Opioid, HIV and Immune System

Phase 4

Recruiting

• Conditions: Immune Defect
• Interventions: Biological: Fluzone Quadrivalent

• Registration Number: NCT04304768
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-11
• Study Start: 2020-11-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

For Opioid (OP) users/non-users:

1. OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
2. Opioid never-users in the past year

Additional criteria for OP users:

1. OP use for 90 days pre-flu vaccination
2. 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:

1. 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
2. CD4 count available in the prior 6 months and >200/mm3
3. 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:

1. Individuals age 18-60 yrs .
2. No history of other immunodeficiency disorders
3. Not on steroid or other immunosuppressive/immunomodulators medications.
4. No active malignancies.
5. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
6. Agreeable to receive the influenza vaccination.
7. Agreeable to participate in study for a complete course of study full visits.
8. Able to provide informed consent.

Exclusion Criteria

1. Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
2. Non-adherence to ART for HIV+
3. Unable to provide informed consent.
4. Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
5. Influenza vaccination already given during the current vaccination season.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV negative opioid users	Fluzone Quadrivalent	Participants will receive flu vaccination as part of the study
HIV positive opioid users	Fluzone Quadrivalent	Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
HIV positive non-opioid users	Fluzone Quadrivalent	Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
HIV negative non-opioid users	Fluzone Quadrivalent	Participants will receive flu vaccination as part of the study

Primary Outcome Measures

Name	Time	Method
Change in the antibody response	Baseline, 4 weeks, 6 months	Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.

Secondary Outcome Measures

Name	Time	Method
Immune activation levels	Baseline	Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.
Circulating T follicular helper cell function	Week 4	T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.
Circulating T follicular helper cell frequency	Week 4	T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry.
Inflammation biomarker levels	Baseline	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States