Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
GSK, Wavre, Belgium.
Vaccine. 2020 Feb 28;38(10):2350-2360. doi: 10.1016/j.vaccine.2020.01.062. Epub 2020 Feb 5.
Nasopharyngeal carriage (NPC) of Streptococcus pneumoniae is a precondition for pneumococcal disease and a source of transmission. This trial evaluated NPC of S. pneumoniae and other pathogens post-vaccination with the pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) South African children.
In this phase III, open, single-centre, controlled study (ClinicalTrials.gov: NCT00829010), 484 children were stratified by HIV status: 83 HIV+, 101 HEU, and 300 HUU. HIV+ and HEU children received a 3 + 1 PHiD-CV vaccination schedule: primary vaccination, age 6/10/14 weeks, and booster dose, age 9-10 months. HUU infants were randomised (1:1:1) to 3-dose priming and booster (HUU/3+1); 3-dose priming without booster (HUU/3+0); or 2-dose priming and booster (HUU/2+1). Bacterial NPC was assessed 8 times up to 24-27 months of age.
Overall pneumococcal carriage rates were similar across 3+1 groups irrespective of HIV status; trends towards higher carriage rates in the HIV+ than HEU and HUU/3+1 groups were observed at 24-27 months of age. In HUU children, carriage of any pneumococcal serotype was similar for the three different dosing schedules at all timepoints; carriage of vaccine-type pneumococci tended to be lower at 16-19 months and 24-27 months of age in children who had received a booster dose (HUU/2+1 and HUU/3+1 groups) than in the HUU/3+0 group. Carriage rates of NTHi, Staphylococcus aureus and Moraxella catarrhalis were comparable between all groups.
HIV infection or exposure did not seem to alter the effect of PHiD-CV on pneumococcal NPC in children during their first 2 years of life. NPC prevalence of vaccine-type pneumococci following vaccination series tended to be lower in children who had received a booster dose in comparison to those who had not.
鼻咽部携带（NPC）肺炎链球菌是肺炎球菌病的前提条件，也是传播的来源。本试验评估了人类免疫缺陷病毒（HIV）感染（HIV+）、HIV 暴露未感染（HEU）和 HIV 未暴露未感染（HUU）南非儿童接种肺炎球菌非分型流感嗜血杆菌（NTHi）蛋白 D 结合疫苗（PHiD-CV）后 NPC 及其他病原体的情况。
在这项 III 期、开放、单中心、对照研究（ClinicalTrials.gov：NCT00829010）中，484 名儿童按 HIV 状态分层：83 名 HIV+、101 名 HEU 和 300 名 HUU。HIV+和 HEU 儿童接受了 3+1 次 PHiD-CV 接种计划：基础免疫，6/10/14 周龄；加强免疫，9-10 月龄。HUU 婴儿随机接受 3 剂初免和加强免疫（HUU/3+1）、3 剂初免无加强免疫（HUU/3+0）或 2 剂初免和加强免疫（HUU/2+1）。在 24-27 月龄时，共评估了 8 次鼻咽部细菌携带情况。
无论 HIV 状态如何，3+1 组的总体肺炎球菌携带率相似；在 24-27 月龄时，HIV+组比 HEU 组和 HUU/3+1 组的携带率呈上升趋势。在 HUU 儿童中，在所有时间点，三种不同的给药方案对任何肺炎球菌血清型的携带情况相似；在接受加强免疫的儿童（HUU/2+1 组和 HUU/3+1 组）中，16-19 月龄和 24-27 月龄时，疫苗型肺炎球菌的携带率低于 HUU/3+0 组。NTHi、金黄色葡萄球菌和卡他莫拉菌的携带率在所有组之间相似。
在儿童生命的前 2 年，HIV 感染或暴露似乎并未改变 PHiD-CV 对儿童鼻咽部肺炎球菌 NPC 的影响。与未接受加强免疫的儿童相比，接种疫苗系列后，疫苗型肺炎球菌的 NPC 患病率较低。
