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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
Be older than 18 years old
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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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.

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

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

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041
8%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
949 Previous Clinical Trials
428,057 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
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