Vaccination with V114, a 15-valent pneumococcal conjugate vaccine, resulted in similar markers of immunity against the 13 serotypes covered by Prevnar 13 (PCV13) with immune responses against 2 additional serotypes among children with sickle cell disease (SCD), according to the results of a phase 3 trial published in Blood Advances.
“These results support the use of V114 in the pediatric SCD population for protection against pneumococcal disease,” the authors wrote in their report.
Children with SCD are at an increased risk for pneumococcal disease. Currently, PCV13 is effective to vaccinate children with SCD against 13 pneumococcal serotypes. The aim of this study was to evaluate the safety and efficacy of V114, which targets the same 13 serotypes as PCV13, but also targets serotypes 22F and 33F.
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This double-blind, phase 3 trial randomly assigned 103 children aged 5 to 17 with SCD to receive vaccination with V114 or PCV13. The primary safety endpoint was evaluating the proportion of patients who developed adverse events (AEs). The primary and secondary immunogenicity endpoints were IgG GMCs and OPA GMTs 30 days after vaccination, respectively.
V114 and PCV13 resulted in similar markers of immune response against the 13 shared serotypes. Both the mean IgG geometric concentration (GMCs) and mean opsonophagocytic activity (OPA) geometric titers (GMTs) were similar between the groups. In addition, V114 induced a greater mean IgG GMCs and OPA GMTs against serotypes 22F and 33F compared with PCV13.
The safety profiles were similar between V114 and PCV13. Vaccine-related AEs occurred among 73.9% and 76.5% of patients in the V114 and PCV13 groups, respectively. There were no serious vaccine-related AEs or deaths in either group.
The rate of injection-site AEs was 69.6% in the V114 group and 76.5% in the PCV13 group. The most common injection-site reactions with V114 was mild pain and moderate swelling.
Systemic vaccine-related AEs occurred more frequently in the V114 group at 40.6% compared with 20.6% in the PCV13 group. The majority of systemic AEs with V114 were mild, with the most common being headache, myalgia, and fatigue.
The authors concluded that “These data suggest that V114 has a generally comparable safety, tolerability, and immunogenicity profile to PCV13 and further induces immunogenicity to serotypes 22F and 33F.”
Disclosures: This study was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Please see the original reference for a full list of disclosures.
Reference
Quinn CT, Wiedmann RT, Jarovsky D, et al. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study. Blood Adv. 2023;7:414-421. doi: 10.1182/bloodadvances.2022008037
