A Phase 1 clinical trial to test the safety and tolerability of an investigational vaccine against respiratory syncytial virus (RSV) has begun at the National Institutes of Health Clinical Center in Bethesda, Maryland.
The trial also will assess the vaccine’s ability to prompt an immune response in healthy adult participants, officials said.
Currently, no vaccine to prevent RSV infection or drug to treat it is available. The monoclonal antibody palivizumab is licensed in the U.S. for preventing serious lower respiratory tract disease caused by RSV in high-risk children, but it is not licensed for use in the general population.
The study, called VRC 317, will enroll healthy adults from 18-50. Participants will be randomly assigned to receive two injections in the arm at 12 weeks apart with either the investigational vaccine or the investigational vaccine adjuvanted with alum.
Alum is a chemical compound commonly added to vaccines to enhance the body’s immune response.
Participants will return for 12 clinic visits over 44 weeks after the first injection. At these visits, study clinicians will conduct physical exams and collect blood samples. They will also test mucous samples from volunteers’ mouths and noses to measure the immune responses generated.
