DS-Cav1 RSV Vaccine Description
VRC-RSVRGP084-00-VP (DS-Cav1) was 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).
The development of RSV vaccines has been identified as a priority for the WHO Initiative for Vaccine Research. RSV is a common respiratory virus that usually causes mild, cold-like symptoms.
Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. In fact, RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States. It is also a significant cause of respiratory illness in older adults, says the CDC.
The phase 1 study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID).
DS-Cav1 RSV Vaccine Indication
DS-Cav1 is a vaccine candidate to prevent RSV. Each year, it is estimated that more than 177,000 older adults are hospitalized and 14,000 of them die in the United States due to RSV infection.
Older adults who get very sick from RSV may need to be hospitalized. Some may even die. Older adults are at greater risk than young adults for serious complications from RSV because our immune systems weaken when we are older, says the CDC.
DS-Cav1 RSV Vaccine Dosage
DS-Cav1 vaccinations are administered as an intramuscular injection into the deltoid muscle.
DS-Cav1 RSV Vaccine News
December 11, 2019 - Crystal Structure and Immunogenicity of the DS-Cav1-Stabilized Fusion Glycoprotein From Respiratory Syncytial Virus Subtype B.
August 7, 2019 - New RSV vaccine immunogenicity improved with protein engineering.
DS-Cav1 RSV Vaccine Clinical Trials
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. Last updated on April 22, 2020.
- 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.