Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
400 participants
INTERVENTIONAL
2020-11-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HIV positive opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
HIV positive non-opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
HIV negative opioid users
Participants will receive flu vaccination as part of the study
Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
HIV negative non-opioid users
Participants will receive flu vaccination as part of the study
Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Interventions
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Fluzone Quadrivalent
0.5 ml prefilled syringe administrated intramuscularly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Miami
OTHER
Responsible Party
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Savita Pahwa
Professor
Principal Investigators
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Savita Pahwa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20200178
Identifier Type: -
Identifier Source: org_study_id
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