Norovirus vaccine against experimental human Norwalk virus illness

New England Journal of Medicine

Volumn 365, Issue 23, 2011, Pages 2178-2187

  Atmar, Robert L ^a   Bernstein, David I ^b   Harro, Clayton D ^c   Al Ibrahim, Mohamed S ^d   Chen, Wilbur H ^e   Ferreira, Jennifer ^f   Estes, Mary K ^a   Graham, David Y ^a   Opekun, Antone R ^a   Richardson, Charles ^g   Mendelman, Paul M ^g  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

^b UNIVERSITY OF CINCINNATI   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d SNBL Clinical Pharmacology Center   (United States)

^e UNIVERSITY OF MARYLAND   (United States)

^f EMMES   (United States)

^g Ligocyte Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHITOSAN; IMMUNOGLOBULIN A; NOROVIRUS VACCINE; PHOSPHORYL LIPID A; PLACEBO; UNCLASSIFIED DRUG; VIRUS VACCINE;

ABDOMINAL CRAMP; ADULT; ANOREXIA; ANTIBODY BLOOD LEVEL; ARTICLE; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EPISTAXIS; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; MALAISE; MALE; MULTICENTER STUDY; NASAL DISCHARGE; NASAL DISCOMFORT; NASAL PRURITUS; NASAL STUFFINESS; NAUSEA; NORMAL HUMAN; NOROVIRUS; NOSE DISEASE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SNEEZING; VIRAL GASTROENTERITIS; VIRUS STRAIN; VOMITING;

EID: 83155182848     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1101245     Document Type: Article

References (38)

1. Glass RI, Parashar UD, Estes MK. Norovirus gastroenteritis. N Engl J Med 2009;361:1776-85.
2. Adler JL, Zickl R. Winter vomiting disease. J Infect Dis 1969;119:668-73.
3. Dolin R, Blacklow NR, DuPont H, et al. Biological properties of Norwalk agent of acute infectious nonbacterial gastroenteritis. Proc Soc Exp Biol Med 1972;140:578-83.
4. Graham DY, Jiang X, Tanaka T, Opekun AR, Madore HP, Estes MK. Norwalk virus infection of volunteers: new insights based on improved assays. J Infect Dis 1994;170:34-43. (Pubitemid 24186422)
5. Parrino TA, Schreiber DS, Trier JS, Kapikian AZ, Blacklow NR. Clinical immunity in acute gastroenteritis caused by Norwalk agent. N Engl J Med 1977;297:86-9. (Pubitemid 8122844)
6. Hutson AM, Airaud F, LePendu J, Estes MK, Atmar RL. Norwalk virus infection associates with secretor status genotyped from sera. J Med Virol 2005;77:116-20. (Pubitemid 41076487)
7. Lindesmith L, Moe C, Marionneau S, et al. Human susceptibility and resistance to Norwalk virus infection. Nat Med 2003;9:548-53. (Pubitemid 36597100)
8. Hutson AM, Atmar RL, Estes MK. Norovirus disease: changing epidemiology and host susceptibility factors. Trends Microbiol 2004;12:279-87. (Pubitemid 38686376)
9. Tan M, Jiang X. Norovirus gastroenteritis, carbohydrate receptors, and animal models. PLoS Pathog 2010;6(8):e1000983.
10. Hutson AM, Atmar RL, Marcus DM, Estes MK. Norwalk virus-like particle hemagglutination by binding to H histo-blood group antigens. J Virol 2003;77:405-15. (Pubitemid 36004980)
11. Hutson AM, Atmar RL, Graham DY, Estes MK. Norwalk virus infection and disease is associated with ABO histo-blood group type. J Infect Dis 2002;185:1335-7. (Pubitemid 34439142)
12. Reeck A, Kavanagh O, Estes MK, et al. Serological correlate of protection against norovirus-induced gastroenteritis. J Infect Dis 2010;202:1212-8.
13. Jiang X, Wang M, Graham DY, Estes MK. Expression, self-assembly, and antigenicity of the Norwalk virus capsid protein. J Virol 1992;66:6527-32.
14. Ball JM, Hardy ME, Atmar RL, Conner ME, Estes MK. Oral immunization with recombinant Norwalk virus-like particles induces a systemic and mucosal immune response in mice. J Virol 1998;72:1345-53. (Pubitemid 28116920)
15. Guerrero RA, Ball JM, Krater SS, Pacheco SE, Clements JD, Estes MK. Recombinant Norwalk virus-like particles administered intranasally to mice induce systemic and mucosal (fecal and vaginal) immune responses. J Virol 2001;75:9713-22. (Pubitemid 32900106)
16. El-Kamary SS, Pasetti MF, Mendelman PM, et al. Adjuvanted intranasal Norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues. J Infect Dis 2010;202:1649-58. [Erratum, J Infect Dis 2011;203:1036.]
17. Atmar RL, Opekun AR, Gilger MA, et al. Norwalk virus shedding after experimental human infection. Emerg Infect Dis 2008;14:1553-7.
18. Kojima S, Kageyama T, Fukushi S, et al. Genogroup-specific PCR primers for detection of Norwalk-like viruses. J Virol Methods 2002;100:107-14. (Pubitemid 34003629)
19. Kavanagh O, Estes MK, Reeck A, et al. Serological responses to experimental Norwalk virus infection measured using a quantitative duplex time-resolved fluorescence immunoassay. Clin Vaccine Immunol 2011;18:1187-90.
20. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes. Scand J Infect Dis 1990;22:259-67.
21. Patel MM, Widdowson MA, Glass RI, Akazawa K, Vinjé J, Parashar UD. Systematic literature review of role of noroviruses in sporadic gastroenteritis. Emerg Infect Dis 2008;14:1224-31.
22. Scallan E, Hoekstra RM, Angulo FJ, et al. Foodborne illness acquired in the United States - major pathogens. Emerg Infect Dis 2011;17:7-15.
23. Johnson PC, Mathewson JJ, Dupont HL, Greenberg HB. Multiple-challenge study of host susceptibility to Norwalk gastroenteritis in US adults. J Infect Dis 1990;161:18-21. (Pubitemid 20021850)
24. Ball JM, Graham DY, Opekun AR, Gilger MA, Guerrero RA, Estes MK. Recombinant Norwalk virus-like particles given orally to volunteers: phase I study. Gastroenterology 1999;117:40-8. (Pubitemid 29297618)
25. Tacket CO, Sztein MB, Losonsky GA, Wasserman SS, Estes MK. Humoral, mucosal, and cellular immune responses to oral Norwalk virus-like particles in volunteers. Clin Immunol 2003;108:241-7. (Pubitemid 37117370)
26. Couch RB, Kasel JA, Six TH, Cate TR, Zahradnik JM. Immunological reactions and resistance to infection with influenza virus. In: Stuart-Harris C, Potter CW, eds. The molecular virology and epidemiology of influenza. New York: Academic Press, 1984:119-44.
27. Franco MA, Angel J, Greenberg HB. Immunity and correlates of protection for rotavirus vaccines. Vaccine 2006;24:2718-31.
28. Joura EA, Kjaer SK, Wheeler CM, et al. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine 2008;26:6844-51.
29. Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol 2010;17:1055-65.
30. Baldridge JR, McGowan P, Evans JT, et al. Taking a Toll on human disease: toll-like receptor 4 agonists as vaccine adjuvants and monotherapeutic agents. Expert Opin Biol Ther 2004;4:1129-38. (Pubitemid 38937554)
31. Persing DH, Coler RN, Lacy MJ, et al. Taking toll: lipid A mimetics as adjuvants and immunomodulators. Trends Microbiol 2002;10:Suppl:S32-S37.
32. Abreu MT, Thomas LS, Arnold ET, Lukasek K, Michelsen KS, Arditi M. TLR signaling at the intestinal epithelial interface. J Endotoxin Res 2003;9:322-30.
33. Frey S, Treanor JJ, Atmar RL, et al. Phase 1 dosage escalation, safety and immunogenicity study of a bivalent norovirus VLP vaccine by the intramuscular route. Presented at the Annual Meeting of the Infectious Diseases Society of America, Boston, October 20-23, 2011. abstract.
34. Le Guyader FS, Krol J, Ambert-Balay K, et al. Comprehensive analysis of a norovirus-associated gastroenteritis outbreak, from the environment to the consumer. J Clin Microbiol 2010;48:915-20.
35. Lindesmith LC, Donaldson E, Leon J, et al. Heterotypic humoral and cellular immune responses following Norwalk virus infection. J Virol 2010;84:1800-15.
36. Siebenga JJ, Vennema H, Renckens B, De Bruin E, et al. Epochal evolution of GGII.4 norovirus capsid proteins from 1995 to 2006. J Virol 2007;81:9932-41. (Pubitemid 350067696)
37. Bull RA, Eden JS, Rawlinson WD, White PA. Rapid evolution of pandemic noroviruses of the GII.4 lineage. PLoS Pathog 2010;6(3):e1000831.
38. Iritani N, Vennema H, Siebenga JJ, et al. Genetic analysis of the capsid gene of genotype GII.2 noroviruses. J Virol 2008;82:7336-45. (Pubitemid 352031202)