Vaccine Institute, St. George's University of London & St George's University Hospital NHS Trust, London, UK.
United Kingdom Health Security Agency, Colindale, UK.
HIV Med. 2023 Sep;24(9):979-989. doi: 10.1111/hiv.13495. Epub 2023 Apr 23.
People living with HIV have been shown to have an increased risk of invasive meningococcal disease. In some countries, meningococcal vaccines are now routinely recommended to all people living with HIV, but no study has yet assessed the immunogenicity and safety of a meningococcal serogroup B vaccine or the co-administration of a MenB and MenACWY vaccine in people living with HIV.
This phase IV open-label clinical trial investigated the immunogenicity and safety of two doses of a four-component recombinant protein-based MenB vaccine (4CMenB) and a quadrivalent conjugate polysaccharide MenACWY vaccine (MenACWY-CRM197) given 1 month apart in a population of people living with HIV. Immunogenicity analysis was performed before vaccination and 1 month after the second doses of 4CMenB and MenACWY. Primary outcome measures were serum bactericidal assay geometric mean titres against three MenB reference strains at baseline and 1 month post vaccination, the proportion of participants achieving a putative protective titre of ≥4, and the proportion of participants with a ≥4-fold rise in titre from baseline. Secondary outcome measures were serum bactericidal assay geometric mean titres against MenA, C, W, and Y reference strains at baseline and 1 month post vaccination, the proportion achieving a putative protective titre of ≥8, and the proportion with a ≥4-fold rise in titre from baseline. Safety outcomes were solicited and unsolicited adverse events in the 7 days following vaccination. The trial was registered with clinicaltrials.gov (NCT03682939).
In total, 55 participants aged 20-45 years were enrolled. All participants (100%; 95% confidence interval [CI] 93-100) achieved putative protective titres for two of the three MenB strains and for MenA, W, and Y. A total of 98% (95% CI 89-100) achieved a protective titre for the third MenB strain and 94% (95% CI 83-99) for MenC. No serious adverse events were reported.
4CMenB and MenACWY were immunogenic and well-tolerated in a population of people living with HIV 1 month after two doses.
已有研究表明，HIV 感染者侵袭性脑膜炎球菌病的风险增加。在一些国家，脑膜炎球菌疫苗现在常规推荐给所有 HIV 感染者，但尚未有研究评估脑膜炎球菌 B 群疫苗或 MenB 和 MenACWY 联合疫苗在 HIV 感染者中的免疫原性和安全性。
本 IV 期开放标签临床试验在 HIV 感染者人群中研究了两剂四价重组蛋白基脑膜炎 B 群疫苗（4CMenB）和一剂四价结合多糖脑膜炎 A、C、W 和 Y 疫苗（MenACWY-CRM197）间隔 1 个月给药的免疫原性和安全性。免疫原性分析在接种前和接种 4CMenB 及 MenACWY 两剂后 1 个月进行。主要终点测量指标为接种前和接种后 1 个月对三种脑膜炎 B 群参考株的血清杀菌抗体几何平均滴度（GMT），达到假定保护滴度≥4 的参与者比例，以及接种前和接种后 1 个月 GMT 较基线升高≥4 倍的参与者比例。次要终点测量指标为接种前和接种后 1 个月对脑膜炎 A、C、W 和 Y 群参考株的血清杀菌抗体 GMT，达到假定保护滴度≥8 的参与者比例，以及接种前和接种后 1 个月 GMT 较基线升高≥4 倍的参与者比例。安全性结局为接种后 7 天内主动和被动报告的不良事件。该试验在 clinicaltrials.gov 注册（NCT03682939）。
共纳入 55 名 20-45 岁的参与者。所有参与者（100%；95%置信区间[CI] 93-100）对三种脑膜炎 B 群菌株中的两种以及对脑膜炎 A、W 和 Y 群均达到了假定的保护滴度。共有 98%（95%CI 89-100）的参与者对第三种脑膜炎 B 群菌株和 94%（95%CI 83-99）的脑膜炎 C 群达到了保护滴度。未报告严重不良事件。
4CMenB 和 MenACWY 在 HIV 感染者中两剂接种后 1 个月具有免疫原性且耐受性良好。
