Immunogenicity and Safety of High-dose Influenza Vaccine in People Living With HIV/AIDS and Low CD4 Count

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250910008

Enrollment

Registered

2025-09-10

Start date

2025-09-05

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Immunogenicity and safety of high-dose influenza vaccine in people living with HIV who has low CD4 count. Influenza, Vaccination, HIV

Interventions

Subject will receive intramuscular injection of 60 mcg tetravalent influenza vaccine after 10 mL of blood drawn for baseline.,Subject will receive intramuscular injection of 15 mcg tetravalent influen

Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine

High-dose influenza vaccine,Normal-dose influenza vaccine

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years old or older 2. People living with HIV/AIDS with latest CD4 count was less than 200 cells/ microlitres 3. Availible for following up at Maharaj Nakorn chiang Mai Hospital

Exclusion criteria

Exclusion criteria: 1. Presence of contraindications for influenza vaccine e.g. allergy 2. Unavailable for following up 3. During illness or treatment of any opportunistic infections in HIV/AIDS 4. Receiving influenza vaccine within 6 months 5. Receiving live-attenuated vaccine within 4 weeks 6. Receiving non live-attenuated vaccine within 2 weeks 7. Receiving intravenous immunoglobulin within 3 months 8. Currently received high-dose immunosuppressive medications e.g. steroids equivalent to 20 mg of prednisolone for more than 20 days

Design outcomes

Primary

Measure	Time frame
Immunogenicity at 4 weeks 4 weeks after vaccination Seroconversion of antibody level against 4 strains of influenza viruses by hemagglutination-inhibition (HI) assay	—

Secondary

Measure	Time frame
Safety outcomes 10 days after vaccination Patient reported adverse events by using a questionnaire ,Immunogenicity at 6 months 6 months after vaccination Antibody level against 4 strains of influenza viruses by hemagglutination-inhibition (HI) assay,Influenza-like illness Within 1 year after vaccination Self-report of influenza-like symptoms or confirmed influenza	—

Countries

Thailand

Contacts

Public ContactJirinee Netsuwan

Chiang Mai University

jirinee.net@cmu.ac.th053935482

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026