Jenner E: An inquiry into the causes and effects of the Variolae vaccinae, a disease discovered in some of the western countries of England, particularly Gloucestershire, and known by the name of “The Cow Pox”. Reprinted by Milan: R Lier & Co, 1923:84 1798.
Darton TC, Blohmke CJ, Moorthy VS, Altmann DM, Hayden FG, Clutterbuck EA, Levine MM, Hill AV, Pollard AJ. Design, recruitment, and microbiological considerations in human challenge studies. Lancet Infect Dis. 2015;15:840–51.
Article
PubMed
Google Scholar
Good clinical practice guide. 3rd ed. London: The Stationary Office; 2014.
The Rules Governing Medicinal Products in the European Union, Guidance on INPS and NIMPs 1 Eudralex 10.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. (Union E ed., vol. 536/2014 Brussels: Official Journal of the European Union; 2014.
Fullen D, Lambkin-Williams R. Risk factors associated with severe clinical outcomes of pandemic H1N1 infection. J Hum Virol Retrovirol. 2014. https://doi.org/10.15406/jhvrv.2014.01.00016.
Article
Google Scholar
Memoli MJ, Shaw PA, Han A, Czajkowski L, Reed S, Athota R, Bristol T, Fargis S, Risos K, Powers JH, et al. Evaluation of antihemagglutinin and antineuraminidase antibodies as correlates of protection in an influenza A/H1N1 virus healthy human challenge model. MBio. 2016;7:e00417.
Article
PubMed
PubMed Central
CAS
Google Scholar
Wilkinson T, Li C, Chui C, Huang A, Perkins M, Liebner J, Lambkin-Williams R, Gilbert A, Oxford J, Nicholas B, et al. Preexisting influenza specific CD4 T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18:274–80.
Article
PubMed
CAS
Google Scholar
Lambkin-Williams R, Gelder C, Broughton R, Mallett CP, Gilbert AS, Mann A, He D, Oxford JS, Burt D. An intranasal proteosome-adjuvanted trivalent influenza vaccine is safe, immunogenic & efficacious in the human viral influenza challenge model. serum IgG & mucosal IgA are important correlates of protection against illness associated with infection. PLoS ONE. 2016;11:e0163089.
Article
PubMed
PubMed Central
CAS
Google Scholar
Tay H, Wark PA, Bartlett NW. Advances in the treatment of virus-induced asthma. Expert Rev Respir Med. 2016;10:629–41.
Article
PubMed
CAS
PubMed Central
Google Scholar
Fullen DJ, Noulin N, Catchpole A, Fathi H, Murray EJ, Mann A, Eze K, Balaratnam G, Borley DW, Gilbert A, Lambkin-Williams R. Accelerating influenza research: vaccines, antivirals, immunomodulators and monoclonal antibodies. the manufacture of a new wild-type H3N2 virus for the human viral challenge model. PLoS ONE. 2016;11:e0145902.
Article
PubMed
PubMed Central
CAS
Google Scholar
Fullen DJ, Murray B, Mori J, Catchpole A, Borley DW, Murray EJ, Balaratnam G, Gilbert A, Mann A, Hughes F, Lambkin-Williams R. A tool for investigating asthma and COPD exacerbations: a newly manufactured and well characterised GMP wild-type human rhinovirus for use in the human viral challenge model. PLoS ONE. 2016;11:e0166113.
Article
PubMed
PubMed Central
CAS
Google Scholar
DeVincenzo JP, Wilkinson T, Vaishnaw A, Cehelsky J, Meyers R, Nochur S, Harrison L, Meeking P, Mann A, Moane E, et al. Viral load drives disease in humans experimentally infected with respiratory syncytial virus. Am J Respir Crit Care Med. 2010;182:1305–14.
Article
PubMed
PubMed Central
CAS
Google Scholar
Sobel Leonard A, McClain MT, Smith GJ, Wentworth DE, Halpin RA, Lin X, Ransier A, Stockwell TB, Das SR, Gilbert AS, et al. Deep sequencing of influenza A virus from a human challenge study reveals a selective bottleneck and only limited intrahost genetic diversification. J Virol. 2016;90:11247–58.
Article
PubMed
PubMed Central
CAS
Google Scholar
Robertson JS, Engelhardt OG. Developing vaccines to combat pandemic influenza. Viruses. 2010;2:532–46.
Article
PubMed
PubMed Central
CAS
Google Scholar
FDA: Guidance for industry characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications. Research CfBEa ed.: Office of Communication, Outreach and Development; 2010.
ICH: ICH harmonised tripartite guideline: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R1). In International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use: ICH; 1999.
PTC: Points to consider in the characterization of cell lines used to produce biologicals. Rockville, MD; 1993.
HO: Evaluation of cell substrates for the production of biologicals: revision of WHO recommendations. In Report of the WHO Study Group on cell substrates for the production of biologicals; 2000.
The Rules Governing Medicinal Products in the European Union. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/chapter_5.pdf.
CPMP: CPMP position statement on DNA and host cell proteins (HCP) impurities, routine testing verses validation studies. London; 1997.
Fullen DJ, Noulin N, Catchpole A, Fathi H, Murray EJ, Mann A, Eze K, Balaratnam G, Borley DW, Gilbert A, Lambkin-Williams R. Correction: accelerating influenza research: vaccines, antivirals, immunomodulators and monoclonal antibodies. The manufacture of a new wild-type H3N2 virus for the human viral challenge model. PLoS ONE. 2016;11:e0157211.
Article
PubMed
PubMed Central
CAS
Google Scholar
Cass L, Ito K, Charron C, Strong P, Norton C, Gilbert A, Lambkin-Williams R, Mann A, Rapeport G. RV568, a narrow spectrum kinase inhibitor (NSKI), inhibits virus induced nasal interleukin-8 (IL8) in the human viral challenge model where healthy adult male volunteers were experimentally inoculated with live respiratory syncytial virus. Eur Respir J. 1970;2013:42.
Google Scholar
DeVincenzo J, Cehelsky J, Foote K, Nochur S, Vaishnaw A, Lambkin-Williams R, Meeking P, Mann A, Moane E, Studholme B, et al.: Early clinical evaluation of an RNA interference (RNAi) based therapy for respiratory syncytial virus (RSV) infection. Pediatr Acad Soc. 2007: 616295.
DeVincenzo J, Lambkin-Williams R, Wilkinson T, Cehelsky J, Nochur S, Walsh E, Meyers R, Gollob J, Vaishnaw A. A randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus. Proc Natl Acad Sci USA. 2010;107:8800–5.
Article
PubMed
PubMed Central
Google Scholar
DeVincenzo JP, McClure MW, Symons JA, Fathi H, Westland C, Chanda S, Lambkin-Williams R, Smith P, Zhang Q, Beigelman L, et al. Activity of oral ALS-008176 in a respiratory syncytial virus challenge study. N Engl J Med. 2015;373:2048–58.
Article
PubMed
CAS
Google Scholar
DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, et al. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014;371:711–22.
Article
PubMed
CAS
Google Scholar
McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, et al. Safety and efficacy of MHAA4549A, a broadly neutralizing monoclonal antibody, in a human influenza a challenge model: a phase 2 randomized trial. Antimicrob Agents Chemother. 2017. https://doi.org/10.1128/AAC.01154-17.
Article
PubMed
PubMed Central
Google Scholar
Pleguezuelos O, Robinson S, Fernandez A, Stoloff GA, Mann A, Gilbert A, Balaratnam G, Wilkinson T, Lambkin-Williams R, Oxford J, Caparros-Wanderley W. A synthetic influenza virus vaccine induces a cellular immune response that correlates with reduction in symptomatology and virus shedding in a randomized phase Ib live-virus challenge in humans. Clin Vaccine Immunol. 2015;22:828–35.
Article
PubMed
PubMed Central
CAS
Google Scholar
Bagga B, Woods CW, Veldman TH, Gilbert A, Mann A, Balaratnam G, Lambkin-Williams R, Oxford JS, McClain MT, Wilkinson T, et al. Comparing influenza and RSV viral and disease dynamics in experimentally infected adults predicts clinical effectiveness of RSV antivirals. Antivir Ther. 2013;18:785–91.
Article
PubMed
CAS
Google Scholar
Burke TW, Henao R, Soderblom E, Tsalik EL, Thompson JW, McClain MT, Nichols M, Nicholson BP, Veldman T, Lucas JE, et al. Nasopharyngeal protein biomarkers of acute respiratory virus infection. EBioMedicine. 2017;17:172–81.
Article
PubMed
PubMed Central
Google Scholar
Killingley B, Enstone JE, Greatorex J, Gilbert AS, Lambkin-Williams R, Cauchemez S, Katz JM, Booy R, Hayward A, Oxford J, et al. Use of a human influenza challenge model to assess person-to-person transmission: proof-of-concept study. J Infect Dis. 2012;205:35–43.
Article
PubMed
Google Scholar
McClain MT, Henao R, Williams J, Nicholson B, Veldman T, Hudson L, Tsalik EL, Lambkin-Williams R, Gilbert A, Mann A, et al. Differential evolution of peripheral cytokine levels in symptomatic and asymptomatic responses to experimental influenza virus challenge. Clin Exp Immunol. 2016;183:441–51.
Article
PubMed
CAS
Google Scholar
McClain MT, Park LP, Nicholson B, Veldman T, Zaas AK, Turner R, Lambkin-Williams R, Gilbert AS, Ginsburg GS, Woods CW. Longitudinal analysis of leukocyte differentials in peripheral blood of patients with acute respiratory viral infections. J Clin Virol. 2013;58:689–95.
Article
PubMed
CAS
Google Scholar
Wilkinson T, Pleguezuelos O, Robinson S, Stoloff G, Lambkin-Williams R, Oxford J, Mann A, Gilbert A, Caparros-Wanderley W. Induction of protective T cell immunity against influenza using a novel peptide vaccine. Eur Respir J. 2012;40:P2534.
Google Scholar
Woods CW, McClain MT, Chen M, Zaas AK, Nicholson BP, Varkey J, Veldman T, Kingsmore SF, Huang Y, Lambkin-Williams R, et al. A host transcriptional signature for presymptomatic detection of infection in humans exposed to influenza H1N1 or H3N2. PLoS ONE. 2013;8:e52198.
Article
PubMed
PubMed Central
CAS
Google Scholar
Zaas AK, Chen M, Varkey J, Veldman T, Hero AO 3rd, Lucas J, Huang Y, Turner R, Gilbert A, Lambkin-Williams R, et al. Gene expression signatures diagnose influenza and other symptomatic respiratory viral infections in humans. Cell Host Microbe. 2009;6:207–17.
Article
PubMed
PubMed Central
CAS
Google Scholar