University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT04487041
The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.
This study is active but is not currently recruiting participants.
18 year and older
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
Exclusion criteria
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
Other names: Fluzone quadrivalent
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle
Other names: Fluzone high dose quadrivalent
Time frame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.
Time frame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Change in mean titers of neutralization antibody response will be measured using serum sample.
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of participants that are vaccine responders and non-responders will be reported. Response is evaluated using seroconversion to the flu vaccine using serum sample.
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of Tfh cells as measured using peripheral blood samples
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of B cells as measured using peripheral blood samples
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of monocytes as measured using peripheral blood samples
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of Tfh cells producing cytokines as measured using peripheral blood samples
University of Miami
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT04682444
Acute Respiratory Viral Infections, Human Influenza
View Trial DetailsNCT05155319
Human Influenza, Infections
Brookvale, New South Wales, Australia
View Trial DetailsNCT01342796
Human Influenza, Infections
Antwerp, Belgium
View Trial DetailsNCT02387294
Human Influenza, Infections
View Trial Details