Immunogenicity of Different Influenza Vaccine Strategies in Older Adults in a Repeated Vaccination Setting
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Geometric mean titers of hemagglutination inhibition antibodies at 1 month after vaccination
Study Overview
Brief Summary
The goal of this clinical trial is to compare immune responses to different influenza vaccine formulations in older adults and to understand how immune aging and repeated annual influenza vaccination affect these responses.
The main questions it aims to answer are:
- Do standard dose, MF59 adjuvanted, and high dose influenza vaccines produce different immune responses in adults aged 65 years or older?
- How does immune aging affect responses to different influenza vaccine formulations?
- How do immune responses change with repeated annual influenza vaccination, and do these changes differ among vaccine formulations?
Researchers will compare older adults who receive a standard dose, MF59 adjuvanted, or high dose influenza vaccine. Younger adults aged 19-49 years who receive a standard dose influenza vaccine will also be included as a reference group to help evaluate age related differences in immune responses.
Participants will:
- Receive an influenza vaccine.
- Provide blood samples before and after vaccination to measure antibody and other immune responses.
- Some participants will provide additional blood or nasal samples for more detailed evaluation of immune responses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Older adult group: aged 65 years or older
- •Younger reference group: aged 19 to 49 years
- •Able to receive influenza vaccination and complete the scheduled follow up
Exclusion Criteria
- •Receipt of an influenza vaccine or any other vaccine within 4 weeks prior to enrollment
- •Immunocompromised status, including ongoing chemotherapy or immunosuppressive therapy, high dose corticosteroid therapy, history of solid organ or hematopoietic stem cell transplantation, active malignancy, HIV infection, or other clinically significant immunocompromising conditions
- •Moderate or severe acute infection
- •History of allergic reaction to an influenza vaccine or any of its components, or any other condition that precludes influenza vaccination
- •Inability, as determined by the investigator, to understand the purpose and procedures of the study and provide voluntary informed consent
Arms & Interventions
older adults- standard dose influenza vaccine
Intervention: Standard dose influenza vaccine (Biological)
older adults- adjuvanted influenza vaccine
Intervention: MF59 adjuvanted influenza vaccine (Biological)
older adults- high dose influenza vaccine
Intervention: High dose influenza vaccine (Biological)
younger adults- standard dose influenza vaccine
Younger adults aged 19-49 years who receive a standard dose influenza vaccine and serve as a reference group for evaluating age related differences in immune responses
Intervention: Standard dose influenza vaccine (Biological)
Outcomes
Primary Outcomes
Geometric mean titers of hemagglutination inhibition antibodies at 1 month after vaccination
Time Frame: 1 month after vaccination, annually for up to 3 years
Geometric mean titers (GMTs) of hemagglutination inhibition antibodies against each influenza vaccine strain will be assessed at 1 month after vaccination.
Geometric mean fold rise in hemagglutination inhibition antibody titers at 1 month after vaccination
Time Frame: Baseline to 1 month after vaccination, annually for up to 3 years
Geometric mean fold rises (GMFRs) in hemagglutination inhibition antibody titers from baseline to 1 month after vaccination will be assessed for each influenza vaccine strain.
Secondary Outcomes
- Seroconversion rate following influenza vaccination(Baseline and 1 month after vaccination, annually for up to 3 years)
- Frequency of influenza specific B cells following vaccination(Baseline, 1 week, and 1 month after vaccination, annually for up to 3 years)
- normalized level of influenza specific secretory IgA in nasal samples(1 month after vaccination in the first season; baseline and 1 month after vaccination annually in year 2 and 3)
- Frequency of influenza specific T cells following vaccination(Baseline, 1 week, and 1 month after vaccination, annually for up to 3 years)
Investigators
Choi, Min Joo
Associated Professor
Korea University Guro Hospital