Vaccine · 2026
Phase 2 trial to evaluate the safety and immunogenicity of a 25-valent pneumococcal conjugate vaccine (IVT-PCV25) in infants.
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Bravo Lulu, Bermal Nancy, Alberto Edison, Pardo January Anne, Maronilla Maria Angela, Tanteo Maria Christine Joy, Clemens Sue Ann, Rockhold Frank W, Andi-Lolo Indah, Vilms Rohan J, Tasker Sybil A, Clemens Ralf L, Kapre Subhash, Borkowski Astrid
Аннотация
INTRODUCTION: IVT-PCV25 is a 25-valent pneumococcal conjugate vaccine designed to broaden serotype coverage beyond current vaccines. We evaluated the safety and immunogenicity in infants of three dose-ranging formulations of IVT-PCV25 in comparison to licensed Prevnar-20.
METHODS: In this double-blind phase 2 trial in the Philippines, 421 healthy infants were randomly assigned (1:1:1:1) to three IVT-PCV25-formulation arms or a Prevnar-20 arm. Three doses were administered 4-weeks apart from 6 weeks of age, alongside routine vaccinations. Adverse events (AEs), and IgG and functional antibody (opsonophagocytic; OPA) titres were assessed up to 28-days after Dose 3. Unlike IgG concentrations, OPA titres were only measured in a third of the population.
RESULTS: Solicited local and systemic AEs were reported for 90-93% and 94-99% of IVT-PCV25 recipients, respectively, and for 84% and 97% of Prevnar-20 recipients, respectively. These AEs were predominantly mild or moderate, and transient. No serious AE was attributed to IVT-PCV25. All formulations of IVT-PCV25 appeared immunogenic by IgG assay or OPA, or both. IgG GMTs to 19/25 serotype antigens were above the aggregate correlate-of-protection threshold of 0.35 μg/mL; and for the other 6/25 serotypes, the OPA GMTs were > 50-fold the lower limit of quantification (8 dil-1). No clear dose effect was observed. A 2-fold change in antigen quantity only led to a corresponding 2-fold antibody response for four serotypes, and by OPA only. In Prevnar-20 recipients, IgG GMCs were ≥ 0.85 μg/mL for all shared serotypes.
CONCLUSIONS: In infants, IVT-PCV25 had an acceptable safety profile. Although the results suggest that IVT-PCV25 has the potential to broaden serotype coverage, there is scope for formulation optimisation by rebalancing serotype-antigen quantities.
METHODS: In this double-blind phase 2 trial in the Philippines, 421 healthy infants were randomly assigned (1:1:1:1) to three IVT-PCV25-formulation arms or a Prevnar-20 arm. Three doses were administered 4-weeks apart from 6 weeks of age, alongside routine vaccinations. Adverse events (AEs), and IgG and functional antibody (opsonophagocytic; OPA) titres were assessed up to 28-days after Dose 3. Unlike IgG concentrations, OPA titres were only measured in a third of the population.
RESULTS: Solicited local and systemic AEs were reported for 90-93% and 94-99% of IVT-PCV25 recipients, respectively, and for 84% and 97% of Prevnar-20 recipients, respectively. These AEs were predominantly mild or moderate, and transient. No serious AE was attributed to IVT-PCV25. All formulations of IVT-PCV25 appeared immunogenic by IgG assay or OPA, or both. IgG GMTs to 19/25 serotype antigens were above the aggregate correlate-of-protection threshold of 0.35 μg/mL; and for the other 6/25 serotypes, the OPA GMTs were > 50-fold the lower limit of quantification (8 dil-1). No clear dose effect was observed. A 2-fold change in antigen quantity only led to a corresponding 2-fold antibody response for four serotypes, and by OPA only. In Prevnar-20 recipients, IgG GMCs were ≥ 0.85 μg/mL for all shared serotypes.
CONCLUSIONS: In infants, IVT-PCV25 had an acceptable safety profile. Although the results suggest that IVT-PCV25 has the potential to broaden serotype coverage, there is scope for formulation optimisation by rebalancing serotype-antigen quantities.