ProPositive
Research type
Research Study
Full title
Evaluation of safety and immunogenicity of meningococcal B and meningococcal ACWY vaccine in at risk population (ProPositive Study)
IRAS ID
244868
Contact name
Angela Bartolf
Contact email
Sponsor organisation
St Georges University of London
Eudract number
2018-002196-17
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Invasive meningococcal disease (IMD) is caused by Neisseria meningitidis when it enters the blood stream (sepsis) and/or crosses the blood-brain barrier (meningitis). Certain populations are at a higher risk of developing serious disease including people living with HIV according to recent UK data. The meningococcal quadrivalent conjugate vaccine (MenACWY, Menveo®) and the recently licenced multicomponent MenB vaccine (4CMenB, Bexsero®) have already been included in the UK childhood immunisation programme. Current recommendations also include these vaccines for those with asplenia and complement deficiency. HIV infection has not been classified as a risk factor for IMD and until recently, it has not been given as an indication for meningococcal vaccination. The British HIV Association (BHIVA) has recently published new guidelines concerning meningococcal vaccination in this population and certain HIV positive patients are now recommended to have two doses of meningococcal vaccines given two months apart.
Recent surveillance undertaken by PHE between 2011 and 2013 has revealed that HIV infection is a risk factor for invasive meningococcal disease in the UK when compared with the HIV uninfected population.
Taken together, these findings strongly suggest that adults living with HIV may benefit from both the MenACWY (Menveo®) conjugate vaccine and the multicomponent 4CMenB (Bexsero®) vaccine. Studies from the US and Brazil have demonstrated the safety and immunogenicity of the quadrivalent vaccine although no studies have not been conducted in the UK (8,9). Safety and immunogenicity of the recently licenced 4CMenB (Bexsero®) vaccine has not been assessed in this population to date.
If the vaccines are found to work well in people with HIV, it may be beneficial to offer these vaccines to all adults with HIV in the future to prevent meningitis infections.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1293
Date of REC Opinion
18 Oct 2018
REC opinion
Further Information Favourable Opinion