Evaluating how opioids affect immune responses to the flu vaccine in HIV-infected and non-infected individuals

Immune Dysfunction in HIV+ Opioid Users

This study is testing how opioid use affects the flu vaccine response in people with and without HIV.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University of Miami (other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT04304768 on ClinicalTrials.gov

What this trial studies

This research evaluates blood samples from both HIV-infected and non-HIV-infected individuals who are either opioid users or non-users to understand the impact of opioids on immune responses to the flu vaccine. Participants include those who have been prescribed opioids for at least 90 days or have injected opioids for the same duration, as well as opioid never-users. The study aims to analyze how these factors influence the effectiveness of the flu vaccine, specifically using the Fluzone Quadrivalent vaccine. The findings could provide insights into the interaction between opioid use, HIV status, and vaccine response.

Who should consider this trial

Good fit: Ideal candidates include HIV-positive individuals on antiretroviral therapy with controlled viral loads, as well as opioid users and non-users.

Not a fit: Patients who are not HIV-positive and have not used opioids may not receive direct benefits from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how opioid use affects vaccine efficacy, potentially leading to improved vaccination strategies for vulnerable populations.

How similar studies have performed: While there is ongoing research into the effects of opioids on immune responses, this specific approach focusing on flu vaccine response in the context of HIV is relatively novel.

Eligibility criteria

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.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Savita Pahwa, MD — University of Miami
• Study coordinator: Savita Pahwa, MD

Conditions: Immune Defect, Flu vaccine response and HIV