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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people opioid and non opioid users to understand how opioid affect the immune responses (body defenses against infection) to the flu vaccine.

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.

How does the flu vaccine for immune deficiency differ from other treatments?

The flu vaccine for immune deficiency is unique because it is administered intradermally (just under the skin) rather than intramuscularly (into the muscle), which can be more comfortable due to the smaller needle and lower volume injected. This method may increase vaccine acceptance among patients. ^{1 2 3 4 5}

Research Team

Savita Pahwa, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Fluzone® Intradermal Quadrivalent Influenza Vaccine. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the 2015 Southern Hemisphere formulation of a split-virion inactivated quadrivalent vaccine. [2019]