According to an interim analysis, healthy individuals aged 40 years and above showed an overall favourable safety and tolerability profile for REC610 following two doses of the immunisation
Jiangsu’s REC610 has showed positive response in FIH trial. (Credit: Angelo Esslinger from Pixabay)
Jiangsu Recbio Technology said that its adjuvanted recombinant shingles vaccine REC610 has shown positive results in the interim analysis of the first-in-human (FIH) clinical trial in the Philippines.
REC610 has a novel adjuvant BFA01 that promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies. It is intended to inhibit shingles in adults aged 40 years and above.
The Chinese company previously conducted a GSK Shingrix active-controlled FIH clinical study of REC610 in the Philippines.
According to an interim analysis, healthy individuals aged 40 years and above showed an overall favourable safety and tolerability profile for REC610 following two doses of the immunisation.
The asset generated strong gE-specific humoral and cellular immune responses, which were noticeable after the first immunisation and peaked 30 days after the second.
In addition, the humoral and cellular immune responses were similar between the REC610 and Shingrix groups. REC610 group’s immune response level was also numerically higher than the Shingrix group.
REC610 also had a good safety profile with the two-dose vaccination regimen with no reports of SAE, AESI, or TEAE causing an early termination.
The REC610 group and Shingrix group had similar cases of vaccination-related TEAEs, solicited local and systemic TEAEs, and unsolicited TEAEs.
Furthermore, the potential shingles vaccine induced favourable humoral and cellular immune responses in both elderly and adult groups.
In October 2023, China’s National Medical Products Administration (NMPA) approved REC610 for use as a preventative 3.3 biological product in Phase 1 and Phase 3 clinical trials being conducted in China.
In the future, Jiangsu Recbio plans to recruit 180 healthy adult participants in Mainland China who are 40 years of age or older for a Phase 1 trial to assess the safety, tolerability, and immunogenicity of adjuvanted recombinant shingles vaccine.
At present, GSK’s Shingrix, the new adjuvant recombinant vaccine, is present in the Chinese market.