Lot-to-lot immunogenicity consistency of the respiratory syncytial virus prefusion F protein vaccine in older adults.

Background

Previous phase 3 studies showed that the AS01

Methods

This phase 3, multicenter, double-blind study randomized (1:1:1) participants ≥ 60 years of age to receive one of three RSVPreF3 OA lots. Serum RSVPreF3-binding immunoglobulin G (IgG) concentration was assessed at baseline and 30 days post-vaccination. Lot-to-lot consistency was demonstrated if the two-sided 95 % confidence intervals (CIs) of the RSVPreF3-binding IgG geometric mean concentration (GMC) ratios between each lot pair at 30 days post-vaccination were within 0.67 and 1.50. Solicited adverse events (AEs) within four days, unsolicited AEs within 30 days, and serious AEs (SAEs) and potential immune-mediated diseases within six months post-vaccination were recorded.

Results

A total of 757 participants received RSVPreF3 OA, of whom 708 were included in the per-protocol set (234, 237, and 237 participants for each lot). Lot-to-lot consistency was demonstrated: GMC ratios were 1.06 (95 % CI: 0.94-1.21), 0.92 (0.81-1.04), and 0.87 (0.77-0.99) between the lot pairs (lot 1/2; 1/3; 2/3). For the three lots, the RSVPreF3-binding IgG concentration increased 11.84-, 11.29-, and 12.46-fold post-vaccination compared to baseline. The reporting rates of solicited and unsolicited AEs, SAEs, and potential immune-mediated diseases were balanced between lots. Twenty-one participants reported SAEs; one of these-a case of atrial fibrillation-was considered by the investigator as vaccine-related. SAEs with a fatal outcome were reported for four participants, none of which were considered by the investigator as vaccine-related.

Conclusion

This study demonstrated lot-to-lot immunogenicity consistency of three RSVPreF3 OA vaccine lots and indicated that the vaccine had an acceptable safety profile.ClinicalTrials.gov: NCT05059301.

Informations de copyright

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Déclaration de conflit d'intérêts

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Alexander Murray (AM) reports a relationship with PharmQuest that includes: employment. AM reports that payments were made by GSK to his institution as clinical research trial site. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Aurelie Olivier (AO) reports a relationship with GSK that includes: employment and equity or stocks. Aurelie Olivier (AO) has patent pending to GSK. AO is an employee of GSK at the time the study was designed, initiated, and/or conducted. AO holds shares of stock in the company as part of their employee remuneration. AO is co-applicants on a pending patent filed by GSK. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Franck Maschino (FM) reports a relationship with GSK that includes: employment and equity or stocks. FM is an employee of GSK at the time the study was designed, initiated, and/or conducted. FM holds shares of stock in the company as part of their employee remuneration. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Johan Sanmartin Berglund (JSB) reports a relationship with Blekinge Institute of Technology that includes: employment. Johan Sanmartin Berglund (JSB) has nothing else to disclose. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Lew Pliamm (LP) reports a relationship with Canadian Phase Onward Inc. that includes: employment. LP has nothing else to disclose. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Lars Rombo (LR) reports a relationship with Clinical Research Centre Sörmland that includes: employment. LR reports that payment was made by GSK to his institution for conducting the study. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Murdo Ferguson (MF) reports a relationship with Colchester Research Group (CRG) that includes: employment. MF is employed by CRG which was contracted by GSK to execute the study. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Marie-Pierre David (M-PD) reports a relationship with GSK that includes: employment and equity or stocks. Marie-Pierre David (M-PD) has patent pending to GSK. M-PD is an employee of GSK at the time the study was designed, initiated, and/or conducted. M-PD holds shares of stock in the company as part of their employee remuneration. M-PD is co-applicants on a pending patent filed by GSK. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Nathalie De Schrevel (NDS) reports a relationship with GSK that includes: employment and equity or stocks. NDS is an employee of GSK at the time the study was designed, initiated, and/or conducted. NDS holds shares of stock in the company as part of their employee remuneration. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Shady Kotb (SK) reports a relationship with GSK that includes: employment and equity or stocks. SK is an employee of GSK at the time the study was designed, initiated, and/or conducted. SK holds shares of stock in the company as part of their employee remuneration. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. All authors reports financial support was provided by GlaxoSmithKline Biologicals SA. Veronica Hulstrom reports a relationship with GSK that includes: employment and equity or stocks. VH is an employee of GSK at the time the study was designed, initiated, and/or conducted. VH holds shares of stock in the company as part of their employee remuneration. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.