Human InfluenzaPhase 4NCT04487041
Tfh Dysfunction in HIV and Aging
A Phase 4 study testing Standard dose influenza vaccination and High dose influenza vaccination in people with Human Influenza, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- Standard dose influenza vaccination and High dose influenza vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
- Cluster of differentiation 4 (CD4) count available in the prior 6 months and >200/mm3
- Undetectable viral load (< 40 copies/mL). Blips of <1000 copies/mL will be allowed.
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- For HIV negative participants:
- Documented negative HIV test at the time of study entry, either by any licensed ELISA.
- For all participants:
- Individuals age: ≤35 years and ≥65 years.
- No history of other immunodeficiency disorders
- Not on steroid or other immunosuppressive/immunomodulators medications.
- No active malignancies.
- Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
- Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
- Able to provide informed consent.
Who cannot join
- Contraindication to receive influenza vaccination.
- Non-adherence to ART for HIV positive
- Unable to provide informed consent.
- Influenza vaccination already given during the current vaccination season.
- Known drug abuse including cocaine by history
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Human Influenza
- Being tested
- Standard dose influenza vaccination, High dose influenza vaccination
- Keywords
- HIV, Aging, flu vaccination, high dose vaccination, immune function
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard dose influenza vaccinationBiological
Also called Fluzone quadrivalent
Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
High dose influenza vaccinationBiological
Also called Fluzone high dose quadrivalent
4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Standard dose influenza vaccination; Biological: High dose influenza vaccination |
| 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. Receives: Biological: Standard dose influenza vaccination; Biological: High dose influenza vaccination |
| 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. Receives: Biological: Standard dose influenza vaccination; Biological: High dose influenza vaccination |
| 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. Receives: Biological: Standard dose influenza vaccination; Biological: High dose influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAI antibody response
Change in mean titers of Hemagglutination inhibition (HAI) antibody response will be measured using serum sample.
Measured: 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.
Measured: 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.
Measured: Month 13 (1 month post high-dose flu vaccination)
Secondary outcomes (4)
Percentage of T-follicular helper (Tfh) cells
Percentage of Tfh cells as measured using peripheral blood samples
Measured: Month 13 (1 month post high-dose flu vaccination)
Percentage of B cells
Percentage of B cells as measured using peripheral blood samples
Measured: Month 13 (1 month post high-dose flu vaccination)
Percentage of monocytes
Percentage of monocytes as measured using peripheral blood samples
Measured: 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
Measured: Month 13 (1 month post high-dose flu vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start30 Oct 2020
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savita Pahwa, University of Miami
- Investigators
- Savita Pahwa, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487041
- Sponsor's protocol ID
- 20200752
- Status last verified
- May 2026
- First submitted
- 22 Jul 2020
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41785036
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tfh Dysfunction in HIV and Aging
- ClinicalTrials.gov ID
- NCT04487041
- Acronym / sponsor ID
- 20200752
- Conditions
- Human Influenza
- Keywords
- HIV, Aging, flu vaccination, high dose vaccination, immune function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young HIV negative group | Active comparator | Biological: Standard dose influenza vaccination, Biological: High dose influenza vaccinationHIV 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. |
| Young HIV positive group | Experimental | Biological: Standard dose influenza vaccination, Biological: High dose influenza vaccinationHIV 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. |
| Old HIV negative group | Experimental | Biological: Standard dose influenza vaccination, Biological: High dose influenza vaccinationHIV 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. |
| Old HIV positive group | Experimental | Biological: Standard dose influenza vaccination, Biological: High dose influenza vaccinationHIV 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- For HIV positive participants:
- For HIV negative participants:
- For all participants:
Key exclusion criteria (5 listed)
- Contraindication to receive influenza vaccination.
- Non-adherence to ART for HIV positive
- Unable to provide informed consent.
- Influenza vaccination already given during the current vaccination season.
- Known drug abuse including cocaine by history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard dose influenza vaccinationAlso: Fluzone quadrivalentSingle 0.5 ml injection administered intramuscularly into participant's deltoid muscle | Biological | Old HIV negative group, Old HIV positive group, Young HIV negative group, Young HIV positive group |
| High dose influenza vaccinationAlso: Fluzone high dose quadrivalent4 times more concentrated single 0.7 ml injection administered intramuscularly into participant's deltoid muscle | Biological | Old HIV negative group, Old HIV positive group, Young HIV negative group, Young HIV positive group |
Primary outcome
Change in HAI antibody response
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.
Change in neutralization antibody response
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.
Percentage of Participants with Vaccine Response
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.
4 secondary outcomes
Percentage of T-follicular helper (Tfh) cells
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of B cells
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of monocytes
Time frame: Month 13 (1 month post high-dose flu vaccination)
Percentage of Tfh cells producing cytokines
Time frame: Month 13 (1 month post high-dose flu vaccination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 41785036Kupritz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savita Pahwa, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard dose influenza vaccination and High dose influenza vaccination in people with Human Influenza, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HAI antibody response (time frame: Baseline to Month 6 (post standard dose flu vaccination), Baseline to Month 18 (post high-dose flu vaccination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.