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Defining Correlates of Protection for the Evaluation of Immune Responses to Bacterial Pathogens

Defining Correlates of Protection for the Evaluation of Immune Responses to Bacterial Pathogens. Sandra Romero-Steiner, Ph.D. Immunology Methods Development Laboratory, Immunology Section Meningitis and Vaccine Preventable Diseases Branch. Laboratory Goal.

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Defining Correlates of Protection for the Evaluation of Immune Responses to Bacterial Pathogens

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  1. Defining Correlates of Protection for the Evaluation of Immune Responses to Bacterial Pathogens Sandra Romero-Steiner, Ph.D. Immunology Methods Development Laboratory, Immunology Section Meningitis and Vaccine Preventable Diseases Branch

  2. Laboratory Goal Define correlates of protection that can be used in the evaluation of vaccine induced responses to Streptococcus pneumoniae, Haemophilus influenzae, Neisseria meningitidis, and other bacterial pathogens.

  3. How Correlates of Protection Fit into MVPD Branch Priorities? • Preventing meningitis, pneumonia, bacteremia caused by bacterial pathogens • Prevention in children and populations at risk • Expand global access of vaccines • Expand serological diagnosis of these agents

  4. Why Study Correlates of Protection? • Identify laboratory correlates of protection • Facilitate vaccine evaluation and licensure • Optimize vaccine regimens • Determine minimum levels of protection

  5. ELISA anti-PRP Abs (RABA) 0 0.15 1.0 mg/ml Full Long-term Protection Laboratory Correlates of Protection Haemophilus influenzae type b Bioassay (SBA) Fothergill, 1933 Kaythy, 1983 Adapted from Carlone et al. Manual of Clinical Laboratory Immunology, Ch 53, 1997

  6. Implementation of Hib Correlates • PRP-T Hib fractional doses • Ab levels for prevention of Hib colonization • Hib elimination in AK • Hia ELISA, SBA and antigenicity • Non-typable Haemophilus

  7. CR1/CR3 Fcg R Bacteria Ab + C3b/iC3b PMN Laboratory Correlates of Protection Streptococcus pneumoniae Opsonophagocytosis (OPA titer = 8) ELISA IgG (0.2 mg/ml) Ab Avidity

  8. Implementation of Pnc Correlates • High risks groups (elderly, SCD, splenectomy, HIV) • Multilaboratory evaluation of OPA • Multivalent viability OPA • Functional assay for anti-PsaA Abs

  9. VS NVS Competition InteractionsPneumococcal vaccine and non-vaccine serotypes

  10. Inhibition of adherence • Anti-PsaA Abs • ELISA correlation • In vivo protection • Capsular effect • Strain variability • rPsaA effect • Receptor analysis • Target cells

  11. Pneumococcal PsaA and related peptides A B

  12. Opsonophagocytosis ELISA IgG Ab Avidity Laboratory Correlates of Protection Neisseria meningitidis Serum Bacteriocidal Activity

  13. Implementation of Men Correlates • Development and validation of improved SBA assays (fluorometric assay)

  14. Hib Pnc Men BMC, MA Robert Reid Cabral, DR Sao Paulo, Brasil Frankfurt, Germany Temuco Hospital, Chile Reykjavik, Iceland NIBSC, England KTL-Finland SKB-Belgium Aventis, Canada Aventis Pasteur, PA Wyeth Lederle, NY AIP, CDC -AK FDA WHO/PAHO Dana Farber Cancer Inst. Univ. of Rochester Louisiana State Univ. Med. College of Ohio Emory University Univ. of Miami Univ. of Pennsylvania Univ. of Minnesota VAMC, Houston Implementation of Correlates New Zeeland Gambia KEMRI, Kenya DSH, Bangladesh Johns Hopkins U. UNAM, Mexico NIH

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