A combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine in healthy adults: a randomized, placebo-controlled phase 1 trial.

Trivalent Salmonella conjugate vaccine (TSCV) consists of Vi capsule polysaccharide conjugated to tetanus toxoid and core-plus-O-polysaccharides from the two most prevalent invasive NTS serovars conjugated to flagellin subunits.

三价沙门氏菌结合疫苗（TSCV）由Vi囊膜多糖与破伤风类毒素结合而成，以及从两种最常见的侵袭性NTS血清型中提取的核心加O-多糖与鞭毛蛋白亚单位结合而成。

We conducted a first-in-human, randomized, placebo-controlled, phase 1 trial evaluating the safety and immunogenicity of TSCV.

我们进行了一项首次人体、随机、安慰剂对照的1期试验，评估TSCV的安全性和免疫原性。

A total of 22 healthy adults aged 18-45 years were randomly allocated to 6.25-µg TSCV (n = 8), 12.5-µg TSCV (n = 10) or placebo (n = 4).

共有22名年龄在18至45岁之间的健康成人随机分配接受6.25微克TSCV（n=8）、12.5微克TSCV（n=10）或安慰剂（n=4）。

The primary objective was the assessment of safety.

主要目标是对安全性进行评估。

The co-primary immunogenicity objective was the serum IgG response against the three vaccine polysaccharides and two flagellin carrier proteins.

共同的主要免疫原性目标是对三种疫苗多糖和两种鞭毛蛋白载体蛋白的血清IgG反应进行评估。

Here we show that TSCV was safe and well tolerated, meeting the prespecified safety endpoints, with the most common solicited symptom being short-lived injection site pain.

我们在这里展示TSCV是安全且耐受性良好的，满足了预先设定的安全性终点，最常见的征询症状是短暂的注射部位疼痛。

For each of the three polysaccharides, immune responses, as demonstrated by ≥4-fold increases over baseline, were observed among all (100%) vaccinees, and no responses were elicited in the placebo group, meeting the prespecified immunogenicity endpoints.

对于三种多糖中的每一种，通过≥4倍于基线的增加显示出的免疫反应，在所有（100%）疫苗接种者中均有所观察，而在安慰剂组中未引发任何反应，满足了预先设定的免疫原性终点。

The two flagellin components elicited 88% (7/8) and 100% (8/8) responses among 6.25-µg and 12.5-µg TSCV recipients and no placebo recipients.

这两种鞭毛蛋白成分在6.25微克和12.5微克TSCV接种者中分别引发了88%（7/8）和100%（8/8）的反应，而安慰剂接种者中没有反应。

These data warrant further evaluation of TSCV for protection against invasive Salmonella disease.

这些数据证明了有必要进一步评估TSCV对侵袭性沙门氏菌病的保护作用。

ClinicalTrial.gov identifier: NCT03981952 .

临床试验.gov 标识符：NCT03981952 .