From Immunogenicity to Impact: How Southern Research Helps Vaccine Developers Build Confidence Before the Clinic
Preclinical vaccine development is where promise is either clarified or quietly derailed. Long before a candidate reaches the clinic, sponsors must demonstrate not just immune activation, but meaningful protection in models that accurately reflect human disease. That distinction is where many programs succeed or struggle.
At Southern Research, vaccine development is approached through a connected system: immunogenicity, challenge studies, immune profiling, and toxicology working together to answer one essential question: does this vaccine truly protect?
Establishing the Right Foundation in Preclinical Vaccine Development
Every successful program begins with selecting the correct subject model. “You have to ensure the model is permissive to the challenge virus,” Dr. Jennifer Pickens, Director of Study Management and Infectious Disease Research, explains. That includes using both small and large subjects where appropriate and defining endpoints that matter, such as survival, weight loss, fever, viral load, and clinical scoring.
Without that foundation, even strong immune signals can fail to translate into regulatory confidence.
Immunogenicity as the First, but Not Final, Milestone
Immunogenicity data often represent the first major inflection point in a vaccine program. Southern Research designs studies to answer not only whether an immune response exists, but how it develops over time. Prime-boost strategies, single-dose regimens, and dose-sparing approaches are evaluated alongside serum and cellular responses.
Neutralizing antibodies and T-cell responses are tracked as early indicators, but always with a clear understanding that immunogenicity alone is not proof of protection.
Why Challenge Studies Are the True Test
Challenge studies transform immune signals into biological truth. “If you can demonstrate protection against severe disease in a robust model, that tells a very clear story,” says Dr. Pickens. Model selection is critical, with ferrets often used for transmission studies, while other well-characterized models enable clear differentiation of efficacy under conditions of significant disease burden, alongside endpoints designed to closely reflect human infection.
Southern Research’s ability to pair well-characterized viral strains with qualified animal models allows sponsors to move efficiently from signal detection to functional proof.
Correlates of Protection and Regulatory Readiness
Correlates of protection define the threshold where immunity becomes meaningful. Rather than relying on a single number, Southern Research evaluates ranges of immune response tied to real-world outcomes, reduced viral replication, improved survival, or mitigated symptoms.
By integrating immunogenicity data, challenge outcomes, immune profiling, and toxicology into a cohesive narrative, Southern Research helps sponsors present regulators with a complete, defensible package, reducing downstream questions and delays.
A Partner Focused on Shepherding Programs Forward
Southern Research’s approach is shaped by decades of federally funded vaccine development and biodefense work. “We shepherd test articles into the clinic,” Dr. Pickens says. “That’s our purpose.”
From early go/no-go decisions through IND-enabling studies, Southern Research serves as both scientific executor and strategic partner, helping vaccine developers move forward with clarity, confidence, and credibility.