Merck said that V114, its investigational 15-valent pneumococcal conjugate vaccine candidate, has met safety and immunogenicity goals in two initial phase 3 trials in adults.
Both the late-stage trials – PNEU-WAY and PNEU-FLU evaluated the safety, tolerability, and immunogenicity of V114, said Merck. The investigational vaccine is being developed for the prevention of pneumococcal disease in adults and also children.
The PNEU-WAY study was held in 302 adults with Human Immunodeficiency Virus (HIV). The trial showed that the vaccine candidate evoked an immune response to all 15 serotypes contained in it, which included serotypes 22F and 33F.
According to Merck, the PNEU-WAY trial, the participants were randomly grouped in a 1:1 ratio to receive V114 or the presently available 13-valent pneumococcal conjugate vaccine (PCV13) followed by PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent).
Merck’s 15-valent pneumococcal conjugate vaccine candidate met its primary immunogenicity objective as measured by serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) and Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for all the serotypes contained in it at 30 days post-vaccination.
Furthermore, V114’s safety profile was generally comparable with PCV13.
On the other hand, data from the PNEU-FLU study held in healthy adults aged 50 years and above showed that V114 can be concomitantly given with the quadrivalent influenza vaccine. In this trial, participants in the concomitant arm were given V114 and the quadrivalent influenza vaccine (QIV) on Day 1 and received placebo nearly 30 days later at Visit 2.
Participants in the non-concomitant group were given placebo and QIV on Day 1 and received V114 nearly 30 days later at Visit 2. The study met its two primary immunogenicity objectives.
Merck’s investigational vaccine candidate given concomitantly with QIV was noninferior in comparison to the same when administered non-concomitantly with QIV. This was based on the serotype-specific OPA GMTs at 30 days post-vaccination with the investigational vaccine.
A total of 16 trials are studying V114’s safety, tolerability, and immunogenicity in various populations, who are prone to pneumococcal disease and also people who are immunocompromised or have certain chronic conditions.
Merck Research Laboratories vaccine clinical research executive director in biologics Luwy Musey said: “Certain populations are at greater risk for pneumococcal disease, reinforcing the importance of investigating new interventions focused on their specific needs.
“Results from these first two Phase 3 studies of V114 are encouraging and we look forward to sharing additional data in the future from our ongoing clinical development program, including our pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.”