Opioid, HIV and Immune System

NCT04304768 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 20200178
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Defect

Keywords

Flu vaccine response and HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Immune activation levels

  Baseline

• Inflammation biomarker levels

  Baseline

• Circulating T follicular helper cell function

  Week 4

• Circulating T follicular helper cell frequency

  Week 4

Study Arms (4)

HIV positive opioid users

EXPERIMENTAL

Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study

Biological: Fluzone Quadrivalent

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

Biological: Fluzone Quadrivalent

HIV negative opioid users

EXPERIMENTAL

Participants will receive flu vaccination as part of the study

Biological: Fluzone Quadrivalent

HIV negative non-opioid users

EXPERIMENTAL

Participants will receive flu vaccination as part of the study

Biological: Fluzone Quadrivalent

Interventions

Fluzone Quadrivalent BIOLOGICAL

0.5 ml prefilled syringe administrated intramuscularly

Also known as: Influenza vaccination

HIV negative non-opioid users; HIV negative opioid users; HIV positive non-opioid users; HIV positive opioid users

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (3)

• 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.

  PMID: 38793771 BACKGROUND

• 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.

  PMID: 38022645 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.

  PMID: 41479899 BACKGROUND

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Savita Pahwa, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: November 18, 2020
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)