Abogen Biosciences Launches Phase II Clinical Trial of Lyophilized mRNA Vaccine for Shingles
Abogen
Nucleic Acid Drug Developer
Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows,Abogen Biosciences / Abogen(Shanghai)Evaluation of Limited Company in Subjects Aged 40 Years and AboveLyophilized Herpes Zoster mRNA VaccineRandomized, Double-Blind, Placebo-Controlled Study of Immunogenicity and SafetyPhase II Clinical TrialInitiated. Clinical trial registration number isCTR20254264The initial public disclosure date is November 10, 2025.
The drug formulation is a freeze-dried preparation for injection, with a specification of 0.5ml per vial after reconstitution. The method of administration is intramuscular injection, and the dosage is 0.5ml per dose, administered in 2 doses.(Interval of 60 days)The main purpose of this trial is to evaluate the immunogenicity within 30 days after receiving two doses of the experimental vaccine.
Lyophilized Herpes Zoster mRNA Vaccine is a biologic product, indicated for the prevention of herpes zoster caused by the varicella-zoster virus. Herpes zoster is caused by the reactivation of the varicella-zoster virus, presenting as clustered blisters on one side of the body, accompanied by significant pain. Diagnosis is mainly based on typical symptoms, and treatment primarily involves antiviral and analgesic therapies.
The primary endpoint indicators of this trial include the GMC, GMI, positive rate, and seroconversion rate of anti-gE antibodies at 14 days and 30 days after the second dose; the GMC, GMI, positive rate, and seroconversion rate of anti-VZV antibodies; gE-specific T cells.(Secrete IFN-γ, IL-2 T cells)Reaction(ELISpot Method); gE-specific CD4+ and CD8+ T cells express activation markers（IFN - γ、IL - 2、TNFα、CD40L）Frequency(ICS Method)Secondary endpoint indicators include the incidence of solicited adverse events and adverse reactions within 0-14 days after each dose; the incidence of unsolicited adverse events and adverse reactions within 0-30 days after each dose; and serious adverse events from the first dose to 12 months after the last dose.（SAE）And pay special attention to adverse events（AESI）Incidence Rate.
Currently, the trial status isIn Progress(Not yet recruiting), Target Enrollment300 people。
