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

Not Applicable

Not yet recruiting

• Conditions: Antibody Response
• Interventions: Drug: cell-based; Drug: MF-59; Drug: egg-based

• Registration Number: NCT07126652
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-10-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cell-based	cell-based	-
MF-59	MF-59	-
Egg-based	egg-based	-

Primary Outcome Measures

Name	Time	Method
SCR	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.