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

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.

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Key information

Conditions

Antibody Response Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MF-59

Drug

MF-59 influenza vaccination

cell-based

Drug

cell-based influenza vaccination

egg-based

Drug

egg-based influenza vaccination

Primary outcomes

SCR

Time frame: between 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+886-2-23123456 ext. 267602

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

National Taiwan University Hospital, Cancer Center

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Aug 17, 2025
Registry last updated: Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed