China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein vaccine will be evaluated in individuals over three years old who have completed basic immunization or booster shots.
SCTV01E Vaccine Profile
SCTV01E is a next-generation multivalent recombinant protein vaccine designed to address the declining protection of existing vaccines against fast-mutating COVID-19 variants. The vaccine aims to boost antibody titers and provide broad-spectrum cross-protection against current and potential future variants. SCTV01E has already been approved for clinical use in the United Arab Emirates (UAE), Jordan, and other countries, where it has demonstrated outstanding broad-spectrum cross-protection advantages and high efficiency in preventing infections from new variants.
Clinical Study Results
Previously, Sinocelltech released preliminary interim analysis results from a Phase III clinical study of SCTV01E and the recombinant COVID-19 bivalent (Alpha + Beta variants) S trimer protein vaccine SCTV01C in the UAE. On the 28th day after the booster shot, both SCTV01E and SCTV01C were able to induce the production of very high and high antibody titers against a variety of major variants. The vaccines also induced uniform, high-titer neutralizing antibodies regardless of baseline titers. These results highlight the vaccines’ potential for efficient infection prevention against new variants that may emerge in the future.-Fineline Info & Tech
