NCT07126652

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Oct 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

August 11, 2025

Last Update Submit

August 11, 2025

Conditions

Antibody Response

Keywords

HIVinfluenzavaccinationMF-59

Outcome Measures

Primary Outcomes (1)

  • SCR

    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.

    between Day 1 and Day 28±7.

Study Arms (3)

MF-59

EXPERIMENTAL
Drug: MF-59

Cell-based

ACTIVE COMPARATOR
Drug: cell-based

Egg-based

ACTIVE COMPARATOR
Drug: egg-based

Interventions

MF-59DRUG

MF-59 influenza vaccination

MF-59
cell-basedDRUG

cell-based influenza vaccination

Cell-based
egg-basedDRUG

egg-based influenza vaccination

Egg-based

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Wang-Da Liu, M.D., M.P.H.

CONTACT

+886-2-23123456b95401043@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share