Vaccine Development

The complex process of vaccine development requires the execution of time-sensitive processes and an in-depth understanding of regulatory requirements to ensure the vaccine's viability and success in the marketplace. Southern Research leverages our extensive scientific expertise and knowledge to assist our government and commercial clients in the preclinical development of promising vaccines and therapeutics. Cognizant of the vital role of animal models in the product development process, scientists in the Southern Research Infectious Disease program have established a variety of model systems to support preclinical vaccine studies for influenza, HIV/AIDS, SARS, Smallpox, and RSV; in addition, we support preclinical vaccine studies for a comprehensive range of other NIAID Category A-C pathogens. Our lead scientists have gained extensive experience in vaccine strategies, including live attenuated, peptide-based, adjuvanted subunit protein, plasmid DNA, virus vector, and cell-based vaccines.

Utilizing our comprehensive, in-house in vitro and in vivo capabilities, our experienced scientists work closely with clients in providing expert guidance and advice during all phases of preclinical development. A key hallmark of our program is our capability to provide custom-designed assays and studies to meet our clients' specific research needs. In addition, we offer extensive capabilities and expertise in animal model development, and we can work closely with clients in developing any model necessary for the evaluation of vaccines and therapeutics. Our study directors are well-versed in FDA requirements for regulatory submission, and we have extensive expertise in designing IND-enabling, GLP-compliant studies that meet requirements of the FDA 'Animal Rule' where applicable. Our program is licensed by the CDC and is designated as an APHIS Select Agent Laboratory. Southern Research is an AAALAC- and USDA-accredited facility.

Our comprehensive and diverse infectious disease vaccine development capabilities include the following:

Efficacy Models

• Protocol development
• Animal procurement from approved vendors
• Vaccine evaluation studies
• Safety
• Immunogenicity via multiple immunization routes
• Dose-ranging and correlates of protection
• Challenge dose preparation and optimization via parenteral and respiratory routes, including aerosol delivery
• Clinical trial support
• BSL-2 and BSL-3 containment
• Statistical plan

Core Support Services

• Wide range of immunological and virological assays to assess humoral and cell-mediated immune responses following vaccination and/or challenge, including:
• Antibody detection by ELISA and Western blots
• Fine analysis of antibody responses using synthetic peptides to identify linear immunogenic B-cell epitopes
• Assess functionality of binding antibodies using a variety of neutralization assays, including Infectivity, Plaque Reduction Neutralization Test, Hemagglutination Inhibition, Microneutralization and Toxin Neutralization Assays
• Immunophenotyping and detection of activation markers by flow cytometry radioactive and non-radioactive-based proliferation assays
• T-cell epitope mapping
• Detecting Th1 and Th2 cytokine profiles in T-lymphoctyes subsets by intracellular flow cytometry, ELISPOT, ELISA, and multiplexing techniques
• State-of-the-art tetramer technology using MHC/peptide tetrameric complexes to directly measure CD8+ cytotoxic T-lymphocytes (CTL)
• Studies on apoptosis
• Assays to detect early signal events during T-cell activation, e.g., Calcium Mobilization Assay
• Determination of viral and bacterial loads by qRT-PCR and infectivity assays, e.g., plaque, tissue, and egg culture assays

Other Support Services

• Full-service clinical pathology and anatomic pathology
• GLP toxicology and bioanalytical sciences (BAS)
• Toxicokinetics and pharmacokinetics (ADME/PK)
• Assay development
• Quality assurance

Available Animal Models for NIAID Category A-C Pathogens

• Tuberculosis aerosol (acute and latent) - mouse
• Smallpox - monkeypox, vaccinia, and rabbitpox virus in nonhuman primate (NHP), mouse and rabbit models, respectively
• Human or Simian immunodeficiency virus (HIV and SIV)/SHIV NHP
• Influenza (pandemic and epidemic) - ferret and mouse
• West Nile virus - mouse
• Yellow fever virus - hamster and mouse
• Tularemia - mouse
• Severe acute respiratory syndrome coronavirus (SARS-CoV) - ferret
• Venezuelan equine encephalitis virus (VEE) - guinea pig and mouse
• Western equine encephalitis (WEE) - mouse
• Hantaan virus - mouse
• Anthrax - NHP, mouse, and rabbit
• Inhalational anthrax - mouse and rabbit
• Plague - mouse
• Dengue fever virus - NHP
• Respiratory syncytial virus (RSV) - cotton rat and mouse
• Intestinal - mouse
• Colitis - hamster and mouse
• Others available upon request