Consortium team members, expertise and associated project responsibilities

Alex Mann

Organisation Lead

Director, Clinical Sciences, hVIVO, HIC-Vac Investigator

Alex has been working in multiple different aspects of the concept, design, delivery and data analysis of viral CHIM studies for over 18 years, investigating RSV, Influenza, and HRV in both healthy younger volunteers, as well as RSV in 60-75-year-old volunteers and HRV in subjects with asthma. Further, regarding manufacturing infectious challenge agents, Alex has had key roles in developing Influenza, HRV, and RSV challenge agents including taking through preclinical and clinical testing. He led on deriving strategies with QPs for the manufacturing of Influenza strains (H3N2 and H5N1 LPAI) ensuring that the viruses were appropriately assessed and tested (e.g. adventitious agents) to mitigate risk and enable QP release for human characterisation. Alex has managed the design and ethics submission of a Norovirus challenge, which while it did not proceed into clinic, allowed hVIVO to understand the scientific and operational requirements of the Norovirus challenge model, as well as the challenges faced in growing and utilising Norovirus as a challenge agent.

Alan Bell

Scientific Advisor Role

Director, Clinical Sciences, hVIVO

Over the last 12+ years Alan has worked on both the laboratory and clinical utilisation of GMP and non-GMP challenge agents as part of academic and commercial early phase clinical development in various disease populations. Alan has designed trials, authored challenge agent dossiers, overseen dilution and reconstitution and clinically administered agents nasally and bronchially such as lyophilised lipopolysaccharide (Escherichia coli serotype O26:B6) in healthy subjects and COPD patients; Respiratory Syncytial Virus (RSV) in older healthy subjects aged 60-74 years; Human Rhino Virus (HRV-16) in asthmatic patients; Allergens including but not limited to American and European house dust mite, grass pollen, birch tree pollen and cat dander to asthmatic patients; Methacholine, Histamine, Adenosine mono-phosphate, and Mannitol in asthma patients; Capsaicin for use in asthma and chronic cough patients. Alan was also involved in the sourcing, manufacturing and clinical use in the first commercial trial to administer Adenosine triphosphate in healthy subjects, asthma patients and patients with chronic cough disorder. This required a challenge agent dossier containing the source of the agent, outline of the manufacturing process, an audit of the manufacturing premises, review of quality controls, batch variation analysis and a risk and safety assessment. Subsequent reconstituted dilutions used from the validated stock had retention samples tested to establish stability at decreasing concentrations enabling QP release for use in an incremental human bronchial challenge.

Andrew Catchpole

Scientific Advisor Role

Director, Clinical Sciences, hVIVO

Andrew has been working in multiple different aspects of the design, delivery and data analysis of viral CHIM studies for over 15 years. This has incorporated several leadership roles, which includes having had the responsibility for the production and control of hVIVO’s viral challenge stocks for the past 7 years. In this role, Andrew has led the technical strategy and project management associated with the GMP manufacture, adventitious testing and subsequent clinical characterisation of an RSV and 2 different influenza viral challenge agents, the programmes of which incorporated both cell and egg substrates. Furthermore, he has had pivotal roles in the development of 2 different HRV challenge stocks and the safety testing and clinical utilisation of another RSV stock. He has had a leading role on scientific and regulatory audits at 5 different challenge virus manufacturing sites both in Europe and the US as well as overseen the planning and conduct of diluting and aliquoting existing challenge virus stocks both within a GMP environment as well as enabling conduct outside of GMP environment through appropriate risk assessment and control measure implementation.

Carine La

Deputy lead

Associate Director, Clinical Sciences

Carine La has been working in multiple projects regarding drug development from preclinical to Phase 1 stage. Her contribution was key in the setup and the management of consortium while discussing with stakeholders with different profiles (industrial, researchers, clinicians, Technology Transfer officers…). She successfully managed some key grant applications (France, Europe), some being granted. Her knowledge in innovation methodologies helped to shape an innovative business model for a start-up she co-founded in 2012 and successfully launched the first in situ DNA testing toolkit for testing phytoplasmas and plant viruses. Carine is today involved in GMP manufacturing and maintenance of viral challenge agents.

Kawsar Talaat

Organisation Lead

Assistant Professor, Department of International Health

Kawsar Talaat is an Assistant Professor in the Department of International Health, Johns Hopkins Bloomberg School of Public Health. She holds a joint appointment in the Johns Hopkins School of Medicine. A physician, Dr. Talaat is board-certified in Internal Medicine, Pediatrics and Infectious Diseases. Over the last 13 years, she has served as the Principal Investigator for Phase 1 or 2 trials for a variety of vaccines, including influenza (pandemic and seasonal), enteric pathogens including Enterotoxigenic E. coli and Shigella, malaria and Ebola as a faculty member in the Center for Immunization Research. Currently she is engaged in Phase 3 clinical trials of candidate SARS-CoV-2 vaccines. In addition to her extensive experience in the design and conduct of clinical vaccine trials, Dr. Talaat conducts controlled human infection studies for a variety of organisms, including Enterotoxigenic E. coli, Shigella and Respiratory Syncytial Virus. Human challenge studies are useful tools to help determine if a therapeutic or a vaccine will be effective quickly and early in its development. She is currently part of a Gates Foundation-WHO working group convened around the pathway to licensure and WHO prequalification of upcoming Shigella vaccines.

Meta Roestenberg

Organisation Lead

Leiden University Medical Center, Department of Parasitology

Meta Roestenberg is physician-scientist working as a scientist at the research laboratories of the department of Parasitology and as clinician within the department of Infectious Diseases. She studied Medicine at the University of Maastricht, where she obtained her medical degree cum laude in 2004. During her medical training she had the opportunity to follow internships in Africa and South-East Asia, where she became fascinated by infectious diseases. She returned to India for additional training several months after her graduation and then decided to dedicate her professional career to poverty related infectious diseases. She completed her PhD cum laude in 2013 at the department of Medical Microbiology of the Radboud University Medical Center where she developed a human model for malaria immunity. She was trained in internal medicine at the Radboud University Medical Center and the Canisius Wilhelmina Hospital, both in Nijmegen. In 2014 she registered as Infectious Diseases specialist at the Leiden University Medical Center and was awarded a VENI grant from the Dutch Society for Scientific Research and a Gisela Thier fellowship in order to pursue translational research into the interaction between malaria parasites and the skin. She now leads a research group of translational scientists, investigating the efficacy of a genetically attenuated malaria vaccine and developing human models for Schistosoma mansoni and Necator americanus. In the future, Meta will continue to focus on clinical translational vaccine research to fight infectious diseases that cause significant morbidity and mortality among the poorest people in the world.

Angela Van Diepen

Scientific Adviser Role

Leiden University Medical Center, Department of Parasitology

Dr. Angela van Diepen is a scientist specialized in host-pathogen interactions with special interest in Schistosoma infections and host immune responses to parasite glycans. Since 2010 she joined the group of Prof. dr. C.H. Hokke within the department of Parasitology of the Leiden University Medical Center to study various aspects of Schistosoma infections in relation to vaccine development and the improvement and development of diagnostic tests for schistosomiasis. She has been involved in various studies including the recent controlled human Schistosoma infection studies at the Leiden Controlled Human Infection Center lead by dr. Meta Roestenberg.

Peter Kremsner

Organisation Lead

President of Cermel, Director at Turbingen University

Since 2011 Peter G. Kremsner and his team have been working on the development of Plasmodium falciparum sporozoites (PfSPZ)-based vaccines in cooperation with Sanaria Inc. using the Controlled Human Malaria Infection model, which they established for the development of drugs and vaccines against malaria. The first volunteer at the Institute of Tropical Medicine, Tübingen, received cryopreserved PfSPZ by intravenous administration in 2012. Many Phase I-III trials with more than thousand volunteers were conducted in Tübingen and in Gabon, accelerating the better understanding of the nature of malaria infection and vaccine development.