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

Sponsor
National Taiwan University Hospital
Study ID
NCT07644546
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IM — BIOLOGICAL
    0.5ml/Vial, IM on Day1

Study Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: MF59-adjuvant vaccine
    MF59-adjuvant vaccine
  • Active Comparator: high-dose vaccine
  • Active Comparator: egg-based vaccine

Primary Outcome Measure

The vaccine response rate among participants undergoing MF59-adjuvanted and high-dose influenza vaccines at day 28 [ Time Frame: 1 month ]

Central Contacts

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