Neisseria meningitidis (meningococcus) is a bacterium which causes meningitis and septicaemia. There are 13 serogroups of meningococcus, 6 (A, B, C, W, X and Y) cause most disease of which MenB is the most common cause of meningococcal disease in the UK. Infants have the highest incidence of MenB disease in the UK and across Europe, with the main burden of disease falling in the second 6 months of life.
In 2015 the UK became the first country in the world to introduce Men B vaccination with 4CMenB (Bexsero®) into its routine schedule, with a two-dose priming regime at 2 and 4 months with a booster at 12 months. The vaccine has proved to be very effective in preventing invasive MenB disease in immunised infants (Parikh et al, 2016). This study also showed that a single dose of 4CMenB however, was not effective. Half the MenB cases diagnosed after 16 weeks of age in the vaccine-eligible infant cohort were either unvaccinated or partially vaccinated (i.e. received only a single dose of 4CMenB). Such cases could potentially have been prevented through timely or, preferably, earlier completion of the primary immunisation schedule.
Current studies:
LION MenB study
This study is being undertaken to compare the immune responses of UK infants who receive their routine immunisations alongside two different 4CMenB primary immunisation schedules. Completing the primary 4CMenB schedule by 3 months could provide infants earlier protection against MenB disease since cases peak at 5 months of age and remain high in the second half of the first year before starting to decline.
If this clinical trial shows comparable immunogenicity for the main 4CMenB antigens using the two different schedules, then the results could change UK national immunisation policy to offer infants earlier protection against this devastating disease and could potentially be adopted by other countries worldwide.
Project Team
Paediatric Clinical Research Fellow
Natalina Sutton
Paediatric Clinical Research Fellow
Zsofia Danos
Director
Paul Heath
Project Manager
Polly Fox
Paediatric Clinical Research Fellow
Natalina Sutton
Natalina is currently a Clinical Research Fellow at St George’s Paediatric Infectious Diseases Research Group, working on COVID-19 and MenACWY vaccine studies. She has over a decades experience in child health in global settings. She has applied 6 years of experience as a foundation doctor and paediatric trainee to global public health work including, participation in mobile clinics to ensure access to healthcare for remote populations in Belize, and development of health promotion projects in Ecuador and Mexico. Natalina has a MSc in Public Health from the London School of Hygiene and Tropical Medicine and has carried out research projects on predicting IVIG resistance in Kawasaki Disease and prevention of childhood obesity in preschool children.
Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S; 2019nCoV-302 Study Group. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. N Engl J Med. 2021 Jun 30
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O’Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.
Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Clutterbuck EA, Collins AM, Cutland CL, Darton TC, Dheda K, Dold C, Duncan CJA, Emary KRW, Ewer KJ, Flaxman A, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hill C, Hill HC, Hirsch I, Izu A, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Libri V, Lillie PJ, Marchevsky NG, Marshall RP, Mendes AVA, Milan EP, Minassian AM, McGregor A, Mujadidi YF, Nana A, Padayachee SD, Phillips DJ, Pittella A, Plested E, Pollock KM, Ramasamy MN, Ritchie AJ, Robinson H, Schwarzbold AV, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, White T, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet. 2021 Mar 6;397(10277):881-891.
Davies S, Sutton N, Blackstock S, Gormley S, Hoggart CJ, Levin M, Herberg JA. Predicting IVIG resistance in UK Kawasaki disease. Arch Dis Child. 2015 Apr;100(4):366-8.
Email:nsutton@sgul.ac.uk
Paediatric Clinical Research Fellow
Zsofia Danos
Zsofia has been working in clinical paediatrics since 2014 and finished Paediatric training in November 2020. Zsofia started working for the paediatric infectious disease research group in September 2020. Her role as a clinical research fellow (currently mainly involved in the COVID-19 vaccine trials) includes recruitment and consenting of participants, reviewing medical history, vaccinating, conducting symptomatic reviews and covering on-call duties. Zsofia also works on the cChips CMV study and looking forward to be involved in other paediatric trials as well.
A Folyovich, I Vastagh, A Kéri, A Majoros, KL Kovács, A Ajtay, Zs Laki, B Gunda, K Erdei, L Lenti, Zs Dános, D Bereczki Living standard is related to microregional differences in stroke characteristics in Central Europe: the Budapest Districts 8-12 Project Int J Public Health DOI 10.1007/s00038-015-0674-y 2015
D. Bereczki, A. Ajtay, A. Majoros, Z. Dános, L. Lenti, K. Erdei, L.K. Kovács, B. Gunda, Z. Laki, A. Kéri, I, Vastagh, A. Folyovich Gender difference in the living standard on 3-year stroke fatality: the Budapest District 8-12 project.
Email:zdanos@sgul.ac.uk
Director
Paul Heath
Paul Heath is a Professor and Honorary Consultant in Paediatric Infectious Diseases at St George’s University Hospitals NHS Foundation Trust and St George’s, University of London, where he co-leads the Paediatric Infectious Diseases Research Group and is the Director of the Vaccine Institute. His particular research interests are in the epidemiology of vaccine preventable diseases, in clinical vaccine trials, particularly in at-risk groups and in perinatal infections. He coordinates a European neonatal infection surveillance network (neonIN) and the UK Paediatric Vaccine Group (UKPVG), and other recent work includes national surveillance on neonatal meningitis, neonatal GBS and Listeria infections, maternal immunisation trials, studies of different vaccine schedules in preterm infants and COVID-19 vaccine trials (Phase I-III). He is Chair of the Research Committee of the European Society of Paediatric Infectious Diseases, Section Editor of the Pediatric Infectious Diseases Journal (maternal & neonatal), Clinical Lead for Children’s research for South London and a member of the WHO GBS Surveillance Technical Working Group.
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, Toback S; 2019nCoV-302 Study Group. N Engl J Med. 2021 Jun 30:NEJMoa2107659. doi: 10.1056/NEJMoa2107659. Vergnano S, Godbole G, Simbo A, Smith-Palmer A, Cormican M, Anthony M, Heath PT. Arch Dis Child. 2021 May 13:archdischild-2021-321602. doi: 10.1136/archdischild-2021-321602. Ding Y, Wang Y, Hsia Y, Russell N, Heath PT. Emerg Infect Dis. 2020 Nov;26(11):2651-2659. doi: 10.3201/eid2611.181414. Khalil A, Kalafat E, Benlioglu C, O’Brien P, Morris E, Draycott T, Thangaratinam S, Le Doare K, Heath P, Ladhani S, von Dadelszen P, Magee LA. EClinicalMedicine. 2020 Aug;25:100446. doi: 10.1016/j.eclinm.2020.100446. Epub 2020 Jul 3.PMID: 32838230 Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Lancet. 2020 Aug 15;396(10249):467-478. doi: 10.1016/S0140-6736(20)31604-4. Epub 2020 Jul 20.PMID: 32702298
Email:pheath@sgul.ac.uk
Secretary Phone:020 8725 3262
Project Manager
Polly Fox
I joined the PIDRG Team in September 2019 as a Project Officer working on a range of studies in RSV, fungal infections, AMR and vaccines. I’m now one of the Project Managers helping to deliver the COVID-19 Vaccine Trials we are running at St George’s as well as other Urgent Public Health studies such as a serological survey in children and young adults. I have also recently started an MSc Clinical Trials with LSHTM part-time to further my career development in trial coordination.
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Email:pfox@sgul.ac.uk