ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05696080 (A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.), which is not on this map. Cited by 3 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.
Who cites it
3 citing papers in PubMed.
- A phase 3, randomized study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk of pneumococcal disease (STRIDE-13).Human vaccines & immunotherapeutics · 2026Trial
- Vaccination in systemic lupus erythematosus.Human vaccines & immunotherapeutics · 2026Review
- Impact of Vaccines Across the Lifespan: A New Perspective in Public Health-Conclusions of an Expert Panel-Part 2.Vaccines · 2026Review
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPneumococcal disease (PD) is a major cause of hospitalization and mortality in adults. Individuals with certain chronic illnesses are at increased risk for PD.
methodsThis phase 3, randomized, double-blind, active comparator-controlled trial (NCT05696080) evaluated the safety and immunogenicity of 21-valent pneumococcal conjugate vaccine (V116) in adults 18-64 years of age with ≥1 condition associated with increased risk of PD (diabetes mellitus or kidney, heart, liver, or lung disease). Participants were given a single dose of either V116 followed by placebo or 15-valent pneumococcal conjugate vaccine (PCV15), followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later. Immune responses were evaluated by opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days postvaccination (day 30 for V116; week 12 for PCV15 + PPSV23). Proportions of participants who experienced adverse events (AEs) within 5 days postvaccination and serious AEs (SAEs) or deaths during the study were assessed.
resultsV116 was immunogenic for all 21 serotypes contained in the vaccine. OPA GMTs and IgG GMCs following V116 vaccination were comparable to PCV15 + PPSV23 for the 13 serotypes common between vaccine groups. For the eight serotypes unique to V116, immune responses were higher following V116 compared with PCV15 + PPSV23. V116 was well tolerated compared with PCV15 + PPSV23; no vaccine-related SAEs or deaths were reported.
conclusionsV116 elicits robust immune responses and is well tolerated in adults 18-64 years of age with conditions associated with an increased risk of PD.
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