 cities and 3 countries."

Answered by AI

Has the FDA authorized the use of high-potency influenza vaccinations?

"High dose influenza vaccination is a Phase 4 intervention, with approval from the relevant authorities. Therefore, our team at Power has assigned it a safety score of 3 on their scale."

Answered by AI

What primary goals does this trial hope to accomplish?

"This 13-month trial intends to assess the alteration in antibody response following a high dose flu vaccine. Secondary objectives include quantifying CD4+ T cells, B Cells, and monocytes within peripheral blood samples."

Answered by AI

How many participants are included in this research project?

"Affirmative, clinicaltrials.gov records show that the trial is actively recruiting participants and was first posted on October 30th 2020. As of October 17th 2022, 400 patients will be admitted through 1 medical centre."

Answered by AI
~122 spots leftby Sep 2025