Pediatric, Adolescent, and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
Pediatr Infect Dis J. 2012 Jan;31(1):47-52. doi: 10.1097/INF.0b013e318236c67b.
Human immunodeficiency virus (HIV)-infected children are at increased risk of meningococcal infection and poor response to quadrivalent meningococcal conjugate vaccine (MCV4), but MCV4 has not been studied in preadolescent HIV-infected children.
The P1065 trial enrolled 2- to 10-year-old HIV-infected children with CD4 ≥ 25% to receive MCV4 at entry and at week 24. Rates of response (≥ 4-fold increase in rabbit serum bactericidal antibody) against each meningococcal serogroup (A, C, Y, W-135), geometric mean titers, and rates of seroprotection (rabbit serum bactericidal antibody titer ≥ 1:128) were determined from sera obtained at entry and weeks 4, 24, 28, and 72. Adverse events were assessed for 6 weeks after each MCV4 dose.
At entry, 47% of the 59 participants were male, 56% black, 31% Latino, median age was 6 years, 88% were receiving antiretroviral therapy, and 75% had viral load <400 copies/mL. There were no serious adverse events within 6 weeks after MCV4 doses; all vaccination reactions were mild. Response after a single MCV4 dose was high to serogroup A (92%) and W-135 (98%); responses improved after a second dose for serogroup C (43%-80%) (P < 0.0001) and Y (76%-84%) (P = 0.38). By week 72, seroprotection rates were 93%, 91%, 78%, and 46% for serogroups W-135, Y, A, and C, respectively.
Two doses of MCV4 were safe and immunogenic in 2- to 10-year-old HIV-infected children. The second dose increased the proportion of children who made a response to serogroup C. Seroprotection waned substantially for serogroups A and C within 1 year of last MCV4 dose.
感染人类免疫缺陷病毒（HIV）的儿童感染脑膜炎球菌的风险增加，并且对四价脑膜炎球菌结合疫苗（MCV4）的反应不佳，但尚未在青春期前感染 HIV 的儿童中研究 MCV4。
P1065 试验招募了 2 至 10 岁的 HIV 感染儿童，CD4 百分比≥25%，在入组时和第 24 周接受 MCV4 接种。从入组时和第 4、24、28 和 72 周采集的血清中确定针对每种脑膜炎球菌血清型（A、C、Y、W-135）的反应率（兔血清杀菌抗体增加≥4 倍）、几何平均滴度和血清保护率（兔血清杀菌抗体滴度≥1:128）。在每次 MCV4 剂量后 6 周评估不良事件。
在入组时，59 名参与者中 47%为男性，56%为黑人，31%为拉丁裔，中位年龄为 6 岁，88%正在接受抗逆转录病毒治疗，75%的病毒载量<400 拷贝/ml。MCV4 剂量后 6 周内无严重不良事件；所有疫苗接种反应均为轻度。单次 MCV4 剂量后的反应对血清 A（92%）和 W-135（98%）较高；第二次剂量后，血清 C（43%-80%）（P<0.0001）和 Y（76%-84%）（P=0.38）的反应得到改善。到第 72 周，血清保护率分别为血清型 W-135、Y、A 和 C 的 93%、91%、78%和 46%。
在 2 至 10 岁的 HIV 感染儿童中，两剂 MCV4 既安全又具有免疫原性。第二次剂量增加了对血清型 C 产生反应的儿童比例。在最后一次 MCV4 剂量后 1 年内，血清型 A 和 C 的血清保护作用明显减弱。
