Clinical trial
Tfh Dysfunction in HIV and Aging
Name
20200752
Description
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.
Trial arms
Trial start
2020-10-30
Estimated PCD
2025-09-30
Trial end
2025-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Standard dose influenza vaccination
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
Arms:
Old HIV negative group, Old HIV positive group, Young HIV negative group, Young HIV positive group
Other names:
Fluzone quadrivalent
High dose influenza vaccination
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle
Arms:
Old HIV negative group, Old HIV positive group, Young HIV negative group, Young HIV positive group
Other names:
Fluzone high dose quadrivalent
Size
400
Primary endpoint
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 neutralization antibody response
Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)
Percentage of Participants with Vaccine Response
Month 13 (1 month post high-dose flu vaccination)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}
Updated at
2023-09-25
1 organization
Organization
University of Miami