Propositive Follow-up
Research type
Research Study
Full title
Evaluation of the immunogenicity of Meningococcal B (4CMenB) and Meningococcal ACWY (MenACWY Conjugate) vaccination in a population with HIV at 12 and 24 months after two doses of vaccine
IRAS ID
275845
Contact name
Catherine Cosgrove
Contact email
Sponsor organisation
St Georges Joint Research and Enterprise Service
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Research Summary
Certain groups including babies, teenagers and people with immune system dysfunction are at increased risk of Invasive Meningococcal Disease (IMD). People Living with HIV are particularly at risk. There are now vaccines available (Bexsero and Menveo) which protect against 5 of the main 6 serotypes of Neisseria meningitidis which is the bacteria responsible for IMD. Data on how immunogenic these vaccines are is only available from healthy adults and children as part of the original clinical trials. To date there is no published research showing how immunogenic these vaccines are in People Living With HIV. The Propositive study lead by Dr Catherine Cosgrove at St Georges University of London assessed how immunogenic these vaccines are one month after completion of a two dose course. The results of this study will be available in 2020. As we have a cohort of patients with HIV who have received both Menveo and Bexsero as part of the Propositive study we would now like to follow up this cohort and find out how much protection these participants have at one year and two years post vaccination. This will help to guide recommendations about the timing of booster doses of these vaccines.
Summary of Results
People living with HIV are at increased risk of invasive meningococcal disease. There is little evidence on how well meningococcal vaccines protect this group of patients.
Propositive follow-up is the continuation of the Propositive trial, a vaccine study in people living with HIV which looked at the immune response to two Meningococcal vaccines: 4CMenB and MenACWY.
In the original study, 55 participants received 2 doses of 4CMenB and MenACWY one month apart. They had blood tests one month after vaccination to measure antibody levels against different meningococcus strains. The aim of the follow-up study was to evaluate the long-term immune response to the vaccine in the same group of patients 1.5 and 2.5 years after vaccination,.
The study was sponsored and run by St George’s University of London and funded by GlaxoSmithKline. 40 of the patients who completed the original trial were recruited, they had bloods taken 1.5 and 2.5 years after their original vaccination. Bloods samples were analysed in the UK Meningococcal Reference laboratory for antibodies against meningococcus serogroups A,C,W and Y and three different meningococcal B strains.
Study results showed that antibody levels at 1.5 and 2.5 years had been reduced from the peak 1 month after vaccination but 75%-85% of participants retained protective levels against MenB strains, while 68.8% of patients retained protective antibody titres against all three MenB strains. Antibody levels against Meningococcus serogroup C fell quicker than those against serogroups A, W, and Y. The proportion of participants with protective antibody levels against MenC at 2.5 years was also lower (46.9%) than against MenA (87.5%), W (78.1%), and Y (87.5%).
Overall, the Immune responses against Meningogoccus serogroup B in our cohort of people living with HIV at 2.5 years of follow-up were reassuring, However, responses against MenC were lower than those against MenA, W, and Y. Further studies would be needed inform the need for potential booster doses beyond 3 years after vaccination.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0087
Date of REC Opinion
28 Jul 2020
REC opinion
Further Information Favourable Opinion