WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23–24 March 2015

Abstract

Respiratory syncytial virus (RSV) is a globally prevalent cause of lower respiratory infection in neonates and infants. Despite its disease burden, a safe and effective RSV vaccine has remained elusive. In recent years, improved understanding of RSV biology and innovations in immunogen design has resulted in the advancement of multiple vaccine candidates into the clinical development pipeline. Given the growing number of vaccines in clinical trials, the rapid pace at which they are being tested, and the likelihood that an RSV vaccine will reach the commercial market in the next 5-10 years, consensus and guidance on clinical development pathways and licensure routes are needed now, before large-scale efficacy trials commence. In pursuit of this aim, the World Health Organization convened the first RSV vaccine consultation in 15 years on the 23rd and 24th of March, 2015 in Geneva, Switzerland. The meeting's primary objective was to provide guidance on clinical endpoints and development pathways for vaccine trials with a focus on considerations of low- and middle-income countries. Meeting participants reached consensus on candidate case definitions for RSV disease, considerations for clinical efficacy endpoints, and the clinical development pathway for active and passive immunization trials in maternal and pediatric populations. The strategic focus of this meeting was on the development of high quality, safe and efficacious RSV preventive interventions for global use and included: (1) maternal/passive immunization to prevent RSV disease in infants less than 6 months; (2) pediatric immunization to prevent RSV disease in infants and young children once protection afforded by maternal immunization wanes.

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References 40

1. 1.

   Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. 2013.

   Not in our library

2. 2.

   Johnson JE, Gonzales RA, Olson SJ, Wright PF, Graham BS. The histopathology of fatal untreated human respiratory syncytial virus infection. Mod Pathol. 2007;20:108.

   Not in our library10.1038/modpathol.3800725

3. 3.

   Pickles RJ, DeVincenzo JP. Respiratory syncytial virus (RSV) and its propensity for causing bronchiolitis. J Pathol. 2015;235:266.

   Not in our library10.1002/path.4462

4. 4.

   Chin J, Magoffin RL, Shearer LA, Schieble JH, Lennette EH. Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population. Am J Epidemiol. 1969;89:449.

   Not in our library10.1093/oxfordjournals.aje.a120957

5. 5.

   Fulginiti VA, et al. Respiratory virus immunization. I. A field trial of two inactivated respiratory virus vaccines; an aqueous trivalent parainfluenza virus vaccine and an alum-precipitated respiratory syncytial virus vaccine. Am J Epidemiol. 1969;89:435.

   Not in our library10.1093/oxfordjournals.aje.a120956

6. 6.

   Kapikian AZ, Mitchell RH, Chanock RM, Shvedoff RA, Stewart CE. An epidemiologic study of altered clinical reactivity to respiratory syncytial (RS) virus infection in children previously vaccinated with an inactivated RS virus vaccine. Am J Epidemiol. 1969;89:405.

   Not in our library10.1093/oxfordjournals.aje.a120954

7. 7.

   Kim HW, et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. Am J Epidemiol. 1969;89:422.

   Not in our library10.1093/oxfordjournals.aje.a120955

8. 8.

   Polack FP, et al. A role for immune complexes in enhanced respiratory syncytial virus disease. J Exp Med. 2002;196:859.

   Not in our library10.1084/jem.20020781

9. 9.

   Murphy BR, et al. Dissociation between serum neutralizing and glycoprotein antibody responses of infants and children who received inactivated respiratory syncytial virus vaccine. J Clin Microbiol. 1986;24:197.

   Not in our library10.1128/jcm.24.2.197-202.1986

10. 10.
    RSV Vaccine-Enhanced Disease Is Orchestrated by the Combined Actions of Distinct CD4 T Cell Subsets · 2015

    No notice
11. 11.

    Graham BS, et al. Priming immunization determines T helper cytokine mRNA expression patterns in lungs of mice challenged with respiratory syncytial virus. J Immunol. 1993;151:2032.

    Not in our library

12. 12.

    McLellan JS, et al. Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus. Science. 2013;342:592.

    Not in our library10.1126/science.1243283

13. 13.

    McLellan JS, et al. Structure of RSV fusion glycoprotein trimer bound to a prefusion-specific neutralizing antibody. Science. 2013;340:1113.

    Not in our library10.1126/science.1234914

14. 14.

    Guvenel AK, Chiu C, Openshaw PJ. Current concepts and progress in RSV vaccine development. Expert Rev Vaccines. 2014;13:333.

    Not in our library10.1586/14760584.2014.878653

15. 15.

    Prince GA, Hemming VG, Horswood RL, Chanock RM. Immunoprophylaxis and immunotherapy of respiratory syncytial virus infection in the cotton rat. Virus Res. 1985;3:193.

    Not in our library10.1016/0168-1702(85)90045-0

16. 16.

    Shaw CA, et al. The path to an RSV vaccine. Curr Opin Virol. 2013;3:332.

    Not in our library10.1016/j.coviro.2013.05.003

17. 17.

    Taylor G. Bovine model of respiratory syncytial virus infection. Curr Top Microbiol Immunol. 2013;372:327.

    Not in our library10.1007/978-3-642-38919-1_16

18. 18.

    de Moraes-Pinto MI, et al. Placental transfer and maternally acquired neonatal IgG immunity in human immunodeficiency virus infection. J Infect Dis. 1996;173:1077.

    Not in our library10.1093/infdis/173.5.1077

19. 19.

    Okoko BJ, et al. The influence of placental malaria infection and maternal hypergammaglobulinemia on transplacental transfer of antibodies and IgG subclasses in a rural West African population. J Infect Dis. 2001;184:627.

    Not in our library10.1086/322808

20. 20.

    Karron RA, Buchholz UJ, Collins PL. Live-attenuated respiratory syncytial virus vaccines. Curr Top Microbiol Immunol. 2013;372:259.

    Not in our library10.1007/978-3-642-38919-1_13

21. 21.

    Siegrist C-A, Orenstein Walter A, Plotkin Stanley A, Offit Paul A. Vaccine immunology. Vaccines. 2013.

    Not in our library

22. 22.

    Meng J, Lee S, Hotard AL, Moore ML. Refining the balance of attenuation and immunogenicity of respiratory syncytial virus by targeted codon deoptimization of virulence genes. mBio. 2014;5:e01704.

    Not in our library10.1128/mbio.01704-14

23. 23.
    Latitudinal Variations in Seasonal Activity of Influenza and Respiratory Syncytial Virus (RSV): A Global Comparative Review · 2013

    No notice
24. 24.

    Haynes AK, et al. Respiratory syncytial virus circulation in seven countries with Global Disease Detection Regional Centers. J Infect Dis. 2013;208(Suppl 3):S246.

    Not in our library10.1093/infdis/jit515

25. 25.

    Hsu CH, et al. Prolonged seasonality of respiratory syncytial virus infection among preterm infants in a subtropical climate. PLoS ONE. 2014;9:e110166.

    Not in our library10.1371/journal.pone.0110166

26. 26.

    Nair H, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010;375:1545.

    Not in our library10.1016/s0140-6736(10)60206-1

27. 27.

    Behrendt CE, Decker MD, Burch DJ, Watson PH, International RSV Study Group. International variation in the management of infants hospitalized with respiratory syncytial virus. Eur J Pediatr. 1998;157:215.

    Not in our library10.1007/s004310050798

28. 28.

    Nokes DJ, et al. Incidence and severity of respiratory syncytial virus pneumonia in rural Kenyan children identified through hospital surveillance. Clin Infect Dis. 2009;49:1341.

    Not in our library10.1086/606055

29. 29.

    Robertson SE, et al. Respiratory syncytial virus infection: denominator-based studies in Indonesia, Mozambique, Nigeria and South Africa. Bull World Health Organ. 2004;82:914.

    Not in our library

30. 30.
    The Source of Respiratory Syncytial Virus Infection In Infants: A Household Cohort Study In Rural Kenya · 2013

    No notice
31. 31.

    Glenn GM, et al. Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Vaccine. 2013;31:524.

    Not in our library10.1016/j.vaccine.2012.11.009

32. 32.

    Raghunandan R, et al. An insect cell derived respiratory syncytial virus (RSV) F nanoparticle vaccine induces antigenic site II antibodies and protects against RSV challenge in cotton rats by active and passive immunization. Vaccine. 2014;32:6485.

    Not in our library10.1016/j.vaccine.2014.09.030

33. 33.

    Gomez M, et al. 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. 2009;28:655.

    Not in our library10.1097/inf.0b013e318199c3b1

34. 34.

    Bernstein DI, et al. 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. 2012;31:109.

    Not in our library10.1097/inf.0b013e31823386f1

35. 35.

    Malkin E, et al. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS ONE. 2013;8:e77104.

    Not in our library10.1371/journal.pone.0077104

36. 36.

    Soares-Weiser K, et al. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev. 2012;11.

    Not in our library10.1002/14651858.cd008521.pub3

37. 37.

    European Medicines Agency. Guideline of clinical evaluation of new vaccines. 2006.

    Not in our library

38. 38.

    Feldman AS, He Y, Moore ML, Hershenson MB, Hartert TV. Toward primary prevention of asthma reviewing the evidence for early-life respiratory viral infections as modifiable risk factors to prevent childhood asthma. Am J Respir Crit Care Med. 2015;191:34.

    Not in our library10.1164/rccm.201405-0901pp

39. 39.

    Regnier SA, Huels J. Association between respiratory syncytial virus hospitalizations in infants and respiratory sequelae: systematic review and meta-analysis. Pediatr Infect Dis J. 2013;32:820.

    Not in our library10.1097/inf.0b013e31829061e8

40. 40.

    Eric T, Simoes CAF, Jeffrey Chow, Sonbol Shahid-Salles, Ramanan Laxminarayan, Jacob John T. Acute respiratory infections in children. Disease control priorities in developing countries. 2006.

    Not in our library

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• Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study · 2017
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