Enhanced immunogenicity of a respiratory syncytial virus (RSV) F subunit vaccine formulated with the adjuvant GLA-SE in cynomolgus macaques

Vaccine

Volumn 33, Issue 36, 2015, Pages 4472-4478

  Patton, Kathryn ^a,b   Aslam, Shahin ^a,c   Shambaugh, Cindy ^a   Lin, Rui ^a   Heeke, Darren ^a   Frantz, Chris ^a,d   Zuo, Fengrong ^a,e   Esser, Mark T ^a   Paliard, Xavier ^a,f   Lambert, Stacie L ^a  

^a MEDIMMUNE   (United States)

^b BIOMARIN PHARMACEUTICAL INC   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

^d GENENTECH INC   (United States)

^e Medivation Inc   (United States)

^f ULTRAGENYX PHARMACEUTICAL INC   (United States)

Author keywords

Adjuvant; Non human primates; RSV F; Vaccine

Indexed keywords

GAMMA INTERFERON; GLUCOPYRANOSYL LIPID A; IMMUNOGLOBULIN G ANTIBODY; INTERLEUKIN 10; INTERLEUKIN 17; INTERLEUKIN 2; INTERLEUKIN 4; INTERLEUKIN 5; INTERLEUKIN 6; LIPID A; NEUTRALIZING ANTIBODY; RESPIRATORY SYNCYTIAL VIRUS VACCINE; SUBUNIT VACCINE; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; VIRUS FUSION PROTEIN; GLUCOSIDE; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOLOGICAL ADJUVANT; VIRUS ANTIBODY;

ADULT; ANIMAL CELL; ANIMAL EXPERIMENT; ANTIBODY TITER; ARTICLE; CELLULAR IMMUNITY; CONTROLLED STUDY; CYTOKINE RELEASE; EMULSION; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; HUMAN RESPIRATORY SYNCYTIAL VIRUS; HUMORAL IMMUNITY; IMMUNOGENICITY; LIMIT OF DETECTION; LONGEVITY; MACACA FASCICULARIS; MALE; MEMORY CELL; NONHUMAN; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; RNA IMMUNIZATION; TH1 CELL; VIRUS STRAIN; ANIMAL; BLOOD; CROSS REACTION; IMMUNOLOGICAL MEMORY; IMMUNOLOGY; SECRETION (PROCESS); T LYMPHOCYTE; TIME FACTOR; TREATMENT OUTCOME;

ADJUVANTS, IMMUNOLOGIC; ANIMALS; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CROSS REACTIONS; ENZYME-LINKED IMMUNOSPOT ASSAY; GLUCOSIDES; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOLOGIC MEMORY; INTERFERON-GAMMA; LIPID A; MACACA FASCICULARIS; MALE; RESPIRATORY SYNCYTIAL VIRUS VACCINES; RESPIRATORY SYNCYTIAL VIRUSES; T-LYMPHOCYTES; TIME FACTORS; TREATMENT OUTCOME; VACCINES, SUBUNIT;

EID: 84939565904     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.07.025     Document Type: Article

References (30)

1. Tripp R.A. Pathogenesis of respiratory syncytial virus infection. Viral Immunol 2004, 17:165-181. 10.1089/0882824041310513.
2. Falsey A.R., Hennessey P.A., Formica M.A., Cox C., Walsh E.E. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 2005, 352:1749-1759. 10.1056/NEJMoa043951.
3. Mullooly J.P., Bridges C.B., Thompson W.W., Chen J., Weintraub E., Jackson L.A., et al. Influenza- and RSV-associated hospitalizations among adults. Vaccine 2007, 25:846-855. 10.1016/j.vaccine.2006.09.041.
4. Respiratory Syncytial Virus Infection (RSV) Trends and Surveillance, US CDC. [accessed 19.03.15]. http://www.cdc.gov/rsv/research/us-surveillance.html.
5. Hurwitz J.L. Respiratory syncytial virus vaccine development. Expert Rev Vaccines 2011, 10:1415-1433. 10.1586/erv.11.120.
6. Rudraraju R., Jones B.G., Sealy R., Surman S.L., Hurwitz J.L. Respiratory syncytial virus: current progress in vaccine development. Viruses 2013, 5:577-594. 10.3390/v5020577.
7. Kurzweil V., Tang R., Galinski M., Wang K., Zuo F., Cherukuri A., et al. Translational sciences approach to RSV vaccine development. Expert Rev Vaccines 2013, 12:1047-1060. 10.1586/14760584.2013.824706.
8. Falsey A.R., Walsh E.E., Capellan J., Gravenstein S., Zambon M., Yau E., et al. Comparison of the safety and immunogenicity of 2 respiratory syncytial virus (rsv) vaccines - nonadjuvanted vaccine or vaccine adjuvanted with alum - given concomitantly with influenza vaccine to high-risk elderly individuals. J Infect Dis 2008, 198:1317-1326. 10.1086/592168.
9. Piedra P.A., Jewell A.M., Cron S.G., Atmar R.L., Glezen W.P. Correlates of immunity to respiratory syncytial virus (RSV) associated-hospitalization: establishment of minimum protective threshold levels of serum neutralizing antibodies. Vaccine 2003, 21:3479-3482.
10. Walsh E.E., Peterson D.R., Falsey A.R. Risk factors for severe respiratory syncytial virus infection in elderly persons. J Infect Dis 2004, 189:233-238. 10.1086/380907.
11. Lee F.E.-H., Walsh E.E., Falsey A.R., Betts R.F., Treanor J.J. Experimental infection of humans with A2 respiratory syncytial virus. Antiviral Res 2004, 63:191-196. 10.1016/j.antiviral.2004.04.005.
12. Hall C.B., Walsh E.E., Long C.E., Schnabel K.C. Immunity to and frequency of reinfection with respiratory syncytial virus. J Infect Dis 1991, 163:693-698.
13. Hall C.B., Geiman J.M., Biggar R., Kotok D.I., Hogan P.M., Douglas G.R. Respiratory syncytial virus infections within families. N Engl J Med 1976, 294:414-419. 10.1056/NEJM197602192940803.
14. Walsh E.E., Falsey A.R. Age related differences in humoral immune response to respiratory syncytial virus infection in adults. J Med Virol 2004, 73:295-299. 10.1002/jmv.20090.
15. Cherukuri A., Patton K., Gasser R.A., Zuo F., Woo J., Esser M.T., et al. Adults 65 years old and older have reduced numbers of functional memory T cells to respiratory syncytial virus fusion protein. Clin Vaccine Immunol 2013, 20:239-247. 10.1128/CVI. 00580-12.
16. Tang R.S., MacPhail M., Schickli J.H., Kaur J., Robinson C.L., Lawlor H.A., et al. Parainfluenza virus type 3 expressing the native or soluble fusion (F) Protein of Respiratory Syncytial Virus (RSV) confers protection from RSV infection in African green monkeys. J Virol 2004, 78:11198-11207. 10.1128/JVI.78.20.11198-11207.2004.
17. Anderson R.C., Fox C.B., Dutill T.S., Shaverdian N., Evers T.L., Poshusta G.R., et al. Physicochemical characterization and biological activity of synthetic TLR4 agonist formulations. Colloids Surf B: Biointerfaces 2010, 75:123-132. 10.1016/j.colsurfb.2009.08.022.
18. Hancock G.E., Speelman D.J., Heers K., Bortell E., Smith J., Cosco C. Generation of atypical pulmonary inflammatory responses in BALB/c mice after immunization with the native attachment (G) glycoprotein of respiratory syncytial virus. J Virol 1996, 70:7783-7791.
19. Olson M.R., Varga S.M. Pulmonary immunity and immunopathology: lessons from respiratory syncytial virus. Expert Rev Vaccines 2008, 7:1239-1255. 10.1586/14760584.7.8.1239.
20. Coler R.N., Baldwin S.L., Shaverdian N., Bertholet S., Reed S.J., Raman V.S., et al. A synthetic adjuvant to enhance and expand immune responses to influenza vaccines. PLoS ONE 2010, 5:e13677. 10.1371/journal.pone.0013677.
21. Lambert S., Aslam S., Stillman E., MacPhail M., Nelson C., Ro B., et al. A novel RSV F subunit vaccine adjuvanted with GLA-SE elicits robust protective TH1-type humoral and cellular immunity in rodent models. PLOS ONE 2015, 10(3):e0119509. 10.1371/journal.pone.0119509.
22. Patton K., Aslam S., Lin J., Yu L., Lambert S., Dawes G., et al. Enzyme-linked immunospot assay for detection of human respiratory syncytial virus f protein-specific gamma interferon-producing T cells. Clin Vaccine Immunol 2014, 21:628-635. 10.1128/CVI. 00736-13.
23. Walsh P.N., Friedrich D.P., Williams J.A., Smith R.J., Stewart T.L., Carter D.K., et al. Optimization and qualification of a memory B-cell ELISpot for the detection of vaccine-induced memory responses in HIV vaccine trials. J Immunol Methods 2013, 394:84-93. 10.1016/j.jim.2013.05.007.
24. Brown H., Prescott R. Applied mixed models in medicine 1999, John Wiley & Sons, New York. 1st ed.
25. Gardner M.B., Luciw P.A. Macaque models of human infectious disease. ILAR J 2008, 49:220-255.
26. LeBien T.W., Tedder T.F. B lymphocytes: how they develop and function. Blood 2008, 112:1570-1580. 10.1182/blood-2008-02-078071.
27. Walsh E.E., Falsey A.R. Humoral and mucosal immunity in protection from natural respiratory syncytial virus infection in adults. J Infect Dis 2004, 190:373-378. 10.1086/421524.
28. Lambert S.L., Yang C.-F., Liu Z., Sweetwood R., Zhao J., Cheng L., et al. Molecular and cellular response profiles induced by the TLR4 agonist-based adjuvant glucopyranosyl lipid A. PLoS ONE 2012, 7:e51618. 10.1371/journal.pone.0051618.
29. Clegg C.H., Roque R., Van Hoeven N., Perrone L., Baldwin S.L., Rininger J.A., et al. Adjuvant solution for pandemic influenza vaccine production. Proc Natl Acad Sci U S A 2012, 109:17585-17590. 10.1073/pnas.1207308109.
30. Behzad H., Huckriede A.L.W., Haynes L., Gentleman B., Coyle K., Wilschut J.C., et al. GLA-SE, a synthetic toll-like receptor 4 agonist, enhances T-cell responses to influenza vaccine in older adults. J Infect Dis 2012, 205:466-473. 10.1093/infdis/jir769.