# 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

## TL;DR

A new pneumococcal vaccine, V116, was tested in adults at higher risk of pneumococcal disease and found to be safe and effective.

## Contribution

V116, a 21-valent pneumococcal conjugate vaccine, showed superior immune responses and tolerability compared to existing vaccines in high-risk adults.

## Key findings

- V116 elicited robust immune responses for all 21 serotypes it contains.
- OPA GMTs and IgG GMCs for V116 were comparable or better than PCV15 + PPSV23 for overlapping and unique serotypes.
- V116 was well tolerated with no vaccine-related serious adverse events or deaths.

## Abstract

Pneumococcal disease (PD) is a major cause of hospitalization and mortality in adults. Individuals with certain chronic illnesses are at increased risk for PD.

This 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.

V116 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.

V116 elicits robust immune responses and is well tolerated in adults 18–64 years of age with conditions associated with an increased risk of PD.

This article describes results of a phase 3 study assessing the safety, tolerability, and immunogenicity of 21-valent pneumococcal conjugate vaccine, V116, in adults at increased risk for pneumococcal disease. V116 was well tolerated and elicited robust immune responses.