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Volumn 5, Issue 10, 2015, Pages

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

Author keywords

[No Author keywords available]

Indexed keywords

RESPIRATORY SYNCYTIAL VIRUS PROTEIN F; RESPIRATORY SYNCYTIAL VIRUS PROTEIN M2 1; RESPIRATORY SYNCYTIAL VIRUS PROTEIN N; RESPIRATORY SYNCYTIAL VIRUS VACCINE; UNCLASSIFIED DRUG; VIRUS PROTEIN; VIRAL PROTEIN;

EID: 84949524619     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2015-008748     Document Type: Article
Times cited : (57)

References (44)
  • 1
    • 0022589125 scopus 로고
    • Risk of primary infection and reinfection with respiratory syncytial virus
    • Glezen WP, Taber LH, Frank AL, et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child 1986;140:543-6.
    • (1986) Am J Dis Child , vol.140 , pp. 543-546
    • Glezen, W.P.1    Taber, L.H.2    Frank, A.L.3
  • 2
    • 59749095702 scopus 로고    scopus 로고
    • The burden of respiratory syncytial virus infection in young children
    • Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009;360:588-98.
    • (2009) N Engl J Med , vol.360 , pp. 588-598
    • Hall, C.B.1    Weinberg, G.A.2    Iwane, M.K.3
  • 3
    • 0347320558 scopus 로고    scopus 로고
    • The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area
    • Deshpande SA, Northern V. The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area. Arch Dis Child 2003;88:1065-9.
    • (2003) Arch Dis Child , vol.88 , pp. 1065-1069
    • Deshpande, S.A.1    Northern, V.2
  • 4
    • 0031683919 scopus 로고    scopus 로고
    • Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants
    • [No authors listed]
    • [No authors listed]. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. The IMpact-RSV Study Group. Pediatrics 1998;102(3 Pt 1):531-7.
    • (1998) The IMpact-RSV Study Group. Pediatrics , vol.102 , Issue.3 , pp. 531-537
  • 5
    • 0033638924 scopus 로고    scopus 로고
    • Rates of hospitalization for respiratory syncytial virus infection among children in medicaid
    • Boyce TG, Mellen BG, Mitchel EF Jr, et al. Rates of hospitalization for respiratory syncytial virus infection among children in medicaid. J Pediatr 2000;137:865-70.
    • (2000) J Pediatr , vol.137 , pp. 865-870
    • Boyce, T.G.1    Mellen, B.G.2    Mitchel, E.F.3
  • 7
    • 81555228664 scopus 로고    scopus 로고
    • Progress in understanding and controlling respiratory syncytial virus: Still crazy after all these years
    • Collins PL, Melero JA. Progress in understanding and controlling respiratory syncytial virus: still crazy after all these years. Virus Res 2011;162:80-99.
    • (2011) Virus Res , vol.162 , pp. 80-99
    • Collins, P.L.1    Melero, J.A.2
  • 8
    • 84871570086 scopus 로고    scopus 로고
    • The risk of mortality among young children hospitalized for severe respiratory syncytial virus infection
    • Szabo SM, Gooch KL, Bibby MM, et al. The risk of mortality among young children hospitalized for severe respiratory syncytial virus infection. Paediatr Respir Rev 2013;13(Suppl 2):S1-8.
    • (2013) Paediatr Respir Rev , vol.13 , pp. S1-8
    • Szabo, S.M.1    Gooch, K.L.2    Bibby, M.M.3
  • 9
    • 84871036375 scopus 로고    scopus 로고
    • Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: A systematic analysis for the global burden of disease study 2010
    • Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2095-128.
    • (2012) Lancet , vol.380 , pp. 2095-2128
    • Lozano, R.1    Naghavi, M.2    Foreman, K.3
  • 10
    • 77951653074 scopus 로고    scopus 로고
    • Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: A systematic review and meta-Analysis
    • Nair H, Nokes DJ, Gessner BD, 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;375:1545-55.
    • (2011) Lancet , vol.375 , pp. 1545-1555
    • Nair, H.1    Nokes, D.J.2    Gessner, B.D.3
  • 11
    • 84877600733 scopus 로고    scopus 로고
    • Respiratory syncytial virus and recurrent wheeze in healthy preterm infants
    • Blanken MO, Rovers MM, Molenaar JM, et al. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. N Engl J Med 2013;368:1791-9.
    • (2013) N Engl J Med , vol.368 , pp. 1791-1799
    • Blanken, M.O.1    Rovers, M.M.2    Molenaar, J.M.3
  • 12
    • 77958471150 scopus 로고    scopus 로고
    • Asthma and allergy patterns over 18 years after severe RSV bronchiolitis in the first year of life
    • Sigurs N, Aljassim F, Kjellman B, et al. Asthma and allergy patterns over 18 years after severe RSV bronchiolitis in the first year of life. Thorax 2010;65:1045-52.
    • (2011) Thorax , vol.65 , pp. 1045-1052
    • Sigurs, N.1    Aljassim, F.2    Kjellman, B.3
  • 13
    • 84898608474 scopus 로고    scopus 로고
    • Risk factors for hospital admission with RSV bronchiolitis in England: A population-based birth cohort study
    • Murray J, Bottle A, Sharland M, et al. Risk factors for hospital admission with RSV bronchiolitis in England: a population-based birth cohort study. PLoS ONE 2014;9:e89186.
    • (2014) PLoS ONE , vol.9 , pp. e89186
    • Murray, J.1    Bottle, A.2    Sharland, M.3
  • 14
    • 22544466450 scopus 로고    scopus 로고
    • Symptomatic respiratory syncytial virus infection in previously healthy young adults living in a crowded military environment
    • O'Shea MK, Ryan MA, Hawksworth AW, et al. Symptomatic respiratory syncytial virus infection in previously healthy young adults living in a crowded military environment. Clin Infect Dis 2005;41:311-17.
    • (2005) Clin Infect Dis , vol.41 , pp. 311-317
    • O'Shea, M.K.1    Ryan, M.A.2    Hawksworth, A.W.3
  • 15
    • 0035885147 scopus 로고    scopus 로고
    • Respiratory syncytial virus infections in previously healthy working adults
    • Hall CB, Long CE, Schnabel KC. Respiratory syncytial virus infections in previously healthy working adults. Clin Infect Dis 2001;33:792-6.
    • (2001) Clin Infect Dis , vol.33 , pp. 792-796
    • Hall, C.B.1    Long, C.E.2    Schnabel, K.C.3
  • 16
    • 84880399352 scopus 로고    scopus 로고
    • Mortality rates of human metapneumovirus and respiratory syncytial virus lower respiratory tract infections in hematopoietic cell transplantation recipients
    • Renaud C, Xie H, Seo S, et al. Mortality rates of human metapneumovirus and respiratory syncytial virus lower respiratory tract infections in hematopoietic cell transplantation recipients. Biol Blood Marrow Transplant 2013;19:1220-6.
    • (2013) Biol Blood Marrow Transplant , vol.19 , pp. 1220-1226
    • Renaud, C.1    Xie, H.2    Seo, S.3
  • 17
    • 84884922064 scopus 로고    scopus 로고
    • High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections
    • Lee N, Lui GC, Wong KT, et al. High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections. Clin Infect Dis 2013;57:1069-77.
    • (2013) Clin Infect Dis , vol.57 , pp. 1069-1077
    • Lee, N.1    Lui, G.C.2    Wong, K.T.3
  • 18
    • 0037425564 scopus 로고    scopus 로고
    • Mortality associated with influenza and respiratory syncytial virus in the United States
    • Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003;289:179-86.
    • (2003) JAMA , vol.289 , pp. 179-186
    • Thompson, W.W.1    Shay, D.K.2    Weintraub, E.3
  • 19
    • 0038350757 scopus 로고    scopus 로고
    • Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001 results from the Palivizumab Outcomes Registry
    • Parnes C, Guillermin J, Habersang R, et al. Palivizumab prophylaxis of respiratory syncytial virus disease in 2000-2001: results from The Palivizumab Outcomes Registry. Pediatr Pulmonol 2003;35:484-9.
    • Pediatr Pulmonol , vol.2003 , Issue.35 , pp. 484-489
    • Parnes, C.1    Guillermin, J.2    Habersang, R.3
  • 20
    • 17644392071 scopus 로고    scopus 로고
    • Respiratory syncytial virus infection in elderly and high-risk adults
    • Falsey AR, Hennessey PA, Formica MA, et al. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 2005;352:1749-59.
    • (2005) N Engl J Med , vol.352 , pp. 1749-1759
    • Falsey, A.R.1    Hennessey, P.A.2    Formica, M.A.3
  • 21
    • 0014493107 scopus 로고
    • 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
    • Fulginiti VA, Eller JJ, Sieber OF, 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;89:435-48.
    • (1969) Am J Epidemiol , Issue.89 , pp. 435-448
    • Fulginiti, V.A.1    Eller, J.J.2    Sieber, O.F.3
  • 22
    • 0014495251 scopus 로고
    • Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine
    • Kim HW, Canchola JG, Brandt CD, et al. Respiratory syncytial virus disease in infants despite prior administration of antigenic inactivated vaccine. Am J Epidemiol 1969;89:422-34.
    • (1969) Am J Epidemiol , vol.89 , pp. 422-434
    • Kim, H.W.1    Canchola, J.G.2    Brandt, C.D.3
  • 23
    • 0014493282 scopus 로고
    • An epidemiologic study of altered clinical reactivity to respiratory syncytial (RS) virus infection in children previously vaccinated with an inactivated RS virus vaccine
    • Kapikian AZ, Mitchell RH, Chanock RM, et al. 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;89:405-21.
    • (1969) Am J Epidemiol , vol.89 , pp. 405-421
    • Kapikian, A.Z.1    Mitchell, R.H.2    Chanock, R.M.3
  • 24
    • 0014495164 scopus 로고
    • Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population
    • Chin J, Magoffin RL, Shearer LA, et al. Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population. Am J Epidemiol 1969;89:449-63.
    • (1969) Am J Epidemiol , vol.89 , pp. 449-463
    • Chin, J.1    Magoffin, R.L.2    Shearer, L.A.3
  • 25
    • 0030250348 scopus 로고    scopus 로고
    • Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP-2) in ambulatory adults over age 60
    • Falsey AR, Walsh EE. Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP-2) in ambulatory adults over age 60. Vaccine 1996;14:1214-18.
    • (1996) Vaccine , vol.14 , pp. 1214-1218
    • Falsey, A.R.1    Walsh, E.E.2
  • 26
    • 0030793204 scopus 로고    scopus 로고
    • Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP-2) in the institutionalized elderly
    • Falsey AR, Walsh EE. Safety and immunogenicity of a respiratory syncytial virus subunit vaccine (PFP-2) in the institutionalized elderly. Vaccine 1997;15:1130-2.
    • (1997) Vaccine , vol.15 , pp. 1130-1132
    • Falsey, A.R.1    Walsh, E.E.2
  • 27
    • 0026572710 scopus 로고
    • Pulmonary eosinophilic response to respiratory syncytial virus infection in mice sensitized to the major surface glycoprotein G
    • Openshaw PJ, Clarke SL, Record FM. Pulmonary eosinophilic response to respiratory syncytial virus infection in mice sensitized to the major surface glycoprotein G. Int Immunol 1992;4:493-500.
    • (1992) Int Immunol , vol.4 , pp. 493-500
    • Openshaw, P.J.1    Clarke, S.L.2    Record, F.M.3
  • 28
    • 84871661160 scopus 로고    scopus 로고
    • Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine
    • Glenn GM, Smith G, Fries L, et al. Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine. Vaccine 2013;31:524-32.
    • (2013) Vaccine , vol.31 , pp. 524-532
    • Glenn, G.M.1    Smith, G.2    Fries, L.3
  • 29
    • 84858158220 scopus 로고    scopus 로고
    • Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children
    • Bernstein DI, Malkin E, Abughali N, 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;31:109-14.
    • (2012) Pediatr Infect Dis J , vol.31 , pp. 109-114
    • Bernstein, D.I.1    Malkin, E.2    Abughali, N.3
  • 30
    • 84878393878 scopus 로고    scopus 로고
    • 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
    • Yang CF, Wang CK, Malkin E, et al. 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 2013;31:2822-7.
    • (2013) Vaccine , vol.31 , pp. 2822-2827
    • Yang, C.F.1    Wang, C.K.2    Malkin, E.3
  • 31
    • 84894048036 scopus 로고    scopus 로고
    • Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age
    • Malkin E, Yogev R, Abughali N, 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.
    • (2013) PLoS ONE , vol.8 , pp. e77104
    • Malkin, E.1    Yogev, R.2    Abughali, N.3
  • 32
    • 20144370691 scopus 로고    scopus 로고
    • Identification of a recombinant live attenuated respiratory syncytial virus vaccine candidate that is highly attenuated in infants
    • Karron RA, Wright PF, Belshe RB, et al. Identification of a recombinant live attenuated respiratory syncytial virus vaccine candidate that is highly attenuated in infants. J Infect Dis 2005;191:1093-104.
    • (2005) J Infect Dis , vol.191 , pp. 1093-1104
    • Karron, R.A.1    Wright, P.F.2    Belshe, R.B.3
  • 33
    • 84882816956 scopus 로고    scopus 로고
    • Clinical development of Modified Vaccinia virus Ankara vaccines
    • Gilbert SC. Clinical development of Modified Vaccinia virus Ankara vaccines. Vaccine 2013;31:4241-6.
    • (2013) Vaccine , vol.31 , pp. 4241-4246
    • Gilbert, S.C.1
  • 35
    • 84875956814 scopus 로고    scopus 로고
    • Development of chimpanzee adenoviruses as vaccine vectors: Challenges and successes emerging from clinical trials
    • Capone S, D'Alise AM, Ammendola V, et al. Development of chimpanzee adenoviruses as vaccine vectors: challenges and successes emerging from clinical trials. Expert Rev Vaccines 2013;12:379-93.
    • (2013) Expert Rev Vaccines , vol.12 , pp. 379-393
    • Capone, S.1    D'Alise, A.M.2    Ammendola, V.3
  • 36
    • 84908876253 scopus 로고    scopus 로고
    • A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory
    • Swadling L, Capone S, Antrobus RD, et al. A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory. Sci Transl Med 2014;6:261ra153.
    • (2014) Sci Transl Med , vol.6 , pp. 261ra153
    • Swadling, L.1    Capone, S.2    Antrobus, R.D.3
  • 37
    • 84939434328 scopus 로고    scopus 로고
    • Efficacy of a virus-vectored vaccine against human and bovine respiratory syncytial virus infections
    • Taylor G, Thom M, Capone S, et al. Efficacy of a virus-vectored vaccine against human and bovine respiratory syncytial virus infections. Sci. Transl. Med. 7, 300ra127 (2015).
    • (2015) Sci. Transl. Med , vol.7 , pp. 300ra127
    • Taylor, G.1    Thom, M.2    Capone, S.3
  • 38
    • 84855372641 scopus 로고    scopus 로고
    • Vaccine vectors derived from a large collection of simian adenoviruses induce potent cellular immunity across multiple species
    • Colloca S, Barnes E, Folgori A, et al. Vaccine vectors derived from a large collection of simian adenoviruses induce potent cellular immunity across multiple species. Sci Transl Med 2012;4:115ra2.
    • (2012) Sci Transl Med , vol.4 , pp. 115ra2
    • Colloca, S.1    Barnes, E.2    Folgori, A.3
  • 39
    • 85015169841 scopus 로고    scopus 로고
    • Mucosal delivery of a vectored RSV vaccine is safe and elicits protective immunity in rodents and nonhuman primates
    • Pierantoni A, Esposito ML, Ammendola V, 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 2015;2:15018.
    • (2015) Mol Ther Methods Clin Dev , vol.2 , pp. 15018
    • Pierantoni, A.1    Esposito, M.L.2    Ammendola, V.3
  • 40
    • 84874918103 scopus 로고    scopus 로고
    • Vaccination to conserved influenza antigens in mice using a novel Simian adenovirus vector, PanAd3, derived from the bonobo Pan paniscus
    • Vitelli A, Quirion MR, Lo CY, et al. Vaccination to conserved influenza antigens in mice using a novel Simian adenovirus vector, PanAd3, derived from the bonobo Pan paniscus. PLoS ONE 2013;8: e55435.
    • (2013) PLoS ONE , vol.8 , pp. e55435
    • Vitelli, A.1    Quirion, M.R.2    Lo, C.Y.3
  • 41
    • 77953685708 scopus 로고    scopus 로고
    • CONSORT 2011 Statement: Updated guidelines for reporting parallel group randomised trials
    • Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:834-40.
    • (2011) J Clin Epidemiol , vol.63 , pp. 834-840
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3
  • 42
    • 13844318810 scopus 로고    scopus 로고
    • NHS health technology assessment programme a proposed charter for clinical trial data monitoring committees: Helping them to do their job well
    • Damocles Study Group
    • Damocles Study Group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711-22.
    • (2005) Lancet , vol.365 , pp. 711-722
  • 43
    • 0030841316 scopus 로고    scopus 로고
    • Priming with live respiratory syncytial virus (RSV) prevents the enhanced pulmonary inflammatory response seen after RSV challenge in BALB/c mice immunized with formalin-inactivated RSV
    • Waris ME, Tsou C, Erdman DD, et al. Priming with live respiratory syncytial virus (RSV) prevents the enhanced pulmonary inflammatory response seen after RSV challenge in BALB/c mice immunized with formalin-inactivated RSV. J Virol 1997;71:6935-9.
    • (1997) J Virol , vol.71 , pp. 6935-6939
    • Waris, M.E.1    Tsou, C.2    Erdman, D.D.3
  • 44
    • 38449084342 scopus 로고    scopus 로고
    • CD8T cells inhibit respiratory syncytial virus (RSV) vaccine-enhanced disease
    • Olson MR, Varga SM. CD8T cells inhibit respiratory syncytial virus (RSV) vaccine-enhanced disease. J Immunol 2007;179:5415-24.
    • (2007) J Immunol , vol.179 , pp. 5415-5424
    • Olson, M.R.1    Varga, S.M.2


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