Respiratory syncytial virus (RSV)

Respiratory syncytial virus (RSV) is a common cause of upper and lower respiratory tract infections in children and adults. It is the most common cause of bronchiolitis in infants under a year of age and results in up to 500,000 GP attendances, 30,000 hospitalisations and 900 paediatric intensive care unit admissions per year in children under 5 years of age in the UK. It also causes significant morbidity and mortality on older adults. There is currently no widely available antiviral treatment or vaccine. The monoclonal antibody (mAb) palivizumab is available as prophylaxis but due to its high cost is only given to the highest risk infants; those born extremely prematurely or with significant congenital heart disease. However, many novel antiviral treatments, vaccines and mAbs are in development.

At the PIDRG and SGVI, we have a special interest in studying RSV infection. Below are key studies we have previously undertaken or have ongoing:

  1. Respiratory syncytial virus consortium in Europe (RESCEU) infant case-control study
    This European Union Innovative Medicines Initiative (EU IMI) funded observational study carried out within the RESCEU consortium investigated risk factors and biomarkers for the development of severe RSV infection in infants across Europe.
  1. Novavax maternal RSV vaccine
    SGVI recruited pregnant women to this phase 3 trial of an RSV vaccine in pregnant women. It was one of the first studies to show proof of concept in terms of vaccinating pregnant women to protect the infant against (severe) RSV infection.
  1. IBERIS study
    This was an observational and interventional study sponsored by Janssen investigating the use of a mobile phone app to identify infants with clinical signs and symptoms of RSV infection and a novel antiviral medication to treat those infants with proven infection.

Ongoing

  1. MELODY and MEDLEY
    These AstraZeneca sponsored studies are investigating a long acting (one dose per RSV season) mAb to prevent RSV infection in preterm and term born infants.
  1. ASSERVO study
    The SGVI is the lead UK site for this study sponsored by MSD. It is investigating the use of another long acting mAb to prevent RSV infection in young infants. Recruitment will begin in September 2021.

Project Team

Consultant in Paediatric Infectious Diseases

Simon Drysdale

Senior Clinical Research Fellow

Eva Galiza

Paediatric Clinical Research Fellow

Hazel Fofie

Paediatric Research Nurse

Fran Mabesa

Project Officer

Shivani Patel

Consultant in Paediatric Infectious Diseases

Simon Drysdale

Simon Drysdale is a consultant and honorary senior lecturer in paediatric infectious diseases and immunology at St George’s University Hospitals NHS Foundation Trust. He is the paediatric antimicrobial stewardship lead at St George’s and principal investigator on several clinical trials investigating diagnostics, novel treatments and prophylactics for RSV and SARS-CoV-2. His research interests are host susceptibility to RSV and other respiratory viral infections and antimicrobial resistance and stewardship.
  1. Drysdale SB, Kelly DF, Morgan M, Peto T, Crook D, Matthews PC, Walker TM. Case Report: Disseminated, rifampicin resistant Mycobacterium bovis (BCG) infection in an immunocompromised child. Wellcome Open Research 2020; 5: 242.
  2. Lin GL, Golubchik T, Drysdale S, O’Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinón-Torres F, Bowden R, Pollard AJ. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Jul 23:jiaa448. doi: 10.1093/infdis/jiaa448. Online ahead of print.
  3. Jefferies K, Drysdale SB, Robinson H, Clutterbuck EA, Blackwell L, McGinley J, Lin GL, Galal U, Nair H, Aerssens J, Öner D, Langedijk A, Bont L, Wildenbeest JG, Martinon-Torres F, Rodríguez-Tenreiro Sánchez C, Nadel S, Openshaw P, Thwaites R, Widjojoatmodjo M, Zhang L, Nguyen TL, Giaquinto C, Giordano G, Baraldi E, Pollard AJ; Respiratory Syncytial Virus Consortium in Europe (RESCEU) Investigators. Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU). J Infect Dis. 2020 Aug 14:jiaa239. doi: 10.1093/infdis/jiaa239. Online ahead of print.
  4. Öner D, Drysdale SB, McPherson C, Lin GL, Janet S, Broad J, Pollard AJ, Aerssens J; RESCEU Investigators. Biomarkers for Disease Severity in Children Infected With Respiratory Syncytial Virus: A Systematic Literature Review. J Infect Dis. 2020 Aug 14:jiaa208. doi: 10.1093/infdis/jiaa208. Online ahead of print.
  5. Sande CJ, Njunge JM, Mwongeli Ngoi J, Mutunga MN, Chege T, Gicheru ET, Gardiner EM, Gwela A, Green CA, Drysdale SB, Berkley JA, Nokes J, Pollard AJ. Airway response to respiratory syncytial virus has incidental antibacterial effects. Nat Commun. 2019;10(1):2218. doi: 10.1038/s41467-019-10222-z.

Senior Clinical Research Fellow

Eva Galiza

Dr Eva Galiza joined the St. George’s Vaccine Institute (SGVI) in 2006 and has taken part in a wide range of paediatric and adult research work including observational, interventional phase 1-4, CTIMP and non-CTIMPS, and both commercial and non-commercial studies. As the Senior Clinical Research Fellow, Dr Galiza leads and co-ordinates vaccine trials and other infectious diseases studies run by SGVI and the Paediatric Infectious Diseases Research Group (PIDRG), part of the Institute for Infection and Immunity at St. George’s, University of London. She is Principal Investigator for several infectious diseases studies including RSV and coronavirus (COVID-19) vaccine research trials. Currently, Dr Galiza is the lead fellow and coordinator for the Preg-CoV trial looking at COVID-19 vaccines in pregnancy.

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. Online ahead of print. PMID: 34192426

Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial.

Emary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, Blane B, Bonsall D, Cicconi P, Charlton S, Clutterbuck EA, Collins AM, Cox T, Darton TC, Dold C, Douglas AD, Duncan CJA, Ewer KJ, Flaxman AL, Faust SN, Ferreira DM, Feng S, Finn A, Folegatti PM, Fuskova M, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hallis B, Heath PT, Hay J, Hill HC, Jenkin D, Kerridge S, Lazarus R, Libri V, Lillie PJ, Ludden C, Marchevsky NG, Minassian AM, McGregor AC, Mujadidi YF, Phillips DJ, Plested E, Pollock KM, Robinson H, Smith A, Song R, Snape MD, Sutherland RK, Thomson EC, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Williams CJ, Hill AVS, Lambe T, Gilbert SC, Voysey M, Ramasamy MN, Pollard AJ; COVID-19 Genomics UK consortium; AMPHEUS Project; Oxford COVID-19 Vaccine Trial Group.

Lancet. 2021 Apr 10;397(10282):1351-1362. doi: 10.1016/S0140-6736(21)00628-0. Epub 2021 Mar 30. PMID: 33798499

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.

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.

Lancet. 2021 Mar 6;397(10277):881-891. doi: 10.1016/S0140-6736(21)00432-3. Epub 2021 Feb 19. PMID: 33617777

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.

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.

Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. PMID: 33306989

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

Paediatric Clinical Research Fellow

Hazel Fofie

Dr Hazel Fofie is a clinical research fellow and paediatric registrar based in London with interests in international child health, acute paediatrics, paediatric infectious diseases and health inequalities. She trained at St George’s, University of London and completed an intercalated BSc in Global Health at Kings College London. She has attained membership with the Royal College of Paediatrics and Child Health and has obtained the professional diploma in tropical medicine and hygiene.

 

She takes part in ongoing paediatric research activity run by St George’s Vaccine George’s Vaccine Institute and the Paediatric Infectious Diseases Research Group (PIDRG), an in particular the day to day organisation and running of the RSV Vaccine Studies and some COVID-19 vaccine trials.

Her most recent publication is a commentary in EClinical Medicine Series published by The Lancet, Ethnic minority and migrant underrepresentation in Covid-19 research: Causes and solutions.

 

Etti M, Fofie H, Razai M, Crawshaw A, Hargreaves S, Goldsmith L. Ethnic minority and migrant underrepresentation in Covid-19 research: Causes and solutions. EClinical Medicine. 2021 [Available from: http://www.sciencedirect.com/science/article/pii/S2589537021001838

Paediatric Research Nurse

Fran Mabesa

National Health Training College; Diploma in General Nursing Diploma in Midwifery.

Middlesex University; BSc in Occupational Safety, Health and Environment.

Project Officer

Shivani Patel

I am a graduate of the University of Brighton, where I completed my Bsc in Pharmaceutical Chemistry. I have 5 years of experience working within healthcare, and a year within clinical trials specifically. I joined the PIDRG team in November 2020 during the COVID-19 pandemic. Since joining I have been involved in the set up and day to day running of the Oxford COVID-19 vaccine trials for both adults and paediatrics. I am also currently involved with multiple RSV studies and also the paediatric observational study DIAMONDS.