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Preliminary phase 1 data showed that RSV neutralizing antibodies for non-adjuvanted SCB-1019 matched GSK’s AS01E-adjuvanted RSV vaccine, Arexvy.
Clover Biopharmaceuticals announced positive preliminary immunogenicity and safety data from its phase 1 trial evaluating the company’s RSV vaccine candidate, SCB-1019, head-to-head against GSK’s AS01E-adjuvanted RSV vaccine (Arexvy).
The ongoing phase 1 study includes 70 older adults and elderly participants who received either SCB-1019—a non-adjuvanted bivalent RSV prefusion-stabilized F-Trimer subunit vaccine candidate based on Clover's Trimer-Tag vaccine technology platform—Arexvy, or saline placebo.
Preliminary immunogenicity results included the following:
Regarding safety and reactogenicity, results showed significantly lower rates of local adverse events (AEs) for SCB-1019 (16.7%) compared to Arexvy (76.7%), according to the press release. SCB-1019 was generally well-tolerated, and local and systemic AEs were generally mild among people who received SCB-1019 and those who received saline placebo. Researchers did not report any vaccine-related serious AEs, AEs of special interest, or AEs leading to discontinuation.
Based on these positive phase 1 findings, Clover said it plans to start clinical trials in 2025 assessing the RSV vaccine candidate in an RSV revaccination setting and as part of a respiratory combination vaccine.
"We are pleased to announce positive head-to-head clinical data for our non-adjuvanted SCB-1019 RSV vaccine candidate compared to AS01E-adjuvanted AREXVY, indicating our potential best-in-class combined efficacy & safety profile," Joshua Liang, chief executive officer, board director, Clover, said in the press release. "While currently approved protein-based RSV vaccines are safe & effective when given as an initial dose, the ability to re-vaccinate effectively when protection against RSV disease wanes and the prevention of respiratory disease caused by other viruses related to RSV both remain unaddressed & high unmet needs globally. We look forward to evaluating SCB-1019 in an RSV re-vaccination setting and as part of a respiratory combination vaccine in clinical trials in 2025."
Reference: Clover announces positive clinical data for RSV vaccine candidate SCB-1019 compared head-to-head versus GSK's AREXVY. News release. Clover Biopharmaceuticals. October 28, 2024. Accessed October 29, 2024. https://www.prnewswire.com/news-releases/clover-announces-positive-clinical-data-for-rsv-vaccine-candidate-scb-1019-compared-head-to-head-versus-gsks-arexvy-302289224.html