- What are RSV Clinical Trials?
- Why is RSV Immunization Clinical Research Important?
- Types of RSV Clinical Trials
- Sanofi’s Commitment to RSV Clinical Trials
- Explore Sanofi’s Clinical Trials and Studies
- References
Respiratory syncytial virus (RSV) causes a wide range of respiratory diseases, including upper and lower respiratory tract infections. It is one of the leading causes of acute lower respiratory infections in children across the globe, and can also cause severe disease in older adults.1
What are RSV Clinical Trials?
RSV clinical trials are research studies where researchers, volunteers and pharmaceutical companies come together and collaborate for controlled testing of innovative RSV treatment and prevention options.
Interested and eligible volunteers are recruited via a highly selective and controlled screening process. All RSV clinical trial participants are educated about the possible risks and outcomes of the clinical trial, and can opt out at any time.
Why is RSV Immunization Clinical Research Important?
RSV infections usually only present with mild cold-like symptoms. However, infants, children and adults over the age of 60 are at a higher risk of severe disease.1 Nearly every child will get RSV by the time they are 2 years old, and it remains a leading cause of hospitalization in babies.2,3 Studies show that hospitalization rates are higher for the elderly infected with RSV who also have existing respiratory conditions such as asthma and COPD.1
Currently, RSV management options are limited to supportive care, such as oxygen therapy.1
Clinical trials are therefore important to test new vaccines and immunizations to help defend at-risk groups like infants and older adults against RSV infection.
Importance of RSV Disease Prevention
RSV infections are very common, and the severity of which can range from mild flu-like symptoms to severe complications of the respiratory system that may require hospitalization.1-3 Due to the lack of RSV-specific therapeutics, the focus is on prevention of RSV disease.4
Preventative options are available for some groups, including infants, older adults and for use in pregnant women to help protect their baby.5 Additional prevention options are being investigated in RSV adult and pediatric clinical trials.
Types of RSV Clinical Trials
Researchers are investigating different avenues of prevention and treatment. The main pillars of RSV clinical trials include vaccine development, monoclonal antibodies and antiviral drugs.
- Vaccines: these include mRNA and protein-based vaccines.6
- Monoclonal antibodies: these target the F-protein (fusion protein) used by the virus to infect a host.7
- Antiviral drugs: these work by disrupting the life cycle of RSV.4
Sanofi’s Commitment to RSV Clinical Trials
Here at Sanofi, we are committed to R&D efforts into RSV disease prevention in adults and children.8
Explore Sanofi’s Clinical Trials and Studies
References
- Respiratory syncytial virus (RSV). Accessed May 20, 2025. https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus-(rsv)
- CDC. Preliminary Estimates of RSV Burden for 2024-2025. Respiratory Syncytial Virus Infection (RSV). March 19, 2025. Accessed May 20, 2025. https://www.cdc.gov/rsv/php/surveillance/burden-estimates.html
- CDC. RSV in Infants and Young Children. Respiratory Syncytial Virus Infection (RSV). September 20, 2024. Accessed June 6, 2025. https://www.cdc.gov/rsv/infants-young-children/index.html
- Feng Z, Xie Z, Xu L. Current antiviral therapies and promising drug candidates against respiratory syncytial virus infection. Virologica Sinica. 2025;40(2):147-156. doi:10.1016/j.virs.2025.01.003
- Respiratory Syncytial Virus (RSV). U.S. Food and Drug Administration. October 25, 2024. Accessed May 20, 2025. https://www.fda.gov/consumers/covid-19-flu-and-rsv/respiratory-syncytial-virus-rsv
- Deng L, Cao H, Li G, Zhou K, Fu Z, Zhong J, Wang Z, Yang X. Progress on Respiratory Syncytial Virus Vaccine Development and Evaluation Methods. Vaccines (Basel). 2025 Mar 12;13(3):304. doi:10.3390/vaccines13030304
- Alastair Murray, Helen Y. Chu, A promise fulfilled: Updates on respiratory syncytial virus vaccines and monoclonal antibodies, Journal of Allergy and Clinical Immunology, Volume 157, Issue 1, 2026, Pages 38-44, doi.org/10.1016/j.jaci.2025.10.023.
- NCT06583031. Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years. Accessed May 20, 2025 https://clinicaltrials.gov/study/NCT06583031
