King J C, Fast P E, Zangwill K M, Weinberg G A, Wolff M, Yan L, Newman F, Belshe R B, Kovacs A, Deville J G, Jelonek M
Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Pediatr Infect Dis J. 2001 Dec;20(12):1124-31. doi: 10.1097/00006454-200112000-00006.
To assess the safety of live, attenuated influenza vaccine (LAIV) administered to relatively asymptomatic or mildly symptomatic HIV-infected children and non-HIV-infected children.
Twenty-five non-HIV and 24 HIV-infected children (CDC Class N or A1,2) were enrolled into this double blind, placebo-controlled study. Children were randomized within each HIV status group to one of two dosing regimens: Regimen 1, Dose 1 = LAIV, Dose 2 = placebo, Dose 3 = LAIV; or Regimen 2, Dose 1 = placebo, Dose 2 = LAIV, Dose 3 = LAIV. Study doses were separated by 28 to 35 days. Reactogenicity events within 10 days and adverse events within 28 to 35 days after each study dose were recorded. Blood HIV RNA concentrations, CD4 counts and CD4% were measured throughout the study on HIV-infected children. Quantitative influenza cultures were performed on nasal aspirates collected periodically from all children up to 28 to 35 days after each study dose. Influenza isolates were assessed for retention of the temperature-sensitive phenotype. Serum influenza HAI antibodies were measured before and after each LAIV vaccination.
No significant differences were found in rates of reactogenicity events and vaccine-related adverse events after placebo or the first dose of LAIV within each HIV status group, nor were differences found between HIV-infected and HIV-uninfected children after each dose of LAIV. Overall none of the HIV-infected children experienced a significant LAIV-related serious adverse event or influenza-like illness, making the one sided 95% CI of such a serious event occurring after LAIV 0 to 12%. No significant changes in geometric mean HIV RNA concentrations, CD4 counts or CD4% or prolonged or increased quantity of LAIV virus shedding occurred in HIV-infected children after receiving either dose of LAIV. All recovered influenza isolates retained the temperature-sensitive phenotype. After two doses of LAIV, 83% of the non-HIV-infected and 77% of the HIV-infected children had a > or = 4-fold rise in influenza antibody to at least one of the three LAIV strains.
If relatively healthy HIV-infected children become exposed to LAIV inadvertently, then serious adverse outcomes would not be expected to occur frequently.
评估给相对无症状或症状轻微的感染HIV儿童及未感染HIV儿童接种减毒活流感疫苗（LAIV）的安全性。
25名未感染HIV儿童和24名感染HIV儿童（疾病控制与预防中心N类或A1、2类）被纳入这项双盲、安慰剂对照研究。儿童在每个HIV感染状态组内随机分为两种给药方案之一：方案1，第1剂 = LAIV，第2剂 = 安慰剂，第3剂 = LAIV；或方案2，第1剂 = 安慰剂，第2剂 = LAIV，第3剂 = LAIV。研究剂量间隔28至35天。记录每次研究剂量后10天内的反应原性事件和28至35天内的不良事件。在整个研究过程中对感染HIV儿童测量血液HIV RNA浓度、CD4细胞计数和CD4%。在每次研究剂量后长达28至35天内，定期从所有儿童采集鼻吸液进行定量流感培养。评估流感分离株温度敏感表型的保留情况。在每次LAIV疫苗接种前后测量血清流感血凝抑制（HAI）抗体。
在每个HIV感染状态组内，安慰剂或首剂LAIV后反应原性事件和疫苗相关不良事件的发生率无显著差异，每次LAIV剂量后感染HIV儿童和未感染HIV儿童之间也无差异。总体而言，没有感染HIV的儿童发生与LAIV相关的严重不良事件或流感样疾病，使得LAIV后发生此类严重事件的单侧95%置信区间为0至12%。感染HIV儿童在接受任一剂LAIV后，几何平均HIV RNA浓度、CD4细胞计数或CD4%均无显著变化，LAIV病毒排出量也未延长或增加。所有回收的流感分离株均保留温度敏感表型。两剂LAIV后，83%的未感染HIV儿童和77%的感染HIV儿童针对三种LAIV毒株中至少一种的流感抗体升高≥4倍。
如果相对健康的感染HIV儿童无意中接触到LAIV，预计不会频繁发生严重不良后果。
