Immunogenicity and safety of high-dose versus standard-dose quadrivalent inactivated influenza vaccine in patients living with HIV: A randomized control trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230501002

Enrollment

120

Registered

2023-05-01

Start date

2023-08-22

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients living with HIV HIV, immunocompromised, CD4 count

Interventions

Patients living with HIV randomly receive high-dose quadrivalent inactivated influenza vaccine,Patients living with HIV randomly receive standard-dose quadrivalent inactivated influenza vaccine

Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

High-dose quadrivalent inactivated influenza vaccine,Standard-dose quadrivalent inactivated influenza vaccine

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients living with HIV (age > 15 years old) who have been on antiretroviral therapy for 3 months regardless of their CD4 count

Exclusion criteria

Exclusion criteria: Patients living with HIV (age > 15 years old) who receive influenza vaccination within 6 months

Design outcomes

Primary

Measure	Time frame
Immunogenicity 4 weeks Haeagglutination inhibition titer	—

Secondary

Measure	Time frame
Safety 3 and 7 days Adverse reactions both local and systemic	—

Countries

Thailand

Contacts

Public ContactJackrapong Bruminhent

Faculty of Medicine Ramathibodi Hospital, Mahidol University

jackrapong.brm@mahidol.ac.th022011581

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Sep 19, 2026