The TRIVIAL study
Research type
Research Study
Full title
Immunological Responses to the Trivalent Adjuvanted Influenza vaccine in people living with HIV over 65 years of age
IRAS ID
270781
Contact name
Marta Boffito
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
This is a single-centre, observational cohort study to investigate immunological responses to the adjuvanted trivalent inactivated influenza vaccine in people living with HIV over 65 years of age as compared to HIV-infected individuals in the same age group.
We will recruit 32 participants 65 years or older with and without HIV infection from Chelsea and Westminster Hospital outpatient clinics. All study participants will receive the adjuvanted flu vaccine as part of their standard of care. Blood samples will be collected before and at selected time points after vaccination to assess antibody levels against flu in both groups. A complete response to flu vaccine is defined as a four-fold increase in antibody levels at 4 weeks after vaccination compared to baseline. The primary outcome measure of the study is to compare the frequency of vaccine responders between the two groups. If we observe impaired immunological responses to the adjuvanted vaccine in PLWHIV we will investigate possible mechanisms leading to poorer vaccine responses. This will be important for the development of better strategies to improve vaccine responses in these clinical risk groups and ultimately may contribute to planning of future annual influenza immunization plans.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0547
Date of REC Opinion
28 Aug 2019
REC opinion
Favourable Opinion