Assistance Publique-Hopitaux de Paris (AP-HP), Henri Mondor Hospital, Haematology Department, Creteil, France; University Paris-Est-Créteil, Créteil, France.
Assistance Publique-Hopitaux de Paris (AP-HP), Henri Mondor Hospital, Haematology Department, Creteil, France.
Clin Microbiol Infect. 2022 Dec;28(12):1609-1614. doi: 10.1016/j.cmi.2022.06.024. Epub 2022 Jul 5.
Despite a high risk of invasive meningococcal (Men) disease, there is no published data on any MenB vaccine after hematopoietic cell transplantation (HCT). We investigated the immunogenicity and safety of the 4CMenB recombinant vaccine (Bexsero) in adult HCT recipients.
Patients were eligible from 6 months post-HCT to receive 2 4CMenB doses at 2-month intervals. Sera were collected at baseline, 1 month after the second dose, and 12 months after enrolment. The serum bactericidal activity (SBA) using human complement (hSBA) was assessed against fHbp, NadA, PorAP1.4, and NHBA antigens. The vaccine response was defined by one criterion for one vaccine antigen: (1) in patients with a hSBA titer <4 at baseline: a titer ≥4; (2) in patients with a hSBA titer ≥4 at baseline: at least a 4 time increase.
Forty (40) patients were included at a median of 2.14 (0.57-13.03) years posttransplant. At baseline, most patients (32/40, 80%) had hSBA titers <4 for all vaccine antigens. After 2 vaccine doses, the proportion of patients with a titer ≥4 was significantly increased for fHbp (23/40, 57.5%), NadA (25/40, 62.5%), and PorA (31/40, 77.5%) but not for NHBA for which only 6 of 40 (15%) patients responded. Of patients, 36 out of 0 (90%) were responders to ≥1 antigen. However, 9 months later, only 23 out of 37 (62.2%) patients were still seroprotected. No severe adverse event was observed.
The response rate of 90% for ≥1 vaccine antigen and our safety data supports the 4CMenB vaccination of HCT recipients from 6 months after transplant with 2 doses.
尽管侵袭性脑膜炎奈瑟菌（Men）病的风险很高，但造血细胞移植（HCT）后尚无任何 MenB 疫苗的发表数据。我们研究了 4CMenB 重组疫苗（Bexsero）在成年 HCT 受者中的免疫原性和安全性。
从 HCT 后 6 个月起，患者符合条件可接受 2 剂 4CMenB，间隔 2 个月。在基线、第二剂后 1 个月和入组后 12 个月采集血清。使用人补体（hSBA）评估针对 fHbp、NadA、PorAP1.4 和 NHBA 抗原的血清杀菌活性（SBA）。疫苗反应通过针对一种疫苗抗原的一个标准来定义：（1）在基线 hSBA 滴度<4 的患者中：滴度≥4；（2）在基线 hSBA 滴度≥4 的患者中：至少增加 4 倍。
40 例（40 例）患者在移植后中位数为 2.14 岁（0.57-13.03 岁）时纳入研究。基线时，大多数患者（32/40，80%）对所有疫苗抗原的 hSBA 滴度<4。在接受 2 剂疫苗后，fHbp（23/40，57.5%）、NadA（25/40，62.5%）和 PorA（31/40，77.5%）的 hSBA 滴度≥4 的患者比例显著增加，但针对 NHBA 的患者仅 40 例中有 6 例（15%）有反应。40 例患者中，有 36 例（90%）对≥1 种抗原有反应。然而，9 个月后，仅有 37 例中的 23 例（62.2%）仍具有血清保护作用。未观察到严重不良事件。
≥1 种疫苗抗原的反应率为 90%，我们的安全性数据支持 HCT 后 6 个月的患者接受 2 剂 4CMenB 疫苗接种。
