CRV-101 Vaccine Description For 2022
Curevo Vaccine's CRV-101 is an adjuvanted subunit vaccine candidate designed to maximize cell-mediated immunity (CMI) protection by combining the gE protein antigen with our proprietary adjuvant. CRV-101 strategy contrasts with traditional approaches using live-killed or attenuated viruses. Sub-unit vaccines do not contain virus components and cannot cause infection addition, 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.
CRV-101 was specifically designed to produce an optimal immune response while using a smaller amount of adjuvant with the intention of achieving similar efficacy but with fewer side effects than the currently-approved shingles vaccine. CRV-101 enjoys a highly scalable, straightforward manufacturing profile explicitly designed to eliminate the potential for supply disruptions.
In the Phase 1 program, CRV-101 demonstrated robust immunogenicity as measured by humoral and cellular responses with no grade 3 injection site reactions and a low (1.3%) rate of grade 3 systemic side effects.
Curevo is a Bothell, WA-based clinical-stage company with partners in South Korea's Mogam Institute for Biomedical Research and GC Pharma. The Series A round was led by RA Capital Management. Other investors include Adjuvant Capital, Janus Henderson Investors, EN Investment, and founding investor GC Pharma. For more information, please visit www.curevovaccine.com.
CRV-101 Vaccine Indication
Once children are infected with chickenpox, the Varicella Zoster Virus (VZV) remains in the sensory ganglia, says the U.S. CDC. VZV typically remains inactive and reactivates to cause shingles with age-related immunosenescence. The CRV-101 vaccine candidate is currently indicated to prevent shingles in adults 50 and older.
CRV-101 Vaccine Side Effects
The CRV-101 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. According to the U.S. CDC website, about 16% receiving Shingrix® experienced side effects preventing them from participating in regular activities.
CRV-101 Vaccine Dosage
A Phase 1, Group 1 Subjects receive two doses of the candidate CRV-101 formulation 1, administered intramuscularly (IM) in the deltoid region of the non-dominant arm, according to a 0, 2 Month schedule. Group 2 Subjects receive two doses of the candidate CRV-101 formulation 2, administered intramuscularly (IM) in the deltoid region of the non-dominant arm, according to a 0, 2 Month schedule. Furthermore, Groups 3 and 4 received increasing doses.
CRV-101 Vaccine News For 2021 - 2022
November 16, 2022 - Curevo Vaccine announced the closing of a $26 million Series A1 financing round.
September 15, 2022 - Curevo Vaccine announced the completion of enrollment in a Phase 2b trial of their CRV-101 subunit vaccine to prevent the reactivation of the varicella-zoster virus in older adults.
February 10, 2022 - Curevo Vaccine announced the closing of a $60 million Series A financing round.
March 18, 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, 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 the vaccine's promising safety and tolerability profile 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.
CRV-101 Clinical Trial
The phase two study - enrolled 678 participants across eleven U.S. sites, randomized to a high- or low-dose CRV-101 arm or Shingrix. Participants received two doses, two months apart, as per current practice for a shingles vaccine. Eligibility criteria included adults over 50 with no prior varicella zoster virus vaccination or history of shingles. They were broadly representative of the potential non-immunosuppressed patient population for a shingles vaccine. The primary endpoints focus on safety and immunologic outcomes, including the occurrence of local and systemic side effects, antibody levels at month three, comparison of the reactogenicity of CRV-101 to Shingrix, and the occurrence of serious adverse events. Patient enrollment started in February 2022, and topline data from this Phase 2b trial are expected in January 2023.
Clinical Trial NCT03820414: Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects. 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, in Q4 2021. Phase 1b study objectives include evaluating the safety, tolerability, and immunogenicity of two intramuscular vaccinations approximately two months apart in HIV-infected children.
In the Phase 1 trial, CRV-101 demonstrated very robust immunogenicity as measured by humoral and cellular responses with no grade 3 injection site side effects and a 1.3% rate of grade 3 systemic side effects ("grade 3" side effects are those vaccination-related reactions severe enough to prevent normal activities).
