US NIH division the National Institute of Allergy and Infectious Diseases (NIAID) has initiated a Phase I clinical trial to evaluate an investigational intranasal vaccine called SeVRSV to protect from respiratory syncytial virus (RSV).
SeVRSV consists of a modified mouse virus (Sendai virus) that carries RSV genetic material intended to express RSV fusion protein in the recipient in order to trigger RSV-specific antibodies and T-cells.
According to the NIH, the Sendai virus vaccine platform demonstrated favourable tolerability profile in human clinical trials of other infectious disease vaccines such as HIV treatments.
The SeVRSV vaccine was developed by US-based St Jude Children’s Research Hospital and manufactured by its Children’s GMP.
NIAID director Anthony Fauci said: “RSV infection is a significant cause of illness and disease among the most vulnerable populations. A vaccine to prevent disease from this pervasive and sometimes deadly virus is urgently needed.”
The Phase I trial is designed to investigate the vaccine candidate’s safety and ability to stimulate an immune response in 25 healthy volunteers aged 18 to 45 years.
It is being conducted at the Cincinnati Children’s Hospital Medical Center, which is one of the Vaccine and Treatment Evaluation Units (VTEUs) funded by NIAID.
Over a term of 29 days, participants are required to make five clinic visits when they will be analysed for adverse reactions. In addition, their blood samples and nasal washes will be tested for the presence of RSV-specific antibodies.
Subsequently, the trial involves follow-ups at two and six months following vaccination.