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Flu Vaccine for Immune Deficiency

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
- Not on steroid or other immunosuppressive/immunomodulators medications.
- Individuals age 18-60 yrs .
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 6 months
Awards & highlights

Study Summary

This trial will test how different opioids affect the body's response to the flu vaccine in HIV patients and non-HIV patients who use opioids.

Who is the study for?
This trial is for adults aged 18-60 who use opioids and those with or without HIV. Opioid users must have been using for at least 90 days and agree to continue during the study. HIV+ individuals need controlled viral loads, be on ART for a year, and have CD4 counts over 200/mm3. Participants can't join if they've had this season's flu shot, can't consent, are allergic to vaccine components, or have certain health conditions like diabetes.Check my eligibility
What is being tested?
The study is looking at how opioid use affects immune responses in both HIV-infected and non-infected people after getting the Fluzone Quadrivalent flu vaccine. It aims to understand the impact of opioids on how well the body defends against infections post-vaccination.See study design
What are the potential side effects?
While not specified here, common side effects of flu vaccines include soreness at injection site, feverish feelings, muscle aches and occasionally mild allergic reactions such as hives or face swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not taking steroids or other drugs that affect my immune system.
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I am between 18 and 60 years old.
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I do not have any active cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 6 months 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 the antibody response
Secondary outcome measures
Circulating T follicular helper cell frequency
Circulating T follicular helper cell function
Immune activation levels
+1 more

Side effects data

From 2020 Phase 3 trial • 2654 Patients • NCT04120194
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NanoFlu
Fluzone Quadrivalent

Trial Design

4Treatment groups
Experimental Treatment
Group I: HIV positive opioid usersExperimental Treatment1 Intervention
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Group II: HIV positive non-opioid usersExperimental Treatment1 Intervention
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Group III: HIV negative opioid usersExperimental Treatment1 Intervention
Participants will receive flu vaccination as part of the study
Group IV: HIV negative non-opioid usersExperimental Treatment1 Intervention
Participants will receive flu vaccination as part of the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluzone Quadrivalent
2019
Completed Phase 3
~2660

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
902 Previous Clinical Trials
409,716 Total Patients Enrolled
Savita Pahwa, MDPrincipal Investigator - University of Miami
University of Miami
1 Previous Clinical Trials
400 Total Patients Enrolled

Media Library

Fluzone Quadrivalent Clinical Trial Eligibility Overview. Trial Name: NCT04304768 — Phase 4
Immune Deficiency Research Study Groups: HIV positive opioid users, HIV positive non-opioid users, HIV negative opioid users, HIV negative non-opioid users
Immune Deficiency Clinical Trial 2023: Fluzone Quadrivalent Highlights & Side Effects. Trial Name: NCT04304768 — Phase 4
Fluzone Quadrivalent 2023 Treatment Timeline for Medical Study. Trial Name: NCT04304768 — Phase 4

Frequently Asked Questions

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

Are there any vacancies to join this clinical trial?

"Affirmative. Clinicaltrials.gov marks this medical study as actively recruiting, with the initial post made on November 18th 2020 and most recent changes to the protocol taking place on October 17th 2022. The research team hopes to enrol 300 participants at a single location."

Answered by AI

Have there been any other research efforts looking into the effects of Fluzone Quadrivalent?

"Presently, there are 14 studies being conducted on Fluzone Quadrivalent. One of these trials is presently in Phase 3. The main research hub for this medication is Stanford, California; however, 15 other sites across the country also have active clinical trials available."

Answered by AI

Is eligibility for this trial restricted to younger adults beneath the age of 85?

"Patients hoping to partake in this research project must fall within the 18-60 age bracket. For minors or adults over 65, there are 2 and 11 respective clinical trials available for them."

Answered by AI

Is this pioneering study the first of its kind?

"Currently, Fluzone Quadrivalent is the subject of 14 ongoing trials across 3 countries and 10 metropolitan areas. This medication's initial trial was conducted in 2016 by Pharmacyclics LLC. with 42 volunteers; since then, 143 experiments have been completed to bring it up to its current Phase 2 drug approval status."

Answered by AI

What criteria must individuals satisfy to be eligible for this research?

"In order to be an eligible candidate for this trial, patients must have immunological impairments and age between 18 and 60. The recruitment of 300 candidates is the goal set by our team."

Answered by AI

What potential hazards exist when using Fluzone Quadrivalent?

"The safety rating of Fluzone Quadrivalent has been calculated as a 3 due to the completion of Phase 4 clinical trials, which implies it is an authorised treatment."

Answered by AI

How many participants has this research project enrolled?

"Affirmative. According to the clinicaltrials.gov website, this research endeavour is actively enlisting participants, first posted on November 18th 2020 and recently updated October 17th 2022. 300 individuals are required at one medical facility for the study's completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Opioid, HIV and Immune System
Savita Pahwa 2020. "Opioid, HIV and Immune System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04304768.
~72 spots leftby May 2025
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