Immunogenicity of MF59-adjuvanted Versus High-dose Influenza Vaccine in People With HIV: a Randomized Clinical Trial

NCT07644546 | Not Yet Recruiting

• 1 other identifier: 202603137MIPA
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

Seasonal influenza causes morbidity in people with impaired immunity, including adults with elder ages and other comorbidities \[1\]. Standard-dose inactivated influenza vaccines (IIV) may induce lower hemagglutination inhibition (HAI) titers and more rapid waning in these groups. High-dose IIV could generate higher and more durable serological responses, including HAI, B-cell activation and antibody magnitude, which was demonstrated in randomized trials \[2,3\]. MF59-adjuvanted IIV further enhances innate immune activation and antigen presentation, potentially broadening and strengthening responses, particularly during antigenic drift seasons \[4\]. These enhanced platforms represent biologically distinct strategies to overcome reduced vaccine responsiveness. Influenza A/H3N2 was reported as the predominant circulating strain in Taiwan. Initial antigenic characterization suggested suboptimal match between some circulating A/H3N2 viruses (the subclade K variant) and the vaccine reference strain, whereas A/H1N1 viruses appeared consistency with the circulating and vaccine-containing strain \[5\]. As of February 2026, approximately 2,300 cases of severe influenza had been confirmed during the 2025-2026 season, representing the largest epidemic in the post-COVID-19 era. In the meanwhile, both MF59-adjuvanted and high-dose influenza vaccine were firstly introduced in Taiwan for elderly people \[5\]. Previous study had demonstrated that people living HIV (PWH) might have lower humoral immune responses compared with people without HIV, even among PWH with relatively higher (defined as ≥ 350 cells/mm3) CD4 counts \[6\]. In spite of the broad use of these novel influenza vaccines in older adults and other population with immunocompromised status such as the recipient of solid organ transplantation \[7\], evidence gap exists in PWH, where vaccine responses vary by CD4 count, viral suppression, immune activation, comorbidities, and prior vaccination history. High-dose influenza vaccination has shown improved serologic outcomes versus standard dose in PWH in randomized trials \[2\], while data of MF59-adjuvanted vaccines used for PWH are lacking. Moreover, comparative serological responses, durability or effectiveness between the two vaccines (MF59 adjuvant vs high-dose) was only conducted among participants with elder age, which showed that the seroconversion rate for H3N2 among those receiving MF59-adjuvanted vaccines did not meet noninferiority criteria compared with those receiving high-dose vaccines \[8\]. Nevertheless, such data on PWH remains unclear. In this study, we aimed to compare toe immunogenicity among PWH undergoing MF59-adjuvanted or high-dose seasonal influenza vaccine.

Conditions

HIV

Keywords

HIV; influenza; vaccine

Outcome Measures

Primary Outcomes (1)

• The vaccine response rate among participants undergoing MF59-adjuvanted and high-dose influenza vaccines at day 28

  The vaccine response rate among participants undergoing MF59-adjuvanted and high-dose influenza vaccines at day 28, defined as the proportion of patients exhibiting seroconversion for at least 1 viral strain (A/H1N1, A/H3N2, or B) contained in the trivalent vaccines at day 28 after vaccination. Seroconversion was defined as a ≥ 4-fold increase of HAI titer from baseline.

  1 month

Study Arms (3)

MF59-adjuvant vaccine

EXPERIMENTAL

MF59-adjuvant vaccine

Biological: IM

high-dose vaccine

ACTIVE COMPARATOR

Biological: IM

egg-based vaccine

ACTIVE COMPARATOR

Biological: IM

Interventions

IM BIOLOGICAL

0.5ml/Vial, IM on Day1

MF59-adjuvant vaccine; egg-based vaccine; high-dose vaccine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PWH aged ≥18 years

You may not qualify if:

• History of confirmed severe adverse effects owing to any type of influenza vaccine, including anaphylaxis and Guillain-Barré syndrome.
• Severe coagulopathy which causes contraindication for vaccination.
• Already vaccinated with any type of 2026-2027 influenza vaccines.
• Having diagnosed with influenza one month before vaccination.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

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

CONTACT

+886-972-652797; b95401043@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share