Flu Vaccine for Immune Deficiency

Overseen By Suresh Pallikkuth, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must be taking: Opioids, ART

Must not be taking: Steroids, Immunosuppressives

Disqualifiers: Diabetes, Immunodeficiency, Malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how opioid use affects the body's response to the flu vaccine, particularly in individuals with HIV. Participants will receive the Fluzone Quadrivalent flu vaccine and will be grouped based on their HIV status and opioid use. The trial suits those who have used opioids for at least 90 days or have not used them in the past year, and either have HIV and are undergoing treatment or have tested negative for HIV. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using opioids, you must continue using them for 4 weeks after the flu vaccination. Participants cannot be on steroids or other immune-affecting medications.

What is the safety track record for these treatments?

Research shows that the Fluzone Quadrivalent flu vaccine is generally safe. Past studies found that most side effects were mild, such as soreness at the injection site, occasional fever, or muscle aches. These reactions are common with most vaccines and typically resolve on their own.

Opioids often manage pain but carry risks, especially with prolonged or improper use. Side effects can include drowsiness, nausea, and constipation. Following the doctor's instructions carefully when using opioids is crucial.

Most people tolerate the flu vaccine well, and understanding how opioids might affect the immune system is a primary goal of the study. Always consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the flu vaccine trial for individuals with immune deficiencies because it explores how well the Fluzone Quadrivalent vaccine works in different groups, particularly those with HIV and/or opioid use. Unlike standard flu vaccines, this trial specifically examines the vaccine's effectiveness in people who are often overlooked in vaccine studies, like those with compromised immune systems or who use opioids. By including these diverse groups, the trial aims to uncover whether the vaccine provides adequate protection and if there are any unique responses or benefits. This could lead to better-targeted flu prevention strategies for vulnerable populations.

What evidence suggests that this trial's treatments could be effective for immune responses to the flu vaccine?

Studies have shown that the Fluzone Quadrivalent flu vaccine works well for people with HIV. A large study involving over 30,000 HIV patients found that the vaccine did not harm their health, including important immune system markers like CD4 counts. This indicates that the vaccine did not worsen their condition and helped protect them from the flu. In this trial, participants will receive the Fluzone Quadrivalent vaccine, with separate groups for HIV-positive and HIV-negative individuals, as well as opioid users and non-users. The vaccine is also safe and effective for other groups, including children. Flu vaccines like Fluzone help the body build immunity, reducing the likelihood of getting sick from the flu. Overall, Fluzone Quadrivalent is a good choice for anyone wanting to protect themselves from the flu, including those with immune system challenges. ^{6 7 8 9 10}

Who Is on the Research Team?

Savita Pahwa, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Additional criteria for HIV positive participants:

I'm sorry, but the criterion you provided is incomplete. Could you please provide more information or context?

For HIV negative participants:

Exclusion Criteria

I have type 2 diabetes.

I am allergic to chicken eggs or something in the flu vaccine.

I have not consistently taken my HIV medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive flu vaccination and continue standard of care antiretroviral therapy (ART) if applicable

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for immune response and antibody levels

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fluzone Quadrivalent
• Opioid

Trial Overview

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.

How Is the Trial Designed?

Group I: HIV positive opioid users Experimental Treatment 1 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 users Experimental Treatment 1 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 users Experimental Treatment 1 Intervention

Participants will receive flu vaccination as part of the study

Group IV: HIV negative non-opioid users Experimental Treatment 1 Intervention

Participants will receive flu vaccination as part of the study

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The study involving 661 children aged 6 months to under 18 years demonstrated that the high-dose quadrivalent influenza vaccine (IIV4-HD) is safe, with no serious adverse events reported and similar rates of mild reactions compared to the standard-dose vaccine.

IIV4-HD at a dose of 60 µg significantly improved immune responses, particularly in younger children (6 months to <3 years), showing higher antibody titers against various influenza strains compared to the standard-dose vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through Chang, LJ., Anderson, EJ., Jeanfreau, R., et al.[2021]

The intradermal (ID) influenza vaccine demonstrated immune responses comparable to the intramuscular (IM) vaccine in a study of 4292 adults, meeting non-inferiority criteria for antibody levels against all three virus strains tested (H1N1, H3N2, and B).

While local injection site reactions were more frequent with the ID vaccine, they were mostly mild and transient, indicating that the ID vaccine is a well-tolerated alternative to the IM vaccine despite slightly higher rates of local discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Gorse, GJ., Falsey, AR., Fling, JA., et al.[2018]

The Southern Hemisphere 2015 formulation of the inactivated split-virion quadrivalent influenza vaccine (IIV4) demonstrated strong immunogenicity, with at least a 10-fold increase in antibody levels for younger adults and a 9-fold increase for older adults after vaccination.

The vaccine was well tolerated with no serious adverse events reported, confirming its safety and effectiveness in generating protective immune responses in both age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the 2015 Southern Hemisphere formulation of a split-virion inactivated quadrivalent vaccine. Montalban, C., Montellano, MB., Santos, J., et al.[2019]

The intradermal quadrivalent influenza vaccine (IIV4-ID) demonstrated non-inferior antibody responses compared to the licensed trivalent vaccine (IIV3-ID) for matched strains and superior responses for unmatched B strains, indicating its potential effectiveness in addressing mismatched strains.

IIV4-ID was well tolerated, with adverse events similar to those of IIV3-ID, primarily mild reactions that resolved quickly, suggesting it is a safe option for vaccination in adults aged 18-64.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Gorse, GJ., Falsey, AR., Ozol-Godfrey, A., et al.[2016]

Fluzone Intradermal Quadrivalent vaccine, introduced for the 2015-2016 season, includes two B-strain lineage viruses, enhancing its effectiveness against influenza by providing broader protection.

The vaccine utilizes a unique microinjection system, which not only improves the delivery method but also aims to alleviate logistical challenges for healthcare providers during vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluzone® Intradermal Quadrivalent Influenza Vaccine. Robertson, CA., Tsang, P., Landolfi, VA., et al.[2018]

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