Serological Responses to Adjuvanted Versus Non-adjuvanted... | NCT07126652

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

NCT07126652

Sponsor

National Taiwan University Hospital

Status

Not yet recruiting

Last Update Posted

Aug 17, 2025Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Antibody Response

Interventions

MF-59
cell-based
egg-based

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 11, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2025

Last Update Posted Date

Aug 17, 2025Actual

Name	Class
National Taiwan University Hospital, Cancer Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
MF-59	Experimental	Drug: MF-59
Cell-based	Active Comparator	Drug: cell-based
Egg-based	Active Comparator	Drug: egg-based

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MF-59	Drug	MF-59 influenza vaccination	MF-59
cell-based

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCR	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.	between Day 1 and Day 28±7.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang-Da Liu, M.D., M.P.H.	Contact	+886-2-23123456	267602	b95401043@ntu.edu.tw

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided