Ongoing developments in RSV prophylaxis: a clinician's analysis

Current Opinion in Virology

Volumn 24, Issue , 2017, Pages 70-78

  Rezaee, Fariba ^a   Linfield, Debra T ^a   Harford, Terri J ^a   Piedimonte, Giovanni ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; LIVE VACCINE; PALIVIZUMAB; PROTEIN; RESPIRATORY SYNCYTIAL VIRUS VACCINE; INACTIVATED VACCINE; MONOCLONAL ANTIBODY;

ANTIVIRAL THERAPY; CLINICAL TRIAL (TOPIC); DRUG DELIVERY SYSTEM; DRUG EFFICACY; HUMAN; IMMUNOPROPHYLAXIS; INFECTION PREVENTION; NONHUMAN; PRIORITY JOURNAL; RESPIRATORY SYNCYTIAL VIRUS INFECTION; REVIEW; ANIMAL; DRUG EFFECTS; HOSPITALIZATION; HUMAN RESPIRATORY SYNCYTIAL VIRUS; IMMUNOLOGY; INFANT; MOUSE; PHYSIOLOGY; PRE-EXPOSURE PROPHYLAXIS; RISK FACTOR; VACCINE IMMUNOGENICITY; VIROLOGY;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; HOSPITALIZATION; HUMANS; IMMUNOGENICITY, VACCINE; INFANT; MICE; PALIVIZUMAB; PRE-EXPOSURE PROPHYLAXIS; RESPIRATORY SYNCYTIAL VIRUS INFECTIONS; RESPIRATORY SYNCYTIAL VIRUS VACCINES; RESPIRATORY SYNCYTIAL VIRUS, HUMAN; RISK FACTORS; VACCINES, INACTIVATED;

EID: 85019120898     PISSN: 18796257     EISSN: 18796265     Source Type: Journal    
DOI: 10.1016/j.coviro.2017.03.015     Document Type: Review

References (60)

1. 1• Geoghegan, S., Erviti, A., Caballero, M.T., Vallone, F., Zanone, S.M., Losada, J.V., Bianchi, A., Acosta, P.L., Talarico, L.B., Ferretti, A., et al. Mortality due to respiratory syncytial virus. Burden and risk factors. Am. J Respir. Crit. Care Med. 195 (2017), 96–103 Recent paper reporting a prospective, multicenter study on burden and risk factors for mortality due to RSV infection.
2. 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. 352 (2005), 1749–1759.
3. 3•• Hall, C.B., Weinberg, G.A., Iwane, M.K., Blumkin, A.K., Edwards, K.M., Staat, M.A., Auinger, P., Griffin, M.R., Poehling, K.A., Erdman, D., et al. The burden of respiratory syncytial virus infection in young children. N. Engl. J. Med. 360 (2009), 588–598 Highly cited, comprehensive study of the RSV related problems among young children from three geographically diverse populations.
4. 4 McClure, D.L., Kieke, B.A., Sundaram, M.E., Simpson, M.D., Meece, J.K., Sifakis, F., Gasser, R.A. Jr, Belongia, E.A., Seasonal incidence of medically attended respiratory syncytial virus infection in a community cohort of adults >/=50 years old. PLoS One, 9, 2014, e102586.
5. 5 Wu, P., Hartert, T.V., Evidence for a causal relationship between respiratory syncytial virus infection and asthma. Expert Rev. Anti Infect. Ther. 9 (2011), 731–745.
6. 6 Gilca, R., De Serres, G., Tremblay, M., Vachon, M.L., Leblanc, E., Bergeron, M.G., Dery, P., Boivin, G., Distribution and clinical impact of human respiratory syncytial virus genotypes in hospitalized children over 2 winter seasons. J. Infect. Dis. 193 (2006), 54–58.
7. 7•• Piedimonte, G., RSV infections: state of the art. Clevel. Clin. J. Med. 82 (2015), S13–S18 Comprehensive overview of RSV structure, virology, clinical manifestation, and its relation to subsequent recurrent wheezing and asthma.
8. 8 Sabogal, C., Auais, A., Napchan, G., Mager, E., Zhou, B.G., Suguihara, C., Bancalari, E., Piedimonte, G., Effect of respiratory syncytial virus on apnea in weanling rats. Pediatr. Res. 57 (2005), 819–825.
9. 9•• Meissner, H.C., Viral bronchiolitis in children. N. Engl. J. Med. 374 (2016), 62–72 A recent paper reviewing pathogenesis of viral bronchiolitis, host and environmental factors. It summarizes recent American Academy of Pediatrics guidelines for diagnosis, management, and prevention of bronchiolitis.
10. 10 American Academy of Pediatrics Committee on Infectious D, American Academy of Pediatrics Bronchiolitis Guidelines C, Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 134 (2014), e620–638.
11. 11• Byington, C.L., Wilkes, J., Korgenski, K., Sheng, X., Respiratory syncytial virus-associated mortality in hospitalized infants and young children. Pediatrics 135 (2015), e24–e31 Using two national data sources, this paper reviews mortality, morbidity and healthcare cost associated with RSV infection in infants and young children.
12. 12 Sanchez-Solis, M., Gartner, S., Bosch-Gimenez, V., Garcia-Marcos, L., Is palivizumab effective as a prophylaxis of respiratory syncytial virus infections in cystic fibrosis patients? A meta-analysis. Allergol. Immunopathol. (Madr.) 43 (2015), 298–303.
13. 13 Blount, R.E. Jr, Morris, J.A., Savage, R.E., Recovery of cytopathogenic agent from chimpanzees with coryza. Proc. Soc. Exp. Biol. Med. 92 (1956), 544–549.
14. 14•• Acosta, P.L., Caballero, M.T., Polack, F.P., Brief history and characterization of enhanced respiratory syncytial virus disease. Clin. Vaccine Immunol. 23 (2015), 189–195 A review describing the immunological basis and role of T-helper bias on enhanced RSV disease (ERD) resulted from formalin-inactivated RSV vaccine and how it applies to selecting different strategies for current vaccine candidates.
15. 15 Knudson, C.J., Hartwig, S.M., Meyerholz, D.K., Varga, S.M., RSV vaccine-enhanced disease is orchestrated by the combined actions of distinct CD4 T cell subsets. PLoS Pathog., 11, 2015, e1004757.
16. 16 Wright, M., Piedimonte, G., Respiratory syncytial virus prevention and therapy: past, present, and future. Pediatr. Pulmonol. 46 (2011), 324–347.
17. 17 American Academy of Pediatrics Committee on Infectious Diseases, Use of ribavirin in the treatment of respiratory syncytial virus infection. Pediatrics 92 (1993), 501–504.
18. 18 DeVincenzo, J.P., Whitley, R.J., Mackman, R.L., 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. 371 (2014), 711–722.
19. 19 DeVincenzo, J.P., McClure, M.W., Symons, J.A., 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. 373 (2015), 2048–2058.
20. 20 DeVincenzo, J.P., McClure, M.W., Fry, J., ALS-008176 for respiratory syncytial virus infection. N. Engl. J. Med. 374 (2016), 1391–1392.
21. 21 Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. The PREVENT Study Group. Pediatrics 99 (1997), 93–99.
22. 22 Roymans, D., Koul, A., Treatment of respiratory syncytial virus infection: past, present and future. Resch, B., (eds.) Human Respiratory Syncytial Virus Infection, 2011, InTech.
23. 23• American Academy of Pediatrics Committee on Infectious D, American Academy of Pediatrics Bronchiolitis Guidelines C, Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 134 (2014), 415–420 The most recent guidelines regarding the use of palivizumab to reduce the risk of RSV infection in high risk infants. Compared to the guidelines issued in 2012, this one further restricts which infants should receive the prophylaxis. Palivizumab was previously recommended to use in infants born at <32 weeks, but is now restricted to infants born at <29 weeks. The use of palivizumab in infants with hemodynamically significant congenital heart disease is recommended for children <12 months old instead of 24 months old.
24. 24 Meissner, H.C., More on viral bronchiolitis in children. N. Engl. J. Med., 375, 2016, 1200.
25. 25 Weisman, L.E., Motavizumab, a second-generation humanized mAb for the prevention of respiratory syncytial virus infection in high-risk populations. Curr. Opin. Mol. Ther. 11 (2009), 208–218.
26. 26 O'Brien, K.L., Chandran, A., Weatherholtz, R., Jafri, H.S., Griffin, M.P., Bellamy, T., Millar, E.V., Jensen, K.M., Harris, B.S., Reid, R., et al. Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial. Lancet Infect. Dis. 15 (2015), 1398–1408.
27. 27•• Roberts, J.N., Graham, B.S., Karron, R.A., Munoz, F.M., Falsey, A.R., Anderson, L.J., Marshall, V., Kim, S., Beeler, J.A., Challenges and opportunities in RSV vaccine development: meeting report from FDA/NIH workshop. Vaccine 34 (2016), 4843–4849 Summary of expert RSV Vaccines Workshop in Bethesda 2016, reviewing challenges in RSV vaccine development, such as clinically indicators of vaccine impact on severity of disease and the risk of enhanced respiratory disease (ERD).
28. 28 Wright, P.F., Karron, R.A., Belshe, R.B., Shi, J.R., Randolph, V.B., Collins, P.L., O'Shea, A.F., Gruber, W.C., Murphy, B.R., The absence of enhanced disease with wild type respiratory syncytial virus infection occurring after receipt of live, attenuated, respiratory syncytial virus vaccines. Vaccine 25 (2007), 7372–7378.
29. 29•• Karron, R.A., Wright, P.F., Belshe, R.B., Thumar, B., Casey, R., Newman, F., Polack, F.P., Randolph, V.B., Deatly, A., Hackell, J., et al. Identification of a recombinant live attenuated respiratory syncytial virus vaccine candidate that is highly attenuated in infants. J. Infect. Dis. 191 (2005), 1093–1104 Comprehensive overview of the advantages and disadvantages, as well as the current clinical trials, for live-attenuated RSV vaccines.
30. 30 Le Nouen, C., McCarty, T., Brown, M., Smith, M.L., Lleras, R., Dolan, M.A., Mehedi, M., Yang, L., Luongo, C., Liang, B., Munir, S., DiNapoli, J.M., Mueller, S., Wimmer, E., Collins, P.L., Buchholz, U.J., Genetic stability of genome-scale deoptimized RNA virus vaccine candidates under selective pressure. Proc. Natl. Acad. Sci. U. S. A., 2017, 10.1073/pnas.1619242114 PubMed PMID: 28049853.
31. 31 Karron, R.A., Buchholz, U.J., Collins, P.L., Live-attenuated respiratory syncytial virus vaccines. Curr. Top. Microbiol. Immunol. 372 (2013), 259–284.
32. 32 Bermingham, A., Collins, P.L., The M2-2 protein of human respiratory syncytial virus is a regulatory factor involved in the balance between RNA replication and transcription. Proc. Natl. Acad. Sci. U. S. A. 96 (1999), 11259–11264.
33. 33 McFarland EK, R: Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID ΔM2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age. Edited by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO), Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); 2016:16-20.
34. 34 Bukreyev, A., Whitehead, S.S., Murphy, B.R., Collins, P.L., Recombinant respiratory syncytial virus from which the entire SH gene has been deleted grows efficiently in cell culture and exhibits site-specific attenuation in the respiratory tract of the mouse. J. Virol. 71 (1997), 8973–8982.
35. 35 Fuentes, S., Tran, K.C., Luthra, P., Teng, M.N., He, B., Function of the respiratory syncytial virus small hydrophobic protein. J. Virol. 81 (2007), 8361–8366.
36. 36 Techaarpornkul, S., Barretto, N., Peeples, M.E., Functional analysis of recombinant respiratory syncytial virus deletion mutants lacking the small hydrophobic and/or attachment glycoprotein gene. J. Virol. 75 (2001), 6825–6834.
37. 37 Luongo, C., Winter, C.C., Collins, P.L., Buchholz, U.J., Respiratory syncytial virus modified by deletions of the NS2 gene and amino acid S1313 of the L polymerase protein is a temperature-sensitive, live-attenuated vaccine candidate that is phenotypically stable at physiological temperature. J. Virol. 87 (2013), 1985–1996.
38. 38 Malkin, E., Yogev, R., Abughali, N., Sliman, J., Wang, C.K., Zuo, F., Yang, C.F., Eickhoff, M., Esser, M.T., Tang, R.S., et al. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One, 8, 2013, e77104.
39. 39 Rostad, C.A., Stobart, C.C., Gilbert, B.E., Pickles, R.J., Hotard, A.L., Meng, J., Blanco, J.C., Moin, S.M., Graham, B.S., Piedra, P.A., et al. A recombinant respiratory syncytial virus vaccine candidate attenuated by a low-fusion F protein is immunogenic and protective against challenge in cotton rats. J. Virol. 90 (2016), 7508–7518.
40. 40 Stobart, C.C., Rostad, C.A., Ke, Z., Dillard, R.S., Hampton, C.M., Strauss, J.D., Yi, H., Hotard, A.L., Meng, J., Pickles, R.J., et al. A live RSV vaccine with engineered thermostability is immunogenic in cotton rats despite high attenuation. Nat. Commun, 7, 2016, 13916.
41. 41 Cunningham CK, R. A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age. Edited by: Regulatory Compliance and Human Subjects Protection Branch (RCHSPB), Division of Clinical Research (DCR)/Office of the Director (OD), The National Institute of Allergy and Infectious Diseases (NIAID), The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); 2013:10-20.
42. 42 Liesman, R.M., Buchholz, U.J., Luongo, C.L., Yang, L., Proia, A.D., DeVincenzo, J.P., Collins, P.L., Pickles, R.J., RSV-encoded NS2 promotes epithelial cell shedding and distal airway obstruction. J. Clin. Invest. 124 (2014), 2219–2233.
43. 43 Yang, C.F., Wang, C.K., Malkin, E., Schickli, J.H., Shambaugh, C., Zuo, F., Galinski, M.S., Dubovsky, F., Study Group, Tang, R.S., Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine. Vaccine 31 (2013), 2822–2827.
44. 44 Gomez, M., Mufson, M.A., Dubovsky, F., Knightly, C., Zeng, W., Losonsky, G., Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children. Pediatr. Infect. Dis. J. 28 (2009), 655–658.
45. 45 Bernstein, D.I., Malkin, E., Abughali, N., Falloon, J., Yi, T., Dubovsky, F., Investigators, M.-C., Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr. Infect. Dis. J. 31 (2012), 109–114.
46. 46 Pierantoni, A., Esposito, M.L., Ammendola, V., Napolitano, F., Grazioli, F., Abbate, A., Del Sorbo, M., Siani, L., D'Alise, A.M., Taglioni, A., et al. Mucosal delivery of a vectored RSV vaccine is safe and elicits protective immunity in rodents and nonhuman primates. Mol. Ther. Methods Clin. Dev., 2, 2015, 15018.
47. 47•• Anderson, L.J., Dormitzer, P.R., Nokes, D.J., Rappuoli, R., Roca, A., Graham, B.S., Strategic priorities for respiratory syncytial virus (RSV) vaccine development. Vaccine 31:Suppl 2 (2013), B209–B215 Discusses the goals, and safety and efficacy concerns for each target population and the considerations for different vaccination strategies.
48. 48 Jorquera, P.A., Tripp, R.A., Synthetic biodegradable microparticle and nanoparticle vaccines against the respiratory syncytial virus. Vaccines (Basel), 4, 2016.
49. 49 Widjojoatmodjo, M.N., Bogaert, L., Meek, B., Zahn, R., Vellinga, J., Custers, J., Serroyen, J., Radosevic, K., Schuitemaker, H., Recombinant low-seroprevalent adenoviral vectors Ad26 and Ad35 expressing the respiratory syncytial virus (RSV) fusion protein induce protective immunity against RSV infection in cotton rats. Vaccine 33 (2015), 5406–5414.
50. 50 Green, C.A., Scarselli, E., Voysey, M., Capone, S., Vitelli, A., Nicosia, A., Cortese, R., Thompson, A.J., Sande, C.S., de Lara, C., et al. Safety and immunogenicity of novel respiratory syncytial virus (RSV) vaccines based on the RSV viral proteins F, N and M2-1 encoded by simian adenovirus (PanAd3-RSV) and MVA (MVA-RSV); protocol for an open-label, dose-escalation, single-centre, phase 1 clinical trial in healthy adults. BMJ Open, 5, 2015, e008748.
51. 51 Green, C.A., Scarselli, E., Sande, C.J., Thompson, A.J., de Lara, C.M., Taylor, K.S., Haworth, K., Del Sorbo, M., Angus, B., Siani, L., et al. Chimpanzee adenovirus- and MVA-vectored respiratory syncytial virus vaccine is safe and immunogenic in adults. Sci. Transl. Med., 7, 2015, 300ra126.
52. 52 Timm, A., Enzinger, C., Felder, E., Chaplin, P., Genetic stability of recombinant MVA-BN. Vaccine 24 (2006), 4618–4621.
53. 53 Chu, H.Y., Steinhoff, M.C., Magaret, A., Zaman, K., Roy, E., Langdon, G., Formica, M.A., Walsh, E.E., Englund, J.A., Respiratory syncytial virus transplacental antibody transfer and kinetics in mother-infant pairs in Bangladesh. J. Infect. Dis. 210 (2014), 1582–1589.
54. 54 Munoz, F.M., Respiratory syncytial virus in infants: is maternal vaccination a realistic strategy?. Curr. Opin. Infect. Dis. 28 (2015), 221–224.
55. 55•• Brown, P.M., Harford, T.J., Agrawal, V., Yen-Lieberman, B., Rezaee, F., Piedimonte, G., Prenatal exposure to respiratory syncytial virus alters postnatal immunity and airway smooth muscle contractility during early-life reinfections. PLoS One, 12, 2017, e0168786 Highlights the effect of RSV infection during pregnancy on offspring. By using a rodent model of RSV infection, this paper investigates the mechanisms by which maternal RSV infection alters postnatal immunity, such as changing lower airway immune cell patterns and increasing contractility of airway smooth muscle.
56. 56 Glenn, G.M., Fries, L.F., Smith, G., Kpamegan, E., Lu, H., Guebre-Xabier, M., Hickman, S.P., Flyer, D., Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine 33 (2015), 6488–6492.
57. 57 Glenn, G.M., Fries, L.F., Thomas, D.N., Smith, G., Kpamegan, E., Lu, H., Flyer, D., Jani, D., Hickman, S.P., Piedra, P.A., A randomized, blinded, controlled, dose-ranging study of a respiratory syncytial virus recombinant fusion (F) nanoparticle vaccine in healthy women of childbearing age. J. Infect. Dis. 213 (2016), 411–422.
58. 58 Krarup, A., Truan, D., Furmanova-Hollenstein, P., Bogaert, L., Bouchier, P., Bisschop, I.J., Widjojoatmodjo, M.N., Zahn, R., Schuitemaker, H., McLellan, J.S., et al. A highly stable prefusion RSV F vaccine derived from structural analysis of the fusion mechanism. Nat. Commun., 6, 2015, 8143.
59. 59• Broadbent, L., Groves, H., Shields, M.D., Power, U.F., Respiratory syncytial virus, an ongoing medical dilemma: an expert commentary on respiratory syncytial virus prophylactic and therapeutic pharmaceuticals currently in clinical trials. Influenza Other Respir. Viruses 9 (2015), 169–178 Reviews RSV-specific prophylactic, therapeutic candidates, as well as RSV vaccines that entered clinical trials between 2008 and 2015.
60. 60 Falloon, J., Ji, F., Curtis, C., Bart, S., Sheldon, E., Krieger, D., Dubovsky, F., Lambert, S., Takas, T., Villafana, T., et al. A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant. Vaccine 34 (2016), 2847–2854.