ABO Therapeutics Launches Phase II Clinical Trial of ABO1105B mRNA Vaccine for Prevention of RSV-Associated Lower Respiratory Tract Disease

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a randomized, blinded, placebo-controlled Phase II clinical trial has been initiated to evaluate the immunogenicity and safety of a freeze-dried Respiratory Syncytial Virus (RSV) mRNA vaccine in subjects aged 50 years and above. The trial is conducted by Abogen Biosciences, Abogen (Shanghai) Biotechnologies Co., Ltd., and Abogen (Shanghai) Biotechnologies Co., Ltd. The clinical trial registration number is CTR20253567, with the initial information disclosure date on September 10, 2025.

The drug formulation is a freeze-dried preparation for injection, administered via intramuscular injection, with a dosage of 0.5ml per dose, and the treatment duration involves a single dose administration. The primary objective of this trial is to evaluate the immunogenicity at 14 days and 30 days post-vaccination.

ABO1105B is a biologic product, indicated for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection. RSV infection is a common respiratory illness that can cause symptoms such as coughing, fever, and wheezing, and may lead to severe lower respiratory tract infections when serious. Diagnosis primarily relies on viral testing.

The primary endpoint indicators of this trial include the GMT, GMI, and seroconversion rate of RSV-A and RSV-B neutralizing antibodies 14 days and 30 days after vaccination; secondary endpoint indicators have not been filled in yet.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 420 participants.

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Editor: Xiaolang Express