Merck’s investigational pneumonia vaccine, V114, hit the mark in two Phase III studies, including one involving adult HIV patients.
V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, was assessed in two late-stage studies. The PNEU-WAY trial studied the vaccine in adults with HIV, as well as the PNEU-FLU program. In the PNEU-WAY study, V114 elicited an immune response to all 15 serotypes included in the vaccine, and in PNEU-FLU, the study showed V114 can be given concomitantly with the quadrivalent influenza vaccine. Results from these studies, as well as a study evaluating Pneumovax 23 (Pneumococcal Vaccine Polyvalent) were published in the online digital library of the International Symposium on Pneumococci and Pneumococcal Diseases.
Luwy Musey, executive director in biologics, vaccine clinical research at Merck Research Laboratories, said the results of the two Phase III studies are encouraging. He said the company plans to share additional data from the other ongoing 14 V114 programs in the future. Those programs include pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.
During a virtual press briefing on the results, Musey said he looks forward to seeing how the vaccine candidate can positively impact this disease worldwide.
The V114 clinical development program includes 16 trials investigating the safety, tolerability and immunogenicity of V114 in a number of populations who are at increased risk for pneumococcal disease including both healthy older adult and healthy pediatric populations. The studies also include people who are immunocompromised or have certain chronic conditions.
In the PNEU-WAY study, Merck studied the use of V114 followed by Pneumovax 23 in HIV patients compared to the currently available 13-valent pneumococcal conjugate vaccine and Pneumovax 23. Merck said V114 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 15 serotypes contained in the vaccine 30 days after administration. The OPA GMTs and IgG GMCs for the 13 shared serotypes between V114 and PCV13 were generally comparable between the two groups, but, immune responses were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114, 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide, Merck said.
In the PNEU-FLU study, patients were randomized to receive either V114 and the quadrivalent influenza vaccine (QIV) or placebo combined with the quadrivalent influenza vaccine. Merck said the study met both primary immunogenicity objectives. V114 was noninferior based on serotype-specific OPA GMTs at 30 days post-vaccination. Additionally, QIV administered concomitantly with V114 was noninferior to QIV administered non-concomitantly with V114, based on the influenza strain-specific hemagglutination inhibition (HAI) GMTs at 30 days post-vaccination with QIV, Merck said.
