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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young HIV negative group | Active Comparator | HIV uninfected participants that are 18-35 years of age will receive the standard dose flu vaccine. Participants who did not respond to the standard dose flu vaccination, as defined by less than a four-fold increase in flu antibody titer from baseline, will then receive the high dose flu vaccination 1 year after initial standard dose flu vaccination. Participants who respond to the standard dose flu vaccination will not receive the high dose flu vaccination. |
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| Young HIV positive group | Experimental | HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 18-35 years of age, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose. |
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| Old HIV negative group | Experimental | HIV uninfected participants that are 65 years and older will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose. |
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| Old HIV positive group | Experimental | HIV infected viral suppressed participants, who are on anti-retroviral therapy (ART) aged 65 years and older, will receive the standard dose flu vaccine first followed by the high dose flu vaccine 1 year after initial standard dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose influenza vaccination | Biological | Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HAI antibody response | Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample. | Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination) |
| Change in neutralization antibody response | Change in mean titers of neutralization antibody response will be measured using serum sample. | Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination) |
| Percentage of Participants with Vaccine Response | 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. | Month 13 (1 month post high-dose flu vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of T-follicular helper (Tfh) cells | Percentage of Tfh cells as measured using peripheral blood samples | Month 13 (1 month post high-dose flu vaccination) |
| Percentage of B cells | Percentage of B cells as measured using peripheral blood samples |
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Inclusion Criteria:
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
For HIV negative participants:
For all participants:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Savita Pahwa, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41785036 | Derived | Kupritz J, Davis S, Liu T, Singh P, Diaz-Pachon DA, Rodriguez A, Boyd SD, Pahwa R, Pallikkuth S, Pahwa SG. High-dose influenza vaccine augments serological and cellular immunity of older people with HIV. JCI Insight. 2026 Mar 5;11(8):e199232. doi: 10.1172/jci.insight.199232. eCollection 2026 Apr 22. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
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| High dose influenza vaccination | Biological | 4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle |
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| Month 13 (1 month post high-dose flu vaccination) |
| Percentage of monocytes | Percentage of monocytes as measured using peripheral blood samples | Month 13 (1 month post high-dose flu vaccination) |
| Percentage of Tfh cells producing cytokines | Percentage of Tfh cells producing cytokines as measured using peripheral blood samples | Month 13 (1 month post high-dose flu vaccination) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |