NIH launches study to evaluate RSV in healthy adults

The NIH has announced plans for its National Institute of Allergy and Infectious Diseases to conduct a pilot study to evaluate how respiratory syncytial virus infection develops in adults, and how it affects immune system responses, according to a press release.

The study aims to provide insight on how to best develop and test antivirals and vaccines that will help to combat the disease.

“Challenge studies such as this are a unique way of enabling scientists to monitor, in a controlled setting, the natural history of a disease in exquisite detail, using the most powerful tools of molecular biology,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a press release. “By studying [respiratory syncytial virus] infection in healthy adults, we hope to improve understanding of how this infection develops and determine the suitability of this particular strain of the virus for use in future [respiratory syncytial virus] vaccine and treatment trials.”

Roughly 55,000 children aged younger than 5 years are hospitalized each year and 14,000 deaths among adults aged 65 years and older are caused by respiratory syncytial virus (RSV) infections, according to the release.

The study will enroll up to 60 healthy adults, aged 18 to 50 years, who will receive a drop of liquid containing laboratory-developed respiratory syncytial virus (RSV A2) in each nostril. Participants will then remain in isolation for up to 2 weeks at the NIH Clinical Center, where they will be monitored daily for signs and symptoms of RSV infection. Monitoring will include blood draws, sampling of nasal secretions, and lung measurement tests to track the progression of the virus.

Researchers will analyze samples and test results to measure participants’ levels of virus shedding and immune protection.

Participants will follow-up at 28 and 56 days postinfection, and again at 180 days if they develop RSV disease, to be assessed for immune response durability to RSV.

If participants do not have RSV infection symptoms and test negative for RSV twice, they will be discharged from the study.

Results from the study are expected by 2017, according to the release.

Researchers said they do not foresee any volunteers becoming seriously ill after being exposed to RSV since most adults have been exposed to the virus during childhood, but in the event an unexpected or serious illness occurs, patients will receive the standard of care at the Clinical Center.

“We do not anticipate that the healthy, carefully screened adult volunteers in this study will become severely sick from the RSV challenge virus because, in general, healthy adults are repeatedly exposed to RSV in their lives and either remain asymptomatic or develop a mild to moderate cold,” Lesia K. Dropulic, MD, of the Laboratory of Infectious Diseases at NIAID, said in the release.