Immunogenicity of Twice-annual Influenza Vaccination in Older Adults in Hong Kong
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Influenza, Human
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 70 years and 79 years
- Gender
- Both males and females
Description
Background: Hong Kong is located in subtropical regions with two seasonal peaks of influenza transmission. North Hemisphere seasonal influenza vaccine is usually available for vaccination by general public starting in October every year before the anticipated winter peak starting in December in Hong...
Background: Hong Kong is located in subtropical regions with two seasonal peaks of influenza transmission. North Hemisphere seasonal influenza vaccine is usually available for vaccination by general public starting in October every year before the anticipated winter peak starting in December in Hong Kong, and it presumably also provides protection against the same prevailing strains during summer peak starting around July of the next year. However, influenza vaccines may have poorer efficacy and effectiveness in older adults. The investigators hypothesize that in a subtropical or tropical location with prolonged circulation of influenza viruses, including the emergence of new strains at different times of the year, twice-annual vaccination with the latest available strains could provide the best protection. Aim: To test the immune profiles over time of older adults following twice-annual influenza vaccination against those receiving once-annual influenza vaccination. Design and subjects: A 5-year immunogenicity study with a randomized placebo-controlled design among 400 older adults aged 70-79 years. The investigators will enroll participants from the general community who attend general outpatient clinics for influenza vaccination or medical or preventive care visits. Eligible individuals will be randomly allocated in equal proportions to two intervention groups (I: once-annual standard inactivated influenza vaccine; II: twice-annual standard inactivated influenza vaccine) consisting of ten rounds of vaccination as designated by the intervention group before each winter/summer influenza season and followed throughout the 5 years. Before each summer influenza season those in group II will receive the inactivated influenza vaccine with the southern hemisphere formulation and the other group will receive saline placebo. For each round of vaccination (or placebo), blood samples for immunological tests will be collected before administration and 30 days after administration among all participants, and at 7, 30 and 91 days after administration in a subset of 25% of the participants. Acute illnesses among participants will be monitored by active surveillance during influenza seasons. The vaccine formulations in each round of vaccination will be updated for each season according to WHO recommendations. Main outcome measures: Antibody titres measured by haemagglutination-inhibition assays, which is an established correlate of protection, in addition to other measurements on humoral and cell-mediated immune responses in the two intervention groups over 5 years.
Tracking Information
- NCT #
- NCT02957890
- Collaborators
- Centers for Disease Control and Prevention
- Hospital Authority, Hong Kong
- Investigators
- Principal Investigator: Benjamin COWLING, PhD The University of Hong Kong