China-based Jiangsu Recbio Technology has announced positive results from a first-in-human (FIH) trial of a shingles vaccine.
The trial compared REC610, a novel adjuvanted recombinant shingles vaccine, against GSK’s Shingrix. REC610 promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies and is intended to prevent shingles in adults aged 40 and above.
The randomised, quadruple blind, prevention, active-controlled Phase I trial (NCT05769049) enrolled an estimated 48 patients in the Philippines.
Interim Phase I results
Interim results showed that REC610 demonstrated an overall favourable safety and tolerability profile in healthy participants aged 40 years and above after two doses of the vaccination.
No serious adverse events (SAEs), adverse events of special interest (AESI) or treatment-emergent adverse events (TEAEs) leading to early discontinuation were reported.
Vaccine-related TEAEs, solicited local and systemic TEAEs, and unsolicited TEAEs were comparable between both groups. Most vaccine-related TEAEs were Grade 1 or Grade 2, and all recovered between one and three days post-vaccination. The common TEAEs in the REC610 group included injection site pain, injection site swelling, pyrexia, headache, and myalgia.
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Both groups, REC610 and Shingrix, induced high levels of gE-specific antibodies at 60 days after the first dose vaccination, and 30 days after the second dose vaccination.
Humoral and cellular immune responses were comparable between the REC610 and Shingrix groups, and the immune response level in the REC610 group was numerically higher than that in the Shingrix group.
Trial approval in China
The candidate received a clinical trial approval notice issued by the National Medical Products Administration (NMPA) in China in October 2023.
Jiangsu Recbio Technology will also run a randomised, double-blind, parallel-controlled Phase I trial in 180 healthy adult subjects aged 40 years and above in China to evaluate the safety, tolerability and immunogenicity of REC610.
The only marketed shingles vaccine in China is GSK’s Shingrix.
According to GlobalData’s Pharmaceutical Intelligence Centre, there is one ongoing Phase I trial and one planned Phase I trial of the candidate. GlobalData is the parent company of the Clinical Trials Arena.