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Serological Responses to Adjuvanted Versus Non-adjuvanted Influenza Vaccines Among People With HIV: a Randomized Clinical Trial

Serological Responses to Adjuvanted Versus Non-adjuvanted Influenza Vaccines Among People With HIV: a Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07126652
Enrollment
300
Registered
2025-08-17
Start date
2025-10-01
Completion date
2027-12-31
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody Response

Keywords

HIV, influenza, vaccination, MF-59

Brief summary

Until now, the adjuvanted influenza-related studies focused mainly on people at older ages. However, the data on immunocompromised people, who might have suboptimal serological responses when receiving nonadjuvanted vaccines, is scarce. In this study, we aim to compare the immunogenicity and safety to adjuvanted versus nonadjuvanted seasonal influenza vaccines among people with HIV.

Interventions

DRUGMF-59

MF-59 influenza vaccination

DRUGcell-based

cell-based influenza vaccination

DRUGegg-based

egg-based influenza vaccination

Sponsors

National Taiwan University Hospital, Cancer Center
CollaboratorUNKNOWN
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* People with HIV aged \> 50 years * Latest HIV RNA load tested less than 330 IU/mL

Exclusion criteria

* Confirmed serious adverse effect owing to any type of inluenza vaccine * severe coagulopathy * Have recieved influenza vaccine of 2025-2026 season

Design outcomes

Primary

MeasureTime frameDescription
SCRbetween Day 1 and Day 28±7.The primary end point includes SCR measured by the change in HI titer in serum against the vaccine strains between Day 1 and Day 28±7.

Contacts

Primary ContactWang-Da Liu, M.D., M.P.H.
b95401043@ntu.edu.tw+886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026