Immune DefectPhase 4NCT04304768
Opioid, HIV and Immune System
A Phase 4 study testing Fluzone Quadrivalent in people with Immune Defect, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Defect
- What is being tested?
- Fluzone Quadrivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 23Show fewer
- 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:
- 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:
- 1) 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Dysfunction in HIV+ Opioid Users
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
- Being tested
- Fluzone Quadrivalent
- Keywords
- Flu vaccine response and HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone QuadrivalentBiological
Also called Influenza vaccination
0.5 ml prefilled syringe administrated intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| HIV positive opioid users | Experimental | Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study Receives: 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 Receives: Biological: Fluzone Quadrivalent |
| HIV negative opioid users | Experimental | Participants will receive flu vaccination as part of the study Receives: Biological: Fluzone Quadrivalent |
| HIV negative non-opioid users | Experimental | Participants will receive flu vaccination as part of the study Receives: Biological: Fluzone Quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the antibody response
Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.
Measured: Baseline, 4 weeks, 6 months
Secondary outcomes (4)
Immune activation levels
Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.
Measured: 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.
Measured: Baseline
Circulating T follicular helper cell function
T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.
Measured: Week 4
Circulating T follicular helper cell frequency
T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start18 Nov 2020
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immune DefectStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savita Pahwa, University of Miami
- Investigators
- Savita Pahwa, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304768
- Sponsor's protocol ID
- 20200178
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38793771Dang 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.
PubMed 38022645Dang 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.
PubMed 41479899
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Dysfunction in HIV+ Opioid Users
- ClinicalTrials.gov ID
- NCT04304768
- Acronym / sponsor ID
- 20200178
- Conditions
- Immune Defect
- Keywords
- Flu vaccine response and HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV positive opioid users | Experimental | Biological: Fluzone QuadrivalentParticipants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study |
| HIV positive non-opioid users | Experimental | Biological: Fluzone QuadrivalentParticipants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study |
| HIV negative opioid users | Experimental | Biological: Fluzone QuadrivalentParticipants will receive flu vaccination as part of the study |
| HIV negative non-opioid users | Experimental | Biological: Fluzone QuadrivalentParticipants will receive flu vaccination as part of the study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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
- OP use for 90 days pre-flu vaccination
- Continued OP use for 4 weeks post flu vaccination
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone QuadrivalentAlso: Influenza vaccination0.5 ml prefilled syringe administrated intramuscularly | Biological | HIV negative non-opioid users, HIV negative opioid users, HIV positive non-opioid users, HIV positive opioid users |
Primary outcome
Change in the antibody response
Time frame: Baseline, 4 weeks, 6 months
Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.
4 secondary outcomes
Immune activation levels
Time frame: Baseline
Inflammation biomarker levels
Time frame: Baseline
Circulating T follicular helper cell function
Time frame: Week 4
Circulating T follicular helper cell frequency
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 38793771Ghanta 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.
- Background: PubMed 38022645Dang 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.
- Background: PubMed 41479899Dang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savita Pahwa, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone Quadrivalent in people with Immune Defect, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the antibody response (time frame: Baseline, 4 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.