一项针对血清阴性成年人的1期双臂、随机、双盲、活性对照研究：口服活质粒衍生4型和7型腺病毒疫苗。

A Phase 1 Two-Arm, Randomized, Double-Blind, Active-Controlled Study of Live, Oral Plasmid-Derived Adenovirus Type 4 and Type 7 Vaccines in Seronegative Adults.

作者信息

Beaty Shannon, Collins Natalie, Karasavvas Nicos, Kuschner Robert, Hang Jun, Adhikari Anima, Maljkovic Berry Irina, Fung Christian, Walls Shannon, Betancourt Elena, Mendy Jason, Lock Michael, Gierman Emma, Bennett Sean, Shabram Paul, Warfield Kelly

机构信息

Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.

Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.

出版信息

Vaccines (Basel). 2023 Jun 12;11(6):1091. doi: 10.3390/vaccines11061091.

DOI:10.3390/vaccines11061091

PMID:37376480

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10301169/

Abstract

PXVX0047 is an investigational vaccine developed for active immunization to prevent febrile acute respiratory disease (ARD) caused by adenovirus serotypes 4 (Ad4) and 7 (Ad7). PXVX0047 consists of a modernized, plasmid-derived vaccine that was generated using a virus isolated from Wyeth Ad4 and Ad7 vaccine tablets. A phase 1 two-arm, randomized, double-blind, active-controlled study was conducted to evaluate the safety profile and immunogenicity of the investigational adenovirus vaccines. The two components of PXVX0047 were administered orally together in a single dose to 11 subjects. For comparison, three additional subjects received the Ad4/Ad7 vaccine that is currently in use by the US military. The results of this study show that the tolerability and immunogenicity of the PXVX0047 Ad7 component are comparable with that of the control Ad4/Ad7 vaccine; however, the immunogenicity of the PXVX0047 Ad4 component was lower than expected. Clinical trial number NCT03160339.

摘要

PXVX0047是一种用于主动免疫的研究性疫苗，旨在预防由腺病毒4型（Ad4）和7型（Ad7）引起的发热性急性呼吸道疾病（ARD）。PXVX0047由一种现代化的、源自质粒的疫苗组成，该疫苗是使用从惠氏Ad4和Ad7疫苗片剂中分离出的病毒制备而成。开展了一项1期双臂、随机、双盲、活性对照研究，以评估该研究性腺病毒疫苗的安全性和免疫原性。PXVX0047的两个组分以单剂量一起口服给药给11名受试者。作为比较，另外3名受试者接受了美国军方目前使用的Ad4/Ad7疫苗。该研究结果表明，PXVX0047 Ad7组分的耐受性和免疫原性与对照Ad4/Ad7疫苗相当；然而，PXVX0047 Ad4组分的免疫原性低于预期。临床试验编号为NCT03160339。