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Not yet recruiting NCT07126652

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

No phase Interventional Antibody Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MF-59, cell-based, egg-based.
Who it may be relevant to
Registry conditions: Antibody Response. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug MF-59
    MF-59 influenza vaccination
  • Drug cell-based
    cell-based influenza vaccination
  • Drug egg-based
    egg-based influenza vaccination

Primary outcome measures

  • SCR [Time frame: between Day 1 and Day 28±7.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07126652 · 202506103MIPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗