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

NCT ID: NCT07126652

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Antibody Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MF-59

Group Type EXPERIMENTAL

MF-59

Intervention Type DRUG

MF-59 influenza vaccination

Cell-based

Group Type ACTIVE_COMPARATOR

cell-based

Intervention Type DRUG

cell-based influenza vaccination

Egg-based

Group Type ACTIVE_COMPARATOR

egg-based

Intervention Type DRUG

egg-based influenza vaccination

Interventions

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MF-59

MF-59 influenza vaccination

Intervention Type DRUG

cell-based

cell-based influenza vaccination

Intervention Type DRUG

egg-based

egg-based influenza vaccination

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital, Cancer Center

UNKNOWN

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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

Role: CONTACT

+886-2-23123456 ext. 267602

Other Identifiers

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202506103MIPD

Identifier Type: -

Identifier Source: org_study_id

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