SAGE
Research type
Research Study
Full title
The immunogenicity of Shingrix vaccination in people living with HIV at risk of shingles infection (SAGE)
IRAS ID
1004647
Contact name
Julie Fox
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Research summary
People living with HIV have a higher risk of developing Herpes Zoster infection (otherwise known as Shingles), than other age-matched populations. Being aged over 60 years is a risk factor for the general population, however people living with HIV are not eligible to be vaccinated against Shingles until they are 70 years old. People living with HIV may have less protection from infections and have more associated illnesses or infections than the general population. Studies involving other vaccines have shown that people living with HIV have a less robust response to vaccination than people without HIV.
HZ/Su (SHINGRIX) is the first vaccine of this type developed to protect against shingles and is licensed for use in the USA and the EU, among other regions. The efficacy against and immune responses to Shingles is durable and suggests that the clinical benefit in older adults is sustained for at least 7 years post-vaccination. Data in all age groups and in HIV infected people for the SHINGRIX vaccine is limited. From July 2021, the vaccine has approval for use in immunocompromised people aged 18 and over and this includes individuals with HIV infection.
This trial addresses the question of, does the Shingrix vaccine produce an immune response in people living with HIV, who are either 50 years and over or adults who acquired HIV at birth. Participants who are recruited from three NHS sites will receive an initial dose of the vaccine followed by a second dose 2 months later. Participants will be on the trial for a total of 48 weeks and have blood samples taken at 3 month intervals to check their immune response to the vaccine. Any participant who has suspected Shingles will have a swab for taken for analysis and treated clinically.
This trial is relevant to people living with HIV as the vaccine is not currently within UK treatment guidelines for these people. This trial will inform the guidelines regarding whether it should be included for these two groups.REC name
Wales REC 2
REC reference
23/WA/0283
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion