Dr Helen Hill

Helen is a Senior Clinical Research Associate Respiratory Research, Department of Clinical Sciences at Liverpool School of Tropical Medicine.

Helen has 15 years research experience including regulatory Clinical Trials of Investigational Medicinal Products (CTIMP) in both paediatrics and adults, also, a trial Genetic Modification of Organisms (GMO) regulated by Department for Environment Food and Rural Affairs (DEFRA).

Helen’s recent portfolio of studies includes:

  • Experimental Human Pneumococcal Challenge (EHPC) Model (inoculation of healthy volunteers and bronchoscopy),
  • COVID -19 Oxford Vaccine Trials (as Co-Principal Investigator)
  • COVID – SAFER Study monitoring antibodies in health workers.  
  • GMO attenuated pneumococcal strains (Co-Investigator)
  • Respiratory Syncytial Virus Surveillance (Co-Principal Investigator)
  • Pharmacokinetics and pharmacodynamics of neonatal and infants administered the antibiotic ciprofloxacin for sepsis in critical care.

This portfolio of challenging studies were successfully completed on time and to target. The EHPC team safely challenged over 1800 participants with live bacteria in over 30 clinical studies at the Accelerator Research Clinic. The other studies involved extensive collaboration with NHS Hospitals Nd Primary Care.

As Chief of Operations and Co-Principal Investigator for the Oxford Astra Zeneca Vaccine trial during the covid-19 pandemic at LSTM we achieved the highest recruitment nationally. We set up the trial as a site within 3 weeks, recruited 600 participants within a month and continued to lead two further trials of mixed vaccine schedules. Despite the challenges of these urgent public health prioritisation studies an inspection by the MHRA inspection they reported no critical or major findings at LSTM.  

Helen has actively contributed to the MHRA Risk Adaptive Approach as a member of the steering group to promote a more proportionate approach to the Regulatory Framework.  This included publishing a model for Risk Adaptation in a pharmacokinetic clinical trial of neonates and infants then further blogs on the MHRA web site. Helen jointly presented this with the MHRA Inspectorate to the FDA and EMA. As requested by the Institute of Clinical Research Helen authored a chapter on paediatric consent for the Handbook of Clinical and Healthcare Research.    

Helen obtained a PhD in Pharmacokinetics of Ciprofloxacin in Neonates and Infants with suspected Gram-Negative Sepsis with University of Liverpool Faculty of Medicine. This included conducting a pharmacokinetic clinical trial of sixty neonates and infants in critical care; a pharmacodynamic study comparing the outcome of neonates with confirmed Gram-negative sepsis compared to the Minimum Inhibitory Concentration (MIC) of Ciprofloxacin. The thesis included a study comparison of buccal with serum samples for DNA extraction. 

Selected News and Media

Recognition by the NIHR Clinical Research Network – Research Response to the Pandemic 27th May 2021

‘Helen has been the driving force behind these studies leading multi-disciplinary team from across Merseyside to success and forging networks across Merseyside’.

BBC Radio Merseyside 14th April 2021  COVID-19 vaccine trial, COM COV II.

Granada Reports 8th March 2021 The Liverpool scientists at the forefront of the fight against Covid

Granada Reports 14th April 2021 Covid: 'Mix and match' vaccine trial at Liverpool School of Tropical Medicine expanded to include Moderna and Novavax

Granada Reports  11th February 2021 The Liverpool Scientists at the forefront of the fight against COVID

North West Tonight 15th February 2021

BBC Radio Merseyside 4th February 2021

Liverpool Echo 24th July 2020 Leading the way with vaccine trials COVID -19

Liverpool Echo May 2020 End of the pandemic' in sight as 500 Mersey health staff test new coronavirus vaccine

Selected publications

  • Liu, Xinxue, Shaw, Robert H, Stuart, Arabella S V, Greenland, Melanie, Aley, Parvinder K, Andrews, Nick J, Cameron, J Claire, Charlton, Sue, Clutterbuck, Elizabeth A, Collins, Andrea, Dinesh, Tanya, England, Anna, Faust, Saul N, Ferreira, Daniela, Finn, Adam, Green, Christopher A, Hallis, Bassam, Heath, Paul T, Hill, Helen, Lambe, Teresa, Lazarus, Rajeka, Libri, Vincenzo, Long, Fei, Mujadidi, Yama F, Plested, Emma L, Provstgaard-Morys, Samuel, Ramasamy, Maheshi N, Ramsay, Mary, Read, Robert C, Robinson, Hannah, Singh, Nisha, Turner, David P J, Turner, Paul J, Walker, Laura L, White, Rachel, Nguyen-Van-Tam, Jonathan S and Snape, Matthew D (2021) 'Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial.'. Lancet, Vol 398, Issue 10303, pp. 856-869.

    Walker, N. et al Detection of SARS-CoV-2 infection by saliva and nasopharyngeal sampling in frontline  healthcare workers: an observational cohort study.

    Emary K. R. W et al., 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 Lancet, 2021 397 (10282) 1351-1362

    Voysey, M., et al 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 397 (10277) 881-891

    Voysey, M., et al., 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, 2020.

    Nikolaou, E., et al Experimental Human Challenge Defines Distinct Pneumococcal Kinetic Profiles and Mucosal Responses between Colonized and Non-Colonized Adults 2021 mBio 12 (1)

    Byrne R.L et al., Saliva Alternative to Upper Respiratory Swabs for SARS-CoV-2 Diagnosis Emerg Inf Dis 2020 26 (11)  2770 - 2771

    Adler, H., et al., Experimental Human Pneumococcal Colonisation in Older Adults is Feasible and Safe, Not Immunogenic. Am J Respir Crit Care Med, 2020. 291 (12) 1989 -1993

    Adler, H., et al., Pneumococcal Colonization in Healthy Adult Research Participants in the Conjugate Vaccine Era, United Kingdom, 2010-2017. J Infect Dis, 2019. 219(12): p. 1989-1993.

    Das, S., et al., Intrapulmonary Pharmacokinetics of Cefepime and Enmetazobactam in Healthy Volunteers: Towards New Treatments for Nosocomial Pneumonia. Antimicrob Agents Chemother, 2020.

    Hales, C., et al., Symptoms associated with influenza vaccination and experimental human pneumococcal colonisation of the nasopharynx. Vaccine, 2020. 38(10): p. 2298-2306.

    Hill, H Risk Adapted Approach – Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care. Part 2 Overcoming Barriers to clinical trials  https://mhrainspectorate.blog.gov.uk/2019/03/28/risk-adapted-approach-neonatal-pharmacokinetic-clinical-trial-of-ciprofloxacin-in-critical-care-part-2/ 2019

    Hill, H  Risk Risk-adapted Approach: Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care – Part 1 Applying Risk Adaptation https://mhrainspectorate.blog.gov.uk/2019/01/31/risk-adapted-approach-neonatal-pharmacokinetic-clinical-trial-of-ciprofloxacin-in-critical-care-part-1/  MHRA Government  Blog 2019

    Jochems, S.P., et al., Innate and adaptive nasal mucosal immune responses following experimental human pneumococcal colonization. J Clin Invest, 2019. 129(10): p. 4523-4538.

    Rylance, J et al., Two Randomised Trials of Effect of Live Attenuated Influenza Vaccine on Pneumococcal Colonisation AM J Respiratory Critical Care Med 2019  199 (9) 1160 -1163

    Mitsi, E., et al., Nasal Pneumococcal Density Is Associated with Microaspiration and Heightened Human Alveolar Macrophage Responsiveness to Bacterial Pathogens. Am J Respir Crit Care Med, 2020. 201(3): p. 335-347.

    Adler H et al., Pneumococcal colonization in healthy adult research participants in the conjugate vaccine era, United Kingdom 2010 -2017 J Infect Dis, 2019 219 ( 12) 1989 -1993

    Nikolaou, E., et al., Minimally Invasive Nasal Sampling in Children Offers Accurate Pneumococcal Colonization Detection. Pediatr Infect Dis J, 2019. 38(11): p. 1147-1149

    Jochems, S.P. et al.,  Inflammation induced by influenza virus impairs human innate immune control of pneumococcus Nat Immunol 2018 19 (12) 1299-1308

    Connor, V., et al., Hands are vehicles for transmission of Streptococcus pneumoniae in novel controlled human infection study. Eur Respir J, 2018. 52(4).

    Hill, H Informed consent in Research Setting in Sumatra Ray and Sue Fitzpatrick Oxford Handbook of Clinical and Healthcare Research 2016  Oxford Medical Handbooks 

    Leroux S et al., Pharmacokinetic Studies in Neonates: The utility of an Opportunistic Sampling Design, Clinical Pharmacokinetics 2015 54 (12) 1273-1285

    Zhao, W., Hill, H., Population pharmacokinetics of ciprofloxacin in neonates and young infants less than three months of age Antimicrob Agents Chemother 2014  58 (11)  6572-80

    Hill, H Risk Adaptive Approach Neonatal Pharmacokinetic Clinical Trials Model Medicines and Health Care Products Agency web site http://forums.mhra.gov.uk/forumdisplay.php?22-Risk-adaptive-approach 2012

    Hill H, et al., Uncertainties in the measurement of blood glucose in paediatric intensive care: Implications for clinical trials of tight glycaemic control Intensive Care Medicine  2011 37 ( 9) 1518 -1524

    Hill H  Evaluation of Distance Learning for Health Workers in Kenya Liverpool School of Tropical Medicine (MSc Dissertation)  2003

    Aindow A, Hill H 2003 Intravenous Drug Guidelines Paediatric Intensive Care Royal Liverpool Children’s Hospital Pharmacy Publication 

    Hill H, Gill A 1997 Analgesia Guidelines in Children - Edited by T Nunn I Choonara  Paediatric and Perinatal Drug Therapy p15 -17 Gemini UK