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 subunit vaccine for the indication of the prevention of Herpes Zoster in older adults. The adjuvanted subunit 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 says the company.
Curevo is a Seattle, Washington, based clinical-stage company with partners in South Korea’s Mogam Institute for Biomedical Research and GC Pharma. For more information, please visit www.curevovaccine.com.
CRV-101 Vaccine Indication
The CRV-101 vaccine candidate is currently indicated to prevent shingles in adults age 50 and older.
The Phase 1 study included 90 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 Dosage
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind, Antigen Dose-Escalation and Adjuvant Dose-Ranging Clinical Trial is Evaluating the Safety, Tolerability, and Immunogenicity of various CRV-101 dosages in 90 Healthy Adult Subjects.
CRV-101 Vaccine News
March 30, 2021 - Curevo Vaccine announced approval was granted to move forward with a Phase 1b pediatric clinical trial in South Africa to evaluate the safety, efficacy, and immunogenicity of its non-live investigational vaccine CRV-101 against varicella (chickenpox) in immunocompromised pediatric HIV-infected populations. Curevo Vaccine submitted its clinical trial application to the South African Health Products Regulatory Authority (SAHPRA), an entity of the South African Government’s National Health Department, in November 2020.
September 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 had advanced the company's Investigational New Drug application for CRV-101.
Clinical Trial
Clinical Trial NCT03820414: Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects: last updated on February 11, 2021. 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. Actual Study Completion Date: April 30, 2020.
A Phase 1b clinical trial will be conducted at the Family Center for Research with Ubuntu, at Tygerberg Academic Hospital, a research center within Stellenbosch University in Cape Town, South Africa, Q4 2021. Phase 1b study objectives include evaluating the safety, tolerability, and immunogenicity of two intramuscular vaccinations approximately 2 months apart in HIV-infected children.
