SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the efficacy of existing vaccines, particularly in vulnerable populations.
Study Design and Objectives
The study, a randomized, open-label Phase I trial, is designed to assess the safety and tolerability of different doses of thymalfasin as an immune response enhancer prior to COVID-19 mRNA vaccination. The primary objective is to evaluate the safety and tolerability of thymalfasin when administered before the inoculation of COVID-19 mRNA vaccines (such as Moderna or Pfizer). Secondary objectives include exploring immunogenicity indicators related to treatment, such as levels of neutralizing and non-neutralizing antibodies, neutralizing activity, and T cell response. The study will be conducted under the leadership of Houston Methodist Hospital in the United States.
Focus on Elderly Population
The study comes in response to the recognized need for enhanced vaccine efficacy in elderly individuals, aged 65 and above, who typically exhibit lower immunogenicity and efficacy against various vaccines compared to younger individuals. Immunosenescence and inflammaging are believed to contribute to poor immunogenic responses in this demographic. Thymalfasin, a classic immune regulator used in clinical practice, plays a crucial role in both the natural and adaptive immune systems. Research suggests that thymalfasin can improve the response of elderly and immunocompromised patients to various vaccines, potentially offering a valuable tool in the ongoing fight against COVID-19.-Fineline Info & Tech
