University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT04304768
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.
This study is active but is not currently recruiting participants.
18 year–60 year
All sexes
Interventional
Phase 4
Miami, Florida, 33136, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Opioid (OP) users/non-users:
Additional criteria for OP users:
For HIV positive participants:
Additional criteria for HIV positive participants:
For HIV negative participants:
For all participants:
Exclusion criteria
0.5 ml prefilled syringe administrated intramuscularly
Other names: Influenza vaccination
Time frame: Baseline, 4 weeks, 6 months
Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.
Time frame: Baseline
Activation of T and B cells from peripheral blood mononuclear cells assessed via flow cytometry.
Time frame: 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.
Time frame: Week 4
T follicular helper cell function measured from peripheral blood mononuclear cells via flow cytometry.
Time frame: Week 4
T follicular helper cell frequency measured from peripheral blood mononuclear cells via flow cytometry.
University of Miami
Other
Immune Dysfunction in HIV+ Opioid Users
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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