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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive opioid users | Experimental | Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study |
|
| HIV positive non-opioid users | Experimental | Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study |
|
| HIV negative opioid users | Experimental | Participants will receive flu vaccination as part of the study |
|
| HIV negative non-opioid users | Experimental | Participants will receive flu vaccination as part of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone Quadrivalent | Biological | 0.5 ml prefilled syringe administrated intramuscularly |
|
| 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 |
| 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. |
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Inclusion Criteria:
For Opioid (OP) users/non-users:
Additional criteria for OP users:
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:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Savita Pahwa, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38793771 | Background | Ghanta PP, Dang CM, Nelson CM, Feaster DJ, Forrest DW, Tookes H, Pahwa RN, Pallikkuth S, Pahwa SG. Soluble Plasma Proteins of Tumor Necrosis Factor and Immunoglobulin Superfamilies Reveal New Insights into Immune Regulation in People with HIV and Opioid Use Disorder. Vaccines (Basel). 2024 May 9;12(5):520. doi: 10.3390/vaccines12050520. | |
| 38022645 |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| 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 |
| Dang CM, Nelson CM, Feaster DJ, Kizhner A, Forrest DW, Nakamura N, Iyer A, Ghanta PP, Jayaweera DT, Rodriguez AE, Pahwa RN, Tookes HE, Pallikkuth S, Pahwa SG. Opioids exacerbate inflammation in people with well-controlled HIV. Front Immunol. 2023 Nov 1;14:1277491. doi: 10.3389/fimmu.2023.1277491. eCollection 2023. |
| 41479899 | Background | Dang CM, Nelson CM, Pahwa RN, Tookes HE, Feaster DJ, Singh P, Rodriguez AE, Forrest DW, Nakamura N, Ghanta PP, Jayaweera DT, Iyer A, Pallikkuth S, Pahwa SG. Chronic opioid use is associated with higher antibody response to influenza vaccination in people living with HIV. Front Immunol. 2025 Dec 17;16:1686103. doi: 10.3389/fimmu.2025.1686103. eCollection 2025. |