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

Table 3.

Overview of the RSV vector-based vaccines in 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
MVA-BN RSV, BavarianNordic F, G (A and B subtypes), N, M2 I [45] Healthy adults and older adults (50–65 years) IM NCT02419391 August 2015–May 2016
(n = 63)
  • -

    Well tolerated and immunogenic;

  • -

    Higher and broader cellular and humoral immune responses in the high dose group (1 × 108 TCID50) compared to low dose group (1 × 107 TCID50)

II [46] Older adults
(≥55 years)
IM NCT02873286 September 2016–August 2018
(n = 420)
  • -

    Well tolerated with no vaccine-related SAEs;

  • -

    A single vaccination with the high dose (1 × 108 TCID50) induced a broad Ab (neutralizing Ab and total IgG and IgA titres) and Th1-biased cellular immune response against all 5 RSV antigens;

  • -

    The immune response persisted at least 6 months and can be boosted at 12 months.

PanAd3-RSV and MVA-RSV, ReiThera F, N and M2 I [48,49] Healthy adults and older adults (60–75 years) IM (PadAd3 and MVA);
IN (PanAd3)
NCT01805921 March 2013–August 2015
(n = 72: 42 healthy adults + 30 older adults)
  • -

    Well tolerated and immunogenic;

  • -

    RSV neutralising Ab titres increased after IM prime with PanAd3-RSV and after IM boost for vaccinees primed by the IN route;

  • -

    Anti-F IgG and IgA Ab secreting cells increased after IM PanAd3-RSV prime and after IM MVA-RSV boost;

  • -

    PanAd3-RSV prime/MVA-RSV boost induced robust RSV specific T-cell responses independent of the route of priming in adults;

  • -

    RSV-specific T-cell immune responses was most marked in older adults following IM prime.

VXA-RSVf, Vaxart F, dsDNA activating TLR3 receptor I [51] Healthy adults ORAL NCT02830932 June 2016–September 2017
(n = 66)
  • -

    Results NA

Ad26.RSV.Pre-F, Janssen Prefusion F I [67] Healthy elderly
(≥60 years)
IM NCT02926430 November 2016–January 2019
(n = 73)
  • -

    Results NA

II [53] Healthy elderly
(≥60 years)
IM NCT03339713 December 2017–July 2018
(n = 180)
  • -

    The co-administration of Ad26.RSV.preF with a seasonal influenza vaccine was well tolerated and showed no evidence of interference in immune response

II [54] Healthy elderly
(≥65 years)
IM NCT03982199 August 2019–In progress
(estimated n = 6672)
  • -

    Results NA

I/IIa [56] Adults and
RSV-seropositive children
(12–24 months)
IM NCT03303625 November 2017–April 2020
(n = 48)
  • -

    Results NA

I/IIa [57] RSV-seronegative children
(12–24 months)
IM NCT03606512 January 2019–In progress
(estimated n = 38)
  • -

    Results NA

I [68] Healthy adults, older adults IM NCT03795441 January 2019–July 2019
(n = 24)
  • -

    Results NA

II [69] Healthy adults IM NCT03334695 October 2016–November 2018 (n = 64)
  • -

    Results NA

Ad26.RSV.Pre-F +/− prefusion F, Jannsen Purified Prefusion F II [55] Healthy elderly
(≥60 years)
IM NCT03502707 July 2018–In progress
(estimated n = 669)
  • -

    Results NA

ChAd155-RSV, GlaxoSmithKline F, N, M2-1 I [58] RSV-seropositive adults IM NCT02491463 July 2015–February 2017
(n = 73)
  • -

    Well tolerated and safe;

  • -

    ChAD155-RSV induced specific humoral and cellular immune response

II [59] RSV-seropositive infants
(12–23 months)
IM NCT02927873 January 2017–In progress
(estimated n = 82)
  • -

    Results NA

I [60] Likely RSV-seronegative infants
(6–7 months)
IM NCT03636906 April 2019–In progress
(estimated n = 201)
  • -

    Results NA

MEDI-534, MedImmune Wild type F I [62] RSV/PIV3-seropositive children (1–9 years) IN NCT00345670 June 2006–May 2007
(n = 120)
  • -

    Acceptable safety profile;

  • -

    Minimally immunogenic

I [63] RSV/PIV3-seronegative children (6–24 months) and infants (2 months) IN NCT00686075 June 2008–August 2012
(n = 1338)
  • -

    Published results on 49 healthy children (6–24 months);

  • -

    Well tolerated and safe;

  • -

    Seroresponse to RSV and PIV3 highest in high dose (1 × 106 TCID50) group

SeVRSV, NIAID Wild type F I [66] Healthy adults IN NCT03473002 May 2018–February 2019
(n = 21)
  • -

    Results NA