Immunogenicity and safety of two respiratory syncytial virus vaccine strategies in lung and allogeneic haematopoietic stem cell transplant recipients: A phase 2 trial RSVaxID

allogeneic haematopoietic stem cell transplant recipient, lung transplant

Proportion of participants in each group who achieve a seroresponse one month after completion of vaccination (V2). A seroresponse is defined as either (1) seroconversion or (2) a ≥4-fold rise in RSVpreF-binding serum IgG concentration from baseline, as measured by enzyme immunoassay (EIA).

RSV-A and RSV-B serum 50% neutralizing geometric mean titres (GMT) and corresponding neutralizing titre geometric mean fold rises (GMFR), measured by an RSV neutralization assay [time frame: baseline (visit 1), one month after completing vaccination (V2)]., Geometric mean concentrations (GMC) and corresponding geometric mean fold rises (GMFR) of RSVpreF-binding serum IgG, measured by standard EIA; proportion of participants in each group achieving a ≥2-fold rise in RSVpreF-binding serum IgG between baseline and visit 2, as measured by standard EIA; Log (serum dilution) for 50% signal inhibition in D25- and palivizumab-competitive EIA [time frame: baseline, pre-dose-2 (only arm B, visit 1b), v2 and one-year after first vaccine dose (v3), Descriptive: frequency, type and severity of local and systemic solicited adverse events within 7 days following each vaccine administration; frequency, type and severity of unsolicited adverse events within 30 days following each vaccine administration; severe adverse events and adverse events of special interest until the end of study, Geometric mean titres (GMT) and corresponding geometric mean fold rises (GMFR) of RSVpreF-binding oral fluid IgA, measured by EIA in oral fluid [time frame: baseline, visit 2], Analysis of determinants of humoral immunogenicity: [Time frame: baseline, V1b, V2, V3] age, time from transplantation, acute rejection episode(s) before and during the study period, type of induction immunosuppression, ongoing immunosuppressive treatment at the time of vaccination (in LTR); age, time from transplantation, stem cell source, type of donor, acute/chronic GVHD before and during the study period, ongoing immunosuppressive treatment at the time of vaccination (in HSCTR), Descriptive: frequency and severity (overall survival, need for hospitalization, ICU hospitalization, type of treatment, respiratory deterioration [in LTR only] until the end of study) of RT-PCR confirmed, medically attended RSV infection episodes, Full-length genome sequencing and sequence analysis of any clinical RSV isolate, Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA in vaccinated participants with medically attended RSV infection [Time frame: at the time of medically attended RSV infection], Geometric mean concentrations (GMC) of RSVpreF-binding serum IgG, geometric mean titres (GMT) of RSV-A/RSV-B serum neutralizing antibodies (NAbs) and GMT of RSVpreF-binding oral fluid IgA in participants with medically attended RSV infection and matched participants without medically attended RSV infection episodes [Time frame: baseline, visit 2]

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