Opioid, HIV and Immune System

Study Overview
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Brief Summary
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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.

Official Title
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Immune Dysfunction in HIV+ Opioid Users

Conditions
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Immune Defect

Intervention / Treatment
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* Biological: Fluzone Quadrivalent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Opioid (OP) users/non-users: OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days Opioid never-users in the past year Additional criteria for OP users: OP use for 90 days pre-flu vaccination Continued OP use for 4 weeks post flu vaccination For HIV positive participants: 1) HIV infection, as documented by any licensed ELISA kit and confirmed by Western blot at any time prior to study entry. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection. Additional criteria for HIV positive participants: On ART for at least 1 year with plasma pending viral load (VL) <200 copies/mL. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment CD4 count available in the prior 6 months and >200/mm3 Undetectable viral load (< 200 copies/mL) For HIV negative participants: 1) Documented negative HIV test, either by any licensed ELISA or rapid tests within the past 6 months. For all participants: Individuals age 18-60 yrs . No history of other immunodeficiency disorders Not on steroid or other immunosuppressive/immunomodulators medications. No active malignancies. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine). Agreeable to receive the influenza vaccination. Agreeable to participate in study for a complete course of study full visits. Able to provide informed consent. Exclusion Criteria: Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine). Non-adherence to ART for HIV+ Unable to provide informed consent. Other comorbid conditions such as diabetes mellitus type 2 (DMT2) Influenza vaccination already given during the current vaccination season.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV positive opioid users<br>Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study | Biological: Fluzone Quadrivalent<br>* 0.5 ml prefilled syringe administrated intramuscularly<br>* Other names: Influenza vaccination;|
| Experimental: HIV positive non-opioid users<br>Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study | Biological: Fluzone Quadrivalent<br>* 0.5 ml prefilled syringe administrated intramuscularly<br>* Other names: Influenza vaccination;|
| Experimental: HIV negative opioid users<br>Participants will receive flu vaccination as part of the study | Biological: Fluzone Quadrivalent<br>* 0.5 ml prefilled syringe administrated intramuscularly<br>* Other names: Influenza vaccination;|
| Experimental: HIV negative non-opioid users<br>Participants will receive flu vaccination as part of the study | Biological: Fluzone Quadrivalent<br>* 0.5 ml prefilled syringe administrated intramuscularly<br>* Other names: Influenza vaccination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the antibody response | Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels. | Baseline, 4 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune activation levels | Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry. | Baseline | 
| Inflammation biomarker levels | Plasma levels of Interleukin (IL)-6, IL-8, IL-12, IL-17, IL-22, Tumor necrosis factor (TNF) and monocyte activation markers soluble CD14 and soluble CD163 will be assessed via Magpix. All the biomarkers will be measured in nanograms/milliliter. | Baseline | 
| Circulating T follicular helper cell function | T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry. | Week 4 | 
| Circulating T follicular helper cell frequency | T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu vaccine response and HIV