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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
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 6 (post standard dose flu vaccination), baseline to month 18 (post high-dose flu vaccination)
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)
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 moreSide effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Left partial cranial nerve III palsy
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Acute pulmonary embolism and acute deep vein thrombosis
1%
Acute Hyperkalemia
1%
Shortness of Breath
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
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.
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Who is running the clinical trial?
University of MiamiLead Sponsor
909 Previous Clinical Trials
410,971 Total Patients Enrolled
Savita Pahwa, MDPrincipal Investigator - University of Miami
University of Miami
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive, on treatment for over a year, with a CD4 count over 200 and an undetectable viral load.You can't get the flu shot, don't take your HIV medication regularly, can't understand what the study is about, already got the flu shot this year, or have a history of drug abuse, including cocaine.
Research Study Groups:
This trial has the following groups:- Group 1: Young HIV negative group
- Group 2: Young HIV positive group
- Group 3: Old HIV positive group
- Group 4: Old HIV negative group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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
Who else is applying?
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
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