Merck & Co., Inc., Rahway, New Jersey, USA.
Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa.
AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17.
To evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV.
This phase 3 study (NCT03921424) randomized participants 6-17 years of age with HIV (CD4 + T-cell count ≥200 cells/μl, plasma HIV RNA <50 000 copies/ml) to receive V114 or 13-valent PCV (PCV13) in a double-blind manner on Day 1, followed by PPSV23 at Week 8.
Adverse events (AEs), pneumococcal serotype-specific immunoglobulin G (IgG), and opsonophagocytic activity (OPA) were evaluated 30 days after each vaccination.
The proportion of participants experiencing at least one AE post-PCV was 78.8% in the V114 group ( n = 203) and 69.6% in the PCV13 group ( n = 204); respective proportions post-PPSV23 were 75.4% ( n = 203) and 77.2% ( n = 202). There were no vaccine-related serious AEs. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) were generally comparable between V114 and PCV13 for shared serotypes at Day 30, and were higher for V114 compared with PCV13 for the additional V114 serotypes 22F and 33F. Approximately 30 days after PPSV23, IgG GMCs and OPA GMTs were generally comparable between the V114 and PCV13 groups for all 15 serotypes in V114.
In children with HIV, a sequential administration of V114 followed 8 weeks later with PPSV23 is well tolerated and induces immune responses for all 15 pneumococcal serotypes included in V114.
评估 V114（含血清型 1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、22F、23F、33F 的 15 价肺炎球菌结合疫苗）接种后 8 周再接种 23 价肺炎球菌多糖疫苗（PPSV23）的安全性和免疫原性，该研究纳入了 HIV 感染儿童。
这是一项 3 期研究（NCT03921424），参与者为 6-17 岁的 HIV 感染儿童（CD4+T 细胞计数≥200 个/μl，血浆 HIV RNA＜50 000 拷贝/ml），他们被随机分配到 V114 或 13 价肺炎球菌结合疫苗（PCV13）组，两组均在第 1 天接受双盲接种，然后在第 8 周接种 PPSV23。
接种后 30 天评估不良事件（AE）、肺炎球菌血清型特异性免疫球蛋白 G（IgG）和调理吞噬活性（OPA）。
V114 组（n=203）和 PCV13 组（n=204）在接种 PCV 后至少出现 1 例 AE 的参与者比例分别为 78.8%和 69.6%；在接种 PPSV23 后这一比例分别为 75.4%（n=203）和 77.2%（n=202）。两组均未出现与疫苗相关的严重 AE。在接种第 30 天，V114 和 PCV13 组之间的 IgG 几何平均浓度（GMC）和 OPA 几何平均滴度（GMT）对于共有血清型一般相当，V114 对额外的 V114 血清型 22F 和 33F 的 IgG GMC 和 OPA GMT 高于 PCV13。大约在接种 PPSV23 后 30 天，V114 组的 IgG GMC 和 OPA GMT 对于 V114 中的所有 15 个血清型在两组间通常相当。
在 HIV 感染儿童中，序贯接种 V114 后 8 周再接种 PPSV23 耐受性良好，可诱导对 V114 所含所有 15 个肺炎球菌血清型的免疫应答。
