Human Influenza
Conditions
Keywords
HIV, Aging, flu vaccination, high dose vaccination, immune function
Brief summary
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.
Interventions
BIOLOGICALStandard dose influenza vaccination
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
BIOLOGICALHigh dose influenza vaccination
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. For HIV positive participants: * HIV infection, as documented by any licensed ELISA test kit. 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 1. on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment, 2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3 3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed. 2. For HIV negative participants: * Documented negative HIV test at the time of study entry, either by any licensed ELISA. 3. For all participants: 1. Individuals age: ≤35 years and ≥65 years. 2. No history of other immunodeficiency disorders 3. Not on steroid or other immunosuppressive/immunomodulators medications. 4. No active malignancies. 5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination. 6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons. 7. Able to provide informed consent.
Exclusion criteria
1. Contraindication to receive influenza vaccination. 2. Non-adherence to ART for HIV positive 3. Unable to provide informed consent. 4. Influenza vaccination already given during the current vaccination season. 5. Known drug abuse including cocaine by history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HAI antibody response | 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. |
| Change in neutralization antibody response | 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. |
| Percentage of Participants with Vaccine Response | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of T-follicular helper (Tfh) cells | Month 13 (1 month post high-dose flu vaccination) | Percentage of Tfh cells as measured using peripheral blood samples |
| Percentage of B cells | Month 13 (1 month post high-dose flu vaccination) | Percentage of B cells as measured using peripheral blood samples |
| Percentage of monocytes | Month 13 (1 month post high-dose flu vaccination) | Percentage of monocytes as measured using peripheral blood samples |
| Percentage of Tfh cells producing cytokines | Month 13 (1 month post high-dose flu vaccination) | Percentage of Tfh cells producing cytokines as measured using peripheral blood samples |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSavita Pahwa, MD
University of Miami
Outcome results
None listed