Skip to main content
. 2020 Nov 11;8(4):672. doi: 10.3390/vaccines8040672

Table 6.

Overview of the anti-RSV monoclonal antibodies 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
Nirsevimab,
(MEDI-8897),
MedImmune
(AstraZeneca)		 Antibody
targeting site Ø of the F protein of RSV
(extended half-life obtained with YTE
mutation in Fc)		 I [126] Healthy adults IV or IM NCT02114268 April 2014–June 2015
(n = 136)		 Single dose of MEDI-8897 (n = 102) in 1 of 5 cohorts (300, 1000, 3000 mg iv or 100, 300 mg im) vs. placebo (n = 34), f.up for 360 days
  • -

    Mean half-life 85–117 days;

  • -

    similar ADA responses (mAb 13.7% vs. placebo 15.2%)
Ib/IIa [127] Healthy preterm infants IM NCT02290340 January 2015–September 2016
(n = 151)		 Published results on 89 healthy preterm infants,
single dose of MEDI-8897 (n = 71) in 1 of 3 cohorts (10, 25, 50 mg im) vs. placebo (n = 18), follow-up for 360 days,
  • -

    mean half-life 62.5–72.9 days;

  • -

    different ADA responses (mAb 26.5% vs. placebo 0%)
IIb [19] Healthy preterm infants IM NCT02878330 November 2016–November 2017
(n = 1453)		 Single dose of 50 mg im MEDI-8897 (n = 969) vs. placebo
(n = 484), follow-up for 360 days
  • -

    significantly lower RSV-LRTI incidence for MEDI-8897 vs. placebo (relative difference 70.1% (95% CI 52.3–81.2), p < 0.001);

  • -

    significantly lower RSV-LRTI hospitalization for MEDI-8897 vs. placebo (relative difference 78.4% (95% CI 51.9–90.3), p < 0.001)
III [128] Healthy late preterm and term infants
(born at or after 35 weeks GA, aged <1 year)		 NA (IM?) NCT03979313 July 2019–In progress
(estimated n = 3000)
  • -

    Results NA
II/III [129] High-risk children
(preterm infants born ≤35 weeks GA without CLD/CHD, infants with CLD of prematurity, hemodynamically significant CHD)		 NA (IM?) NCT03959488 July 2019–In progress (estimated n = 1500)
  • -

    Results NA
II [130] Immunocompromised Japanese children aged < 2 years IM NCT04484935 Not recruiting yet
  • -

    Results NA
MK-1654,
Merck Sharp and Dohme Corp.		 Antibody
targeting site IV of the F protein of RSV with an
extended half-life		 IIa [133] Healthy adults IV NCT04086472 October 2019–In progress
(n = 80)
  • -

    Results NA
I/II [134] Healthy pre-term (born at 29–35 weeks GA) and full-term (born at >35 weeks GA) infants IM NCT03524118 September 2018–In progress (estimated n = 180)
  • -

    Results NA