Abstract
Background
V116, an investigational 21-valent PCV, contains the following pneumococcal polysaccharides (PnPs): 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B, and a de-O-acetylated 15B (deOAc15B). This phase 1 study evaluated the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naive adults compared with the 23-valent polysaccharide pneumococcal vaccine (PPSV23).
Methods
Adults (n=90) 18–49 years were randomized 1:1:1 to receive a single dose of V116-1 (2 μg dose/each PnPS, V116-2 (4 μg dose/PnPS) or PPSV23. Adverse events (AEs) were collected following vaccination. Pneumococcal serotype-specific opsonophagocytic activity (OPA) was measured prior to and 30 days postvaccination (Day 30).
Results
There were no serious AEs, deaths, or discontinuations due to AEs. Immune responses at Day 30 in the V116-1 and V116-2 groups were generally comparable to PPSV23 for the common serotypes and higher than PPSV23 for the unique serotypes. At Day 30, the OPA GMTs were higher in the V116-2 group compared with the V116-1 group for all serotypes except 9N. The OPA geometric mean titre ratio (95% CI) (V116-2/PPSV23) ranged from 0.89 (0.58, 3.51) to 2.40 (1.24, 4.62) for all common serotypes and 2.80 (1.64, 4.79) to 58.07 (25.10, 134.33) for all unique serotypes; the lower bound of the 95% CI for the OPA GMT ratio (V116-2/PPSV23) was >0.5 for all common serotypes and >1.0 for all unique serotypes.
Conclusions
These safety and immunogenicity data support the continued development of V116 for the prevention of pneumococcal disease in adults.