SEATTLE–(BUSINESS WIRE)–Curevo Vaccine, a clinical stage biopharmaceutical company developing next generation vaccines for patients with infectious disease of global importance, today announced antibody response data from its completed Phase 1 study investigating the safety, tolerability, and immune system response of CRV-101 in several formulations. The administration of Curevo’s adjuvanted sub-unit Shingles investigational vaccine resulted in a robust antibody response against a key component (gE) of the shingles virus at 1 month after 2nd vaccination, and at one year. Curevo will present results from their Phase I trial on the 30th of September 2020 at the virtual World Vaccine Congress Washington conference.
“The data is very exciting! CRV-101 is well tolerated by the vaccine recipient and the immune response measured by antibodies in the blood suggests that CRV-101 has the potential to be as good as the currently licensed adjuvanted subunit vaccine. This will be evaluated in older adults in phase 2.”
“Our Phase 1 study has shown that the vaccine was extremely well-tolerated by healthy adults and also generated a robust and durable antibody immune response across the doses evaluated,” said George Simeon, the Chief Executive Officer of Curevo. “These results exceed our expectations and support our plan to rapidly advance to a large Phase 2b clinical trial.”
Curevo Scientific Advisory Board member, Myron Levin, MD, said, “The data is very exciting! CRV-101 is well tolerated by the vaccine recipient and the immune response measured by antibodies in the blood suggests that CRV-101 has the potential to be as good as the currently licensed adjuvanted subunit vaccine. This will be evaluated in older adults in phase 2.”
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. “The frequency of grade 2 individual solicited reactogenicity events, including pain at injection site, were less than 6.5% over all CRV-101 doses. Currently licensed adjuvanted gE subunit vaccine studies have shown higher reactogenicity in younger populations, so we do not expect to see increased reactogenicity in the target age group of 50 years or older,” said Lisa Shelton, ARNP, Associate Director of Clinical Operations. This investigational vaccine was designed to elicit immune responses known to play a key role against the Shingles virus.
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
Additional information can be found on clinicaltrials.gov identifier: NCT03820414.
Original press release posted here.