Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, United States.
Walter Reed Army Institute of Research, Silver Spring, MD, United States.
Vaccine. 2021 May 27;39(23):3179-3188. doi: 10.1016/j.vaccine.2021.04.031. Epub 2021 May 4.
Military trainees are at increased risk for Staphylococcus aureus colonization and infection. Disease prevention strategies are needed, but a S. aureus vaccine does not currently exist.
We enrolled US Army Infantry trainees (Fort Benning, GA) in a phase 2, randomized, double-blind, placebo-controlled trial of NDV-3A, a vaccine containing a recombinant adhesin/invasion protein of Candida albicans that has structural similarity to the S. aureus protein clumping factor A. Study participants received one intramuscular dose of NDV-3A or placebo (adjuvant alone) within 72 h of arrival on base. Longitudinal nasal and oral (throat) swabs were collected throughout the 14-week Infantry training cycle. Safety, immunogenicity, and efficacy of NDV-3A against S. aureus nasal / oral acquisition were the endpoints.
The NDV-3A candidate had minimal reactogenicity and elicited robust antigen-specific B- and T-cell responses. During the 56-day post-vaccination period, there was no difference in the incidence of S. aureus nasal acquisition between those who were randomized to receive NDV-3A vs. placebo (25.6% vs. 29.1%; vaccine efficacy [VE]: 12.1%; p = 0.31). In time-to-event analysis, there was no difference between study groups with respect to the S. aureus colonization-free interval (VE: 13%; p = 0.29). Similarly, the efficacy of NDV-3A against S. aureus oral acquisition was poor (VE: 2.4%; p = 0.52).
A single dose of NDV-3A did not prevent nasal nor oral acquisition of S. aureus in a population of military trainees at high risk for colonization.
军事受训人员感染金黄色葡萄球菌定植和感染的风险增加。需要采取疾病预防策略，但目前尚无金黄色葡萄球菌疫苗。
我们招募了美国陆军步兵新兵（佐治亚州本宁堡），进行了 NDV-3A 的 2 期、随机、双盲、安慰剂对照试验，NDV-3A 是一种含有白色念珠菌重组黏附素/侵袭蛋白的疫苗，该蛋白与金黄色葡萄球菌蛋白凝聚因子 A 具有结构相似性。研究参与者在抵达基地后 72 小时内接受一次 NDV-3A 或安慰剂（单独佐剂）的肌内注射。在 14 周的步兵训练周期中，连续采集鼻和口腔（喉咙）拭子。NDV-3A 预防金黄色葡萄球菌鼻/口腔定植的安全性、免疫原性和疗效是终点。
NDV-3A 候选疫苗具有轻微的反应原性，并引起了强大的抗原特异性 B 细胞和 T 细胞反应。在接种疫苗后的 56 天内，随机接受 NDV-3A 与安慰剂的人群中，金黄色葡萄球菌鼻定植的发生率没有差异（25.6%比 29.1%；疫苗效力[VE]：12.1%；p=0.31）。在时间事件分析中，两组在金黄色葡萄球菌定植无间隔期方面没有差异（VE：13%；p=0.29）。同样，NDV-3A 预防金黄色葡萄球菌口腔定植的效果也不佳（VE：2.4%；p=0.52）。
在高定植风险的军事受训人员中，单次剂量的 NDV-3A 不能预防金黄色葡萄球菌的鼻内和口腔定植。
