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

National Taiwan University

Status: Not yet enrolling

Conditions: Antibody Response

Treatments: Drug: MF-59; Drug: cell-based; Drug: egg-based

Study type: Interventional

Funder types: Other

Identifiers

NCT07126652

202506103MIPD

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

MF-59

Experimental group

Treatment:

Drug: MF-59

Cell-based

Active Comparator group

Treatment:

Drug: cell-based

Egg-based

Active Comparator group

Treatment:

Drug: egg-based