CRV-101 Vaccine Description
CRV-101 is a next-generation shingles vaccine candidate designed to maximize the CMI protection by combining the gE protein antigen with our proprietary adjuvant.
Curevo's CRV-101 is an investigational adjuvanted sub-unit vaccine for the indication of the prevention of Herpes Zoster in older adults. The adjuvanted sub-unit vaccine strategy contrasts with traditional approaches using live killed or attenuated viruses. Sub-unit vaccines do not contain virus components and cannot cause infection. The adjuvant component was specifically engineered to produce an optional immune response while using a smaller amount of adjuvant with a targeted structure-function approach.
An effective varicella-zoster virus (VZV) vaccine requires a potent induction of VZV-specific cell-mediated immunity(CMI) since reduced CMI to VZV has been associated with increased risks of developing shingles. These CMI responses through triggering antigen-specific T cells that eliminate infected cells in the system.
Curevo is a Seattle, Washington, based clinical-stage company, with partners including South Korea’s Mogam Institute for Biomedical Research and GC Pharma. For more information, please visit www.curevovaccine.com.
CRV-101 Vaccine Indication
CRV-101 is currently indicated to prevent shingles in adults age 50 and older.
CRV-101 Vaccine Dosage
The Phase 1 study included 89 subjects, with solicited reactogenicity adverse events consisting of no grade 3 local injection site events and only one grade 3 systemic event (fever) in the highest dose group.
CRV-101 Vaccine News
Septemeber 15, 2020 - Curevo Vaccine announced antibody response data from its completed Phase 1 study investigating the safety, tolerability, and immune system response of CRV-101 in several formulations.
September 26, 2019 - Curevo, Inc. announced encouraging preliminary Phase I safety and tolerability results of their Shingles vaccine candidate, CRV-101. Interim trial results demonstrating a promising safety and tolerability profile of the vaccine in 90 healthy adults ≥18 to <50 were presented in an oral presentation at the 44th annual International Herpesvirus Workshop in Knoxville, Tennessee.
November 5, 2018 - Curevo announced that the U.S. FDA has advanced the company's Investigational New Drug application for CRV-101.
Clinical Trial NCT03820414: Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects: last updated on July 29, 2020.
The Phase 1 study included 89 subjects, with solicited reactogenicity adverse events consisting of no grade 3 local injection site events and only one grade 3 systemic event (fever) in the highest dose group. Key Antibody Response findings of the Phase I Trial:
- Immunogenicity Vaccine Response Rate (more than four-fold increase over baseline) was 100% one month after 2nd injection (D84) across all dosing cohorts
- The most robust response had an 82.5 median fold increase over pre-vaccination that remained 25-fold at the one-year durability timepoint
- Anti-gE antibody geometric mean concentrations remain well above pre-vaccination levels at one year across all dosing cohorts