STRIDE-8 (NCT05696080), a phase 3, double-blind, randomised (3:1) trial comparing V116 with PCV15 (administered Day 1) followed by PPSV23 (administered Week 8). Participants were adults aged 18-64 years with underlying chronic medical conditions and no prior pneumococcal vaccination. Outcomes included immunogenicity (opsonophagocytic activity (OPA) mean geometric titres (GMT) at Day 30 for V116 and Week 12 for PCV15 plus PPSV23) and safety. Overall, 516 adults were enrolled: 386 received V116 and 130 PCV15 on Day 1.
V116 demonstrated immunogenicity against all 21 serotypes included in the vaccine. OPA GMTs showed comparable responses to the PCV15 plus PPSV23 for common serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F) and higher responses for the serotypes unique to V116 (15A, 15C, 16F, 23A, 23B, 24F, 31, 35B). The safety profile of V116 was favourable, with lower rates of overall adverse events (68.7% vs 90.8%), including fewer local reactions (injection-site pain, erythema, swelling) and systemic reactions.
The authors concluded that V116 had a favourable safety profile versus PCV15 plus PPSV23 in vaccine-naïve participants aged 18-64 years with underlying chronic medical conditions. Immunogenicity was confirmed for all 21 serotypes, showing comparable protection against shared serotypes and enhanced responses for the 8 unique serotypes.
- Scott P, et al. A phase 3, randomised trial investigating the safety, tolerability, and immunogenicity of V116, an adult-specific pneumococcal conjugate vaccine, in adults with increased risk for pneumococcal disease (STRIDE-8). 6th ESCMID Conference on Vaccines, 10–13 September 2025, Lisbon, Portugal.
Medical writing support was provided by Mihai Surducan, PhD.
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