VRC-RSVRGP084-00-VP (DS-Cav1) was developed by VRC, NIAID and is composed of the respiratory syncytial virus (RSV) fusion (F) glycoprotein ectodomain assembled as a trimer stabilized in its prefusion native conformation with a foldon trimerization domain at the C-terminus and 4 internal mutations designated DS-Cav1 (4.1DHFR_RSVAF).
The sequence is based on the RSV A2 strain from subtype A. The adjuvant is an aluminum hydroxide suspension (alum).
DS-Cav1)is a vaccine candidate to prevent RSV.
DS-Cav1 vaccinations are administered as an intramuscular injection into the deltoid muscle.
In the current clinical trial, subjects will receive a 2-injection regimen.
Clinical Trial NCT03049488: Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
- This is a Phase I, open-label, dose-escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-RSVRGP084-00-VP alone or with alum adjuvant in a 2-injection regimen.
- The hypotheses are that the vaccine will be safe and tolerable for human administration, and will induce a detectable immune response.
- The primary objective is to evaluate the safety and tolerability of the investigational vaccine at 3 dose levels administered alone or with alum adjuvant as a homologous boost in healthy adults.
- Secondary objectives relate to humoral and cellular immunogenicity of the investigational vaccine regimen.