Friday, December 29, 2023
Jiangsu Recbio Technology Co., Ltd. is thrilled to report positive results from the interim analysis of the first-in-human (FIH) clinical trial conducted in the Philippines for its novel adjuvanted recombinant shingles vaccine, REC610. In a GSK Shingrix® active-controlled FIH clinical trial, REC610 exhibited a favorable safety and tolerability profile in healthy participants aged 40 and above after two doses. The vaccine induced robust gE-specific humoral and cellular immune responses, comparable to the Shingrix® group, with the immune response level in the REC610 group numerically higher.
In terms of safety, REC610 demonstrated a positive profile with no reports of serious adverse events (SAE), adverse events of special interest (AESI), or treatment-emergent adverse events (TEAE) leading to early discontinuation. The incidences of vaccination-related TEAEs, solicited local and systemic TEAEs, and unsolicited TEAEs were similar between the REC610 and Shingrix® groups. Most vaccination-related TEAEs were mild to moderate, resolving within 1-3 days post-vaccination. Common solicited TEAEs in the REC610 group included injection site pain, swelling, pyrexia, headache, and myalgia.
In terms of immunogenicity, REC610 induced robust gE-specific humoral and cellular immune responses, reaching peak levels at 30 days after the second vaccination. Both REC610 and Shingrix® groups demonstrated high levels of gE-specific antibodies and strong cellular immune responses. REC610 showed a numerically higher immune response level compared to the Shingrix® group, especially in terms of gE-specific antibody titers.
Shingles, a prevalent viral infectious disease, affects approximately 6 million new cases each year in China. The incidence of shingles has been trending younger. Novel adjuvanted recombinant shingles vaccines, such as REC610, have demonstrated enhanced cellular immune and protective efficacy compared to live vaccines. REC610, equipped with the independently developed adjuvant BFA01, aims to prevent shingles in adults aged 40 and above. With the drug clinical trial approval from the National Medical Products Administration, REC610 is set for Phase I and Phase III clinical trials in China. The upcoming randomized, double-blind, parallel-controlled Phase I clinical trial will involve 180 healthy adult subjects aged 40 and above to assess the safety, tolerability, and immunogenicity of REC610. Given the strong demand for import substitution, REC610 holds promise as a significant addition to the shingles vaccine landscape in China.
Source: prnasia.com
