- Naobios and SGS have partnered to manufacture a Respiratory Syncytial Virus (RSV) human viral challenge agent for use in Controlled Human Infection Model (CHIM) studies.
- The RSV challenge agent was produced under cGMP conditions, with 12 participants inoculated in October 2025 in Antwerp, achieving a 100% attack rate with mild, self-resolving pathology.
Naobios, a contract development and manufacturing organization (CDMO) specializing in bioprocess development and GMP production of virus-based products, has partnered with SGS to manufacture a Respiratory Syncytial Virus (RSV) human viral challenge agent for Controlled Human Infection Model (CHIM) studies.
The challenge agent was produced under cGMP conditions using a 2015 A-strain isolate that mirrors currently circulating RSV strains. The agent is intended for use in CHIM studies conducted by SGS to generate data on vaccine efficacy and immune response dynamics. Naobios is responsible for the development, manufacturing, and filling of the challenge agent, while SGS oversees clinical evaluation.
To generate first-in-human proof-of-concept data, 12 healthy participants were inoculated in October 2025 at the SGS Clinical Pharmacology Unit in Antwerp, Belgium. The study reported a 100% attack rate with mild, self-resolving pathology.
“In response to the growing use of CHIM studies, we have invested to extend our range of services, enabling us to meet the critical needs of clients worldwide.”
Eric Le Forestier, General Manager of Naobios
Human viral challenge agents are used in controlled clinical trials in which healthy volunteers receive a carefully measured dose of a pathogen under ethical, regulatory, and biosafety oversight to evaluate vaccines or treatments. Naobios has manufactured 36 GMP batches of such agents for viruses including SARS-CoV-2, RSV, hMPV, and influenza, supporting vaccine development efforts conducted through specialized CHIM centers such as SGS.
