Validation of the wild-type influenza a human challenge model H1N1pdMIST: An A(H1N1) pdm09 dose-finding investigational new drug study

Clinical Infectious Diseases

Volumn 60, Issue 5, 2015, Pages 693-702

  Memoli, Matthew J ^a   Czajkowski, Lindsay ^a   Reed, Susan ^a   Athota, Rani ^a   Bristol, Tyler ^a   Proudfoot, Kathleen ^a   Fargis, Sarah ^a   Stein, Matthew ^a   Dunfee, Rebecca L ^a   Shaw, Pamela A ^b   Davey, Richard T ^a   Taubenberger, Jeffery K ^a  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Challenge; H1N1; Healthy volunteer; Influenza; Influenza A

Indexed keywords

ANTIBODY; GUANOSINE PHOSPHATE; INFLUENZA VACCINE;

2009 H1N1 INFLUENZA; ADULT; ANTIBODY TITER; ARTICLE; CLINICAL RESEARCH; CONVALESCENCE; COST EFFECTIVENESS ANALYSIS; DISEASE SEVERITY; FEMALE; FEVER; HOSPITAL ADMISSION; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; INFLUENZA A (H1N1); MALE; NORMAL HUMAN; NOSE OBSTRUCTION; PATHOGENESIS; PATIENT CARE; PRIORITY JOURNAL; REVERSE GENETICS; RHINORRHEA; TISSUE CULTURE; VALIDATION STUDY; VIRUS SHEDDING; VIRUS STRAIN; VOLUNTEER; ADOLESCENT; ANIMAL; CLINICAL TRIAL; INFLUENZA; INFLUENZA A VIRUS (H1N1); INTRANASAL DRUG ADMINISTRATION; ISOLATION AND PURIFICATION; MIDDLE AGED; PATHOLOGY; PROSPECTIVE STUDY; UNITED STATES; VIROLOGY; YOUNG ADULT;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANIMALS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA, HUMAN; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; UNITED STATES; VIRUS SHEDDING; YOUNG ADULT;

EID: 84935480388     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciu924     Document Type: Article

References (37)

1. Morens DM, Taubenberger JK, Fauci AS. H7N9 avian influenza Avirus and the perpetual challenge of potential human pandemicity. mBio 2013; 4. doi:10.1128/mBio.00445-13.
2. Garten RJ, Davis CT, Russell CA, et al. Antigenic and genetic characteristics of swine-origin 2009 A(H1N1) influenza viruses circulating in humans. Science 2009; 325:197-201.
3. Centers for Disease C, Prevention. Estimates of deaths associated with seasonal influenza-United States, 1976-2007. MMWR Morb Mortal Wkly Rep 2010; 59:1057-62.
4. Hayden FG. Newer influenza antivirals, biotherapeutics and combinations. Influenza Other Respir Viruses 2013; 7(suppl 1):63-75.
5. Hayden FG. Experimental human influenza: observations from studies of influenza antivirals. Antivir Ther 2012; 17(1 pt B):133-41.
6. Smorodintseff AA, Tushinsky MD, Drobyshevskaya AI, Korovin AA, Osetroff AI. Investigation on volunteers infected with the influenza virus. Am J Med Sci 1937; 194:159-70.
7. Francis F. Intranasal inoculation of human individuals with the virus of epidemic influenza. P Soc Exp Biol Med 1940; 43:337-9.
8. Anderson MJ, Heath RB. Cell mediated immunity in experimental influenza and parainfluenza infection. Dev Biol Stand 1977; 39:379-83.
9. Brown TA, Murphy BR, Radl J, Haaijman JJ, Mestecky J. Subclass distribution and molecular form of immunoglobulin A hemagglutinin antibodies in sera and nasal secretions after experimental secondary infection with influenza A virus in humans. J Clin Microbiol 1985; 22:259-64.
10. Carrat F, Vergu E, Ferguson NM, et al. Time lines of infection and disease in human influenza: a review of volunteer challenge studies. Am J Epidemiol 2008; 167:775-85.
11. Clements ML, Snyder MH, Buckler-White AJ, Tierney EL, London WT, Murphy BR. Evaluation of avian-human reassortant influenza A/Washington/ 897/80 x A/Pintail/119/79 virus in monkeys and adult volunteers. J Clin Microbiol 1986; 24:47-51.
12. Cretescu L, Beare AS, Schild GC. Formation of antibody to matrix protein in experimental human influenza A virus infections. Infect Immun 1978; 22:322-7.
13. Dolin R, Richman DD, Murphy BR, Fauci AS. Cell-mediated immune responses in humans after induced infection with influenza A virus. J Infect Dis 1977; 135:714-9.
14. Hayden FG, Fritz R, Lobo MC, Alvord W, Strober W, Straus SE. Local and systemic cytokine responses during experimental human influenza A virus infection. Relation to symptom formation and host defense. J Clin Invest 1998; 101:643-9.
15. Kasel JA, Alford RH, Knight V, Waddell GH, Sigel MM. Experimental infection of human volunteers with equine influenza virus. Nature 1965; 206:41-3.
16. Kasel JA, Couch RB. Experimental infection in man and horses with influenza A viruses. Bull World Health Organ 1969; 41:447-52.
17. Rudenko LG, Shadrin AS, Geiker VI, Zibina EA, Zykov MP. Associated seroconversions to respiratory viruses in volunteers with experimental influenza infection. Acta Virol 1976; 20:135-41.
18. Scheinberg M, Blacklow NR, Goldstein AL, Parrino TA, Rose FB, Cathcart ES. Influenza: response of T-cell lymphopenia to thymosin. N Engl J Med 1976; 294:1208-11.
19. Snyder MH, Clements ML, Herrington D, London WT, Tierney EL, Murphy BR. Comparison by studies in squirrel monkeys, chimpanzees, and adult humans of avian-human influenza A virus reassortants derived from different avian influenza virus donors. J Clin Microbiol 1986; 24:467-9.
20. Alford RH, Kasel JA, Gerone PJ, Knight V. Human influenza resulting from aerosol inhalation. Proc Soc Exp Biol Med 1966; 122:800-4.
21. Hayden FG, Treanor JJ, Fritz RS, et al. Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA 1999; 282: 1240-6.
22. Hayden FG, Jennings L, Robson R, et al. Oral oseltamivir in human experimental influenza B infection. Antivir Ther 2000; 5:205-13.
23. Barroso L, Treanor J, Gubareva L, Hayden FG. Efficacy and tolerability of the oral neuraminidase inhibitor peramivir in experimental human influenza: randomized, controlled trials for prophylaxis and treatment. Antivir Ther 2005; 10:901-10.
24. Gubareva LV, Kaiser L, Matrosovich MN, Soo-Hoo Y, Hayden FG. Selection of influenza virus mutants in experimentally infected volunteers treated with oseltamivir. J Infect Dis 2001; 183:523-31.
25. Gentile DA, Doyle WJ, Fireman P, Skoner DP. Effect of experimental influenza A infection on systemic immune and inflammatory parameters in allergic and nonallergic adult subjects. Ann Allergy Asthma Immunol 2001; 87:496-500.
26. Huang KY, Li CK, Clutterbuck E, et al. Virus-specific antibody secreting cell, memory B-cell, and sero-antibody responses in the human influenza challenge model. J Infect Dis 2014; 209:1354-61.
27. Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med 2012; 18:274-80.
28. Killingley B, Enstone JE, Greatorex J, et al. Use of a human influenza challenge model to assess person-to-person transmission: proof-ofconcept study. J Infect Dis 2012; 205:35-43.
29. Jones S, Evans K, McElwaine-Johnn H, et al. DNA vaccination protects against an influenza challenge in a double-blind randomised placebocontrolled phase 1b clinical trial. Vaccine 2009; 27:2506-12.
30. Yewdell JW. To dream the impossible dream: universal influenza vaccination. Curr Opin Virol 2013; 3:316-21.
31. Fodor E, Devenish L, Engelhardt OG, Palese P, Brownlee GG, Garcia-Sastre A. Rescue of influenza A virus from recombinant DNA. J Virol 1999; 73:9679-82.
32. Potter CW, Oxford JS. Determinants of immunity to influenza infection in man. Br Med Bull 1979; 35:69-75.
33. Wan H, Gao J, Xu K, et al. Molecular basis for broad neuraminidase immunity: conserved epitopes in seasonal and pandemic H1N1 as well as H5N1 influenza viruses. J Virol 2013; 87:9290-300.
34. Krafft AE, Russell KL, Hawksworth AW, et al. Evaluation of PCR testing of ethanol-fixed nasal swab specimens as an augmented surveillance strategy for influenza virus and adenovirus identification. J Clin Microbiol 2005; 43:1768-75.
35. Memoli MJ, Athota R, Reed S, et al. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis 2014; 58:214-24.
36. Richman DD, Murphy BR, Baron S, Uhlendorf C. Three strains of influenza A virus (H3N2): interferon sensitivity in vitro and interferon production in volunteers. J Clin Microbiol 1976; 3:223-6.
37. Murphy BR, Kasel JA, Chanock RM. Association of serum antineuraminidase antibody with resistance to influenza in man. N Engl J Med 1972; 286:1329-32.