Development, Pre-Clinical Safety, and Immune Profile of RENOVAC-A Dimer RBD-Based Anti-Coronavirus Subunit Vaccine

Area of Science:

• Vaccinology
• Immunology
• Preclinical Research

Background:

• Vaccine development is crucial for infectious disease control, particularly in developing nations.
• Evaluating vaccine safety and immunogenicity is key to global health security.
• Existing COVID-19 vaccines highlight the need for robust development platforms.

Purpose of the Study:

• To develop and assess the safety and immunogenicity of a novel local subunit vaccine candidate, RENOVAC.
• To evaluate RENOVAC's toxicity and immune response profile in preclinical animal models.

Main Methods:

• A synthetic gene encoding a tandem receptor-binding domain (RBD) with a GS linker was cloned and expressed in CHO cells.
• The purified protein was formulated into 10 µg/dose and 25 µg/dose vaccines for toxicity and immunogenicity testing.
• Sprague Dawley rats received intramuscular injections to assess 14-day repeated dose toxicity and immune responses.

Main Results:

• RENOVAC was well-tolerated at doses up to 25 µg/animal, with no significant adverse toxicological findings.
• The vaccine induced high levels of specific immunoglobulins (IGs) and neutralization antibodies (NAbs).
• Immune responses involved CD4+ Th2-cell activation, leading to B-cell activation and humoral immunity.

Conclusions:

• RENOVAC exhibits acceptable safety and reliable immunogenicity in preclinical studies.
• The vaccine's profile supports its advancement into clinical trials for further evaluation.
• This study contributes to developing effective vaccine platforms for enhanced health security.