Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status
Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status
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DOI：
10.1097/md.0000000000005881
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发表时间：
2017-01-01
期刊：
影响因子：
1.6
通讯作者：
Schuerman, Lode
中科院分区：
文献类型：
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作者：
Madhi, Shabir A.;Koen, Anthonet;Schuerman, Lode
背景：第三阶段，开放标签，单中心，南非对照研究(临床试验。目的：评价人类免疫缺陷病毒(HIV)感染(HIV+)、HIV暴露未感染(HEU)和HIV未暴露未感染(HUU)儿童接种10价肺炎球菌非分型流感嗜血杆菌蛋白D结合疫苗(PHiD-CV)的免疫原性、反应性和安全性。结果：在HIV+、HEU和HUU组的83、101和100名儿童中，70、91和93名儿童进入了符合方案的免疫原性队列。对于每种疫苗血清型，初免后1个月抗体浓度<gt；=0.2微克/毫升的儿童百分比为<gt；=97%，加强免疫后1个月抗体浓度<gt；=98.5%(6B和23F除外)。在初次接种后，HIV+儿童的功能性抗体反应较低：对于每种疫苗血清型，HIV+、HEU和HUU儿童中具有吞噬细胞活性(OPA)滴度=8的儿童的百分比分别为>；=72%、>；=81%和>；=79%。加强免疫后，每组87%的儿童OPA滴度=8。不同组间的反应性相似。31名(37%)HIV阳性、25名(25%)HEU和20名(20%)HUU儿童报告了1起严重不良事件。5名HIV阳性儿童和4名HEU儿童死亡。1例死亡(婴儿猝死综合征；HEU组；接种后3天)被认为与疫苗潜在相关。结论：在HIV+、HEU和HUU儿童中，PHiD-CV具有免疫原性和良好的耐受性，无论HIV感染状态如何，PHiD-CV都有可能提供实质性的好处。
Background: Phase III, open-label, single-center, controlled study in South Africa (ClinicalTrials. gov: NCT00829010) to evaluate immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) children.Methods: Children stratified by HIV status received PHiD-CV primary vaccination (age 6/10/14 weeks; coadministered with routine childhood vaccines) and booster dose (age 9-10 months). Immune responses, assessed using enzyme-linked immunosorbent and functional assays, and safety were evaluated up to 14 months post-booster.Results: Of 83, 101, and 100 children enrolled in HIV+, HEU, and HUU groups, 70, 91, and 93 were included in according-toprotocol immunogenicity cohort. For each vaccine-serotype, percentages of children with antibody concentrations >= 0.2 mu g/mL were >= 97% 1 month post-primary vaccination and >= 98.5% 1 month post-booster (except for 6B and 23F at both timepoints). Post-primary vaccination, functional antibody responses were lower in HIV+ children: for each vaccine-serotype, percentages of children with opsonophagocytic activity (OPA) titres >= 8 were >= 72%, >= 81%, and >= 79% for HIV+, HEU, and HUU children. Post-booster, >= 87% of children in each group had OPA titres >= 8. Reactogenicity was similar across groups. Thirty one (37%) HIV+, 25 (25%) HEU, and 20 (20%) HUU children reported >= 1 serious adverse event. Five HIV+ and 4 HEU children died. One death (sudden infant death syndrome; HEU group; 3 days post-dose 1) was considered potentially vaccine-related.Conclusion: PHiD-CV was immunogenic and well-tolerated in HIV+, HEU, and HUU children, and has the potential to provide substantial benefit irrespective of HIV infection status.