An investigational vaccine against respiratory syncytial virus (RSV), developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health, has entered a phase 1 clinical trial.
The trial, called VRC 317, will assess the dosing, safety, and tolerability of the investigational RSV vaccine, called DS-Cav1 (ClinicalTrials.gov identifier: NCT03049488). Recruitment is currently underway, and the study will enroll healthy adults between the ages of 18 and 50 years.
Participants will be randomly assigned to receive 2 injections in the arm of the investigational vaccine 12 weeks apart, or the investigational vaccine adjuvanted with alum. Three vaccine doses will be administrated at both points: 50, 150, or 500 μg. Five people will be initially vaccinated with 50 μg, and if no serious adverse reactions are observed, then the 150-μg dosing level will begin. Again, the team will observe for serious adverse reactions at the 150-μg dosing level, and if none are observed, they will proceed to the 500-μg dose.
Participants will return for 12 clinic visits over the course of 44 weeks after the first injection. At these visits, clinicians will conduct physical exams and collect blood samples and mucous samples from the participants’ mouths and noses to measure immune responses generated by the vaccine.
A daily safety review of any new clinical information will be conducted by the study team. In addition, a Protocol Safety Review Team will examine trial safety data weekly to ensure the vaccine meets safety standards.
“RSV is underappreciated as a major cause of illness and death, not only in infants and children but also in people with weakened immune systems and the elderly,” said NIAID Director Anthony S. Fauci, MD. “A vaccine to reduce the burden of this important disease is badly needed.”
The study is expected to be completed by May 2018.
For more information, visit NIAID’s RSV web page.
Respiratory syncytial virus vaccine enters clinical testing [news release]. Bethesda, MD: National Institutes of Health. https://www.nih.gov/news-events/news-releases/respiratory-syncytial-virus-vaccine-enters-clinical-testing. Published February 22, 2017. Accessed March 6, 2017.