Respiratory Syncytial Virus (RSV) Investigational Vaccine in Infants Aged 6 and 7 Months Likely to be Unexposed to RSV

Summary

The purpose of this study is to provide critical information on the safety, reactogenicity and immunogenicity profile of the investigational recombinant chimpanzee adenovirus Type 155-vectored RSV (ChAd155-RSV) vaccine in infants likely to be unexposed to RSV and will assess a single lower dose and a higher two dose regimen, before moving to future studies. This study will also assess if there is a risk of 'vaccine-induced enhanced RSV disease' after vaccination of these infants with the ChAd155-RSV vaccine.

Timeline

Start

2019-04-08

Primary completion

2020-01-16

Completion

2021-07-22

Publications

• Saez-Llorens X, Norero X, Mussi-Pinhata MM, Luciani K, de la Cueva IS, Diez-Domingo J, Lopez-Medina E, Epalza C, Brzostek J, Szymanski H, Boucher FD, Cetin BS, De Leon T, Dinleyici EC, Gabriel MAM, Ince T, Macias-Parra M, Langley JM, Martinon-Torres F, Ramet M, Kuchar E, Pinto J, Puthanakit T, Baquero-Artigao F, Gattinara GC, Arribas JMM, Ramos Amador JT, Szenborn L, Tapiero B, Anderson EJ, Campbell JD, Faust SN, Nikic V, Zhou Y, Pu W, Friel D, Dieussaert I, Lopez AG, McPhee R, Stoszek SK, Vanhoutte N. Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6-7 Months of age: A Phase 1/2 Randomized Trial. J Infect Dis. 2024 Jan 12;229(1):95-107. doi: 10.1093/infdis/jiad271.

Drugs

Indications