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. 2020 Nov 11;8(4):672. doi: 10.3390/vaccines8040672

Table 2.

Overview of the RSV particle-based vaccines under clinical development. Ab: antibody; ADA: anti-drug antibody; AE: adverse event; Ag: antigen; CI: confidence interval; CHD: congenital heart defect, CLD: chronic lung disease; COPD: chronic obstructive pulmonary disease; Corp: corporation; f.up: follow-up; GA: gestational age; IM: intramuscular; IN: intranasal; IV: intravenous; LRTD: lower respiratory tract disease; LRTI: lower respiratory tract infection; mAb: monoclonal antibody; NA: not available; NIAID: National Institute of Allergy and Infectious Diseases; PCA: palivizumab-competing antibody; PIV3: Parainfluenza Virus type 3; Ref: reference; RSV: respiratory Syncytial Virus; RT-PCR: reverse transcriptase polymerase chain reaction; SAE: serious adverse event; TCID50: Tissue Culture Infectious Dose 50%; vs.: versus.

Vaccine Name, Sponsor Antigen or Target Site Phase, Ref. Study Population Route Study ID Enrolment Time and Cohort Summary of Published Results
ResVax, Novavax Recombinant F protein exhibiting post-F morphology, with or without an aluminium phosphate adjuvant I [40] Women of childbearing age IM NCT01290419 December 2010–December 2011
(n = 150)
  • -

    Well tolerated, no dose-related increases in SAEs;

  • -

    Anti-RSV F IgG titres and PCA induced at levels that is reported to be associated with decreased risk of hospitalization
II [27] Women of childbearing age IM NCT01704365 October 2012–May 2013
(n = 330)
  • -

    Well tolerated and immunogenic;

  • -

    Most robust Ab response in 2-doses (60 or 90 µg) adjuvanted regimens;

  • -

    Reduced RSV infection in recipients (11% vs. 21%, p = 0.04)
II [28] Women of childbearing age IM NCT01960686 October 2013–April 2014
(n = 720)
  • -

    Well tolerated and immunogenic;

  • -

    Most robust Ab response with 120 μg and 0.4 mg aluminium formulation;

  • -

    RSV infection was reduced by 52% in vaccines (p = 0.009)
Recombinant F protein exhibiting post-F morphology, with an aluminium phosphate adjuvant II [31] Third-trimester pregnant women IM NCT02247726 September 2014–July 2016
(n = 50)
  • -

    Well tolerated and immunogenic;

  • -

    Transplacental antibody transfer was 90–120% across assays for infants of vaccinated women and it was higher in women with an interval of more than 30 days between vaccination and delivery
III [32] Pregnant women
(28–36 weeks of GA)		 IM NCT02624947 December 2015–June 2020
(n = 4636)		 Vaccine efficacy:
  • -

    39.4% in reducing RSV-specific medically significant LRTI in young infants (<3 months of age);

  • -

    58.8% efficacy in reducing RSV-related severe hypoxemia in young infants;

  • -

    44% efficacy in reducing RSV-LRTI hospitalization
RSV F nanoparticle, Novavax Recombinant F protein exhibiting post-F morphology +/− an aluminium phosphate adjuvant I [29] Elderly IM NCT01709019 October 2012–March 2014
(n = 220)
  • -

    Acceptable safety profile, no vaccine-related AEs;

  • -

    Most robust immune response in adjuvanted formulations compared to high dose (90 μg vs. 60 μg RSV F protein)
Recombinant F protein exhibiting post-F morphology without an adjuvant II [41] Elderly IM NCT02266628 October 2014–March 2016
(n = 1599)
  • -

    Results NA yet
II [42] Elderly IM NCT02593071 October 2015–November 2016
(n = 1330)
  • -

    Results NA yet
III [34] Elderly IM NCT02608502 November 2015–December 2016
(n = 11850)		 One dose of vaccine (135 µg RSV F protein) efficacy:
  • -

    No efficacy vs. RSV-symptomatic respiratory diseases and RSV-positive moderate-severe LRTI;

  • -

    61% reduction in hospitalizations due to COPD exacerbations
Recombinant F protein exhibiting post-F morphology, adjuvant: aluminium phosphate/Matrix M II [35] Elderly IM NCT03026348 January 2017–July 2018
(n = 1329)
  • -

    Both adjuvants increased the magnitude, duration and quality of the immune response versus non-adjuvanted RSV F vaccine
Recombinant F protein exhibiting post-F morphology, with or without an aluminium phosphate adjuvant I [30] Children
(2–6 years old)		 IM NCT02296463 November 2014–April 2016
(n = 32)
  • -

    Well tolerated;

  • -

    Anti-F IgG and PCA titres increase day 14, peak day 28, elevated to day 56;

  • -

    10-times increase PCA and anti-F IgG titres in adjuvanted group; 6-times increase in unadjuvanted group
SynGEM, Mucosis Prefusion F I [37] Healthy adults IN NCT02958540 Unknown
(n = 48)
  • -

    Well tolerated;

  • -

    PCA titres achieved plateau after the first dose in high-dose (250 μg) recipients; after a boost at day 28 in low-dose (140 μg) recipients;

  • -

    F protein site ∅-specific Ab were not detected