A Candidate Respiratory Syncytial Virus (RSV) Prefusion F Protein Investigational Vaccine (RSVPreF3 OA) Is Immunogenic when Administered in Adults≥60 Years of Age: Results at 6 Months after Vaccination

Objectives Respiratory Syncytial Virus (RSV) infections are frequent and can lead to respiratory complications in older adults (OA). However, there is no licensed RSV vaccine yet. Here we present immunogenicity results up to month (M) 6 after vaccination with RSV Prefusion F Protein Investigational Vaccine (RSVPreF3 OA).

Methods In this phase 3 multi-country ongoing study (NCT04732871), adults≥60 years of age were randomized (3:1:1) to receive RSVPreF3 OA and followed up for 3 years. All participants received a dose of RSVPreF3 on day (D) 1. Humoral immune (HI) and cell-mediated immune (CMI) responses were measured in subsets of participants at pre-vaccination (D1), D31 and M6. HI outcomes included RSV-A and RSV-B neutralizing antibody (NAb) geometric mean titers (GMTs) and RSVPreF3-specific immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs). CMI response was assessed by frequency of RSVPreF3-specific CD4+T-cells and CD8+T-cells expressing at least 2 activation markers including at least 1 cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL-13, IL-17 (polypositive T-cells).

Results A total of 1653 participants received a dose of RSVPreF3 OA. Of these, 987 participants were included in the HI subset and 566 in the CMI subset at D1. The RSV-A and RSV-B GMTs and RSVPreF3-specific IgG GMCs increased between D1 and D31 followed by a decline until M6. At D31, RSV-A and RSV-B NAb GMTs were 10.5-fold and 7.8-fold higher than pre-vaccination ([Figure 1]), and RSVPreF3-specific IgG antibody GMCs was 12.2-fold higher than pre-vaccination levels. At M6, RSV-A and RSV-B GMTs were 4.4-fold and 3.5-fold, and RSVPreF3-specific IgG antibody GMCs 4.7-fold above pre-vaccination levels. RSVPreF3-specific polypositive CD4+T-cell median frequency (events/10⁶ cells) increased from 191 (below assay quantification limit) to 1339 at D31 and declined to 666 (above assay quantification limit) by M6. No RSVPreF3-specific CD8+T-cell response was detected after vaccination.

Fig. 1 CI, confidence interval; D, day; ED60, serum dilution inducing 60% inhibition in plaque-forming units; M, month; Nab, neutralizing Antibody; N, number of participants with available results.

Conclusions In adults≥60 years of age, 1 dose of RSVPreF3 OA was shown to be immunogenic, with both high HI and specific CMI responses at D31 post-vaccination remaining 3.5–4.7 fold above pre-vaccination levels at M6. Monitoring of immunogenicity will be continued up to 3 years.

Funding GlaxoSmithKline Biologicals SA.

Encore of IDWeek 2022.

Publication History

Article published online:
09 March 2023