Opioid, HIV and Immune System

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04304768

Collaborator

(none)

300

Enrollment

Location

Arms

54.4

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Defect	Biological: Fluzone Quadrivalent	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Immune Dysfunction in HIV+ Opioid Users

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Immune activation levels [Baseline]
Activation of T and B cells from peripheral blood mononuclear cells assessed 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Savita Pahwa, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Savita Pahwa, Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04304768

Other Study ID Numbers:

20200178

First Posted:

Mar 11, 2020

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Savita Pahwa, Professor, University of Miami

Flu vaccine response and HIV

Study Results

No Results Posted as of Nov 15, 2021