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COVID-19: Correlates of Protection Workshop hosted by the Clinical Development & Operations and Enabling Sciences SWAT Teams Thursday, November 19, 2020 Agenda Time (CET) Topic Speaker(s) 15:00 – 15:05 Welcome & Meeting Objectives Peter Dull, Ivana Knezevic Session 1: Evidence for Existence of an Immune Correlate for Covid-19 15:05 – 15:20 Correlates of Vaccine-Inducted Immunity – An Overview Stanley Plotkin 15:20 – 15:40 SARS-CoV-2 immunity overview and risk factors for re-infection Florian Krammer 15:40 – 15:55 PK/PD Considerations for SARS-CoV-2 Neutralizing Antibodies Andrew Charles Adams 15:55 – 16:10 Non-human primate (NHP) passive transfer and vaccine studies Dan Barouch 16:10 – 16:50 Panel Discussion Moderated by Karen Makar Session 2: Operational, Statistical and Regulatory Considerations for Covid-19 Immune Correlates 16:50 – 17:00 Opportunities for CoP Identification from Ongoing Phase III VE Studies Kristen Earle 17:00 – 17:15 Regulatory Perspective: Approach to Acceptance of CoP for Licensure Daniel Brasseur 17:15 – 17:25 COVID-19 Immunoassay Platform Overview Richard Koup Development of the COVID-19 Research Standards and 17:25 – 17:35 Valentina Bernasconi Global Immunoassay Network 17:35 – 17:50 Statistical Approaches for Assessment of Immune Correlates of Protection Peter Gilbert 17:50 – 18:25 Panel Discussion Moderated by Peter Dull 18:25 – 18:30 Wrap Up & Next Steps Paul Kristiansen, Jakob Cramer Privileged and confidential 2 Welcome & Meeting Objectives Peter Dull Deputy Director, Integrated Clinical Vaccine Development (Bill & Melinda Gates Foundation) Ivana Knezevic Group Lead, Norms and Standards for Biologicals (WHO) 3 Context for today’s workshop • Recent positive results from large Covid-19 vaccine efficacy studies is great news but we need multiple licensed products to have the necessary near-term global impact • Complexities for operational pathways for next vaccine registration highlights the urgent need to accelerate progress toward identification of an immune correlate of protection. A correlate could: o Accelerate access to additional Covid-19 vaccines through alternative study designs o Support evaluation for durability of protection for each vaccine • There is currently limited and scattered evidence on COVID-19 immune correlates which will benefit from a consolidated review and dialogue Privileged and confidential 4 Objectives for the first half of the workshop • Review correlates nomenclature and highlight core principles in the approach to identification of immune correlates through key examples from past efforts • Present the accumulated evidence for immune responses to coronaviruses including SARS-CoV-2 • Review efforts to identify an association of re-infection risk with antecedent immune profile including an overview of ongoing and planned studies • Share available NHP mAb PrEP preclinical data dose response results as well as recent early treatment clinical data to inform contribution of targeted antibodies for protection • Review NHP dose-titration protection data from convalescent sera and vaccine studies and discuss evidence for contribution of cell-mediated immunity to protection in pre-clinical models Privileged and confidential 5 Correlates of Vaccine- Induced Immunity – An Overview Stanley Plotkin, MD Emeritus Professor of Pediatrics (University of Pennsylvania) 6 by Stanley A. Plotkin 1. Basic immunology 2. Enables correct choice of vaccine antigen 3. To permit consistency of potency 4. To determine susceptibility of an individual or a population 5. If efficacy trial not feasible or ethical, immunological data enable licensure of vaccine 6. Enables bridging from first-generation vaccine to second generation 8 Correlate of Protection (CoP): An immune response that is statistically interrelated with protection Absolute Correlate: A specific level of response highly correlated with protection: a threshold Relative Correlate: Level of response variably correlated with protection Co-Correlate: One of two or more factors that correlate with protection in alternative, additive, or synergistic ways. 9 An immune response that is responsible for protection 10 Formerly called: Surrogate: An immune response that substitutes for the true immunologic correlate of protection, which may be unknown or not easily measurable 11 1. Levels of passively administered or maternal antibody that protect 2. Analysis of immune responses in protected and unprotected subjects in efficacy trials 3. Observations made on vaccine failures, e.g. immunosuppressed individuals 4. Human challenge studies 5. Extrapolation from animal challenge studies, including immunodeficiency 12 Serum Antibody CD4+ T cells Neutralizing B cell help Non-neutralizing (ADCC, etc.) T cell help Functionality (opsonsphagocytosis) Th17) Avidity Cytokines Lysis Tregs Mucosal Antibody CD8+ T cells IgA locally produced Lysis IgG diffused from serum Avidity 13 Must Define Protection. Against what? Infection? (Local or Disseminated) Disease? (Mild or severe) 14 Protection against disease IgG serum antibodies Protection against infection IgA- IgG mucosal antibodies 15 16 ▪ T cell deficient humans suffer serious and fatal measles. ▪ Monkeys vaccinated with measles HA alone (low CD4+ T cell response) are protected against rash, but remain chronically viremic. ▪ Monkeys depleted of CD8+ T cells have increased viremia. Pan CH, PNAS, 2005 17 18 No. of pfu in challenge 10 100 1000 Group Seronegative Naturally seropositive Vaccinated seropositive Plotkin,S.A. et al. J Infect Dis 1989;159: 860-865. 19 20 21 Influenza Coudeville, L Personal communication 22 23 Age ELISA % Bactericidal % Efficacy in (years) Pos.* Pos.# Canada 1 93 18 0% 2 94 35 3 92 56 41% 4 94 75 5 84 68 Adult 100 100 83% * 2 mcg/ml # 1/8 Maslanka SE, et al. Infect Immun, 1998, 66:2453-59, DeWals P, et al. JAMA 2001 24 25 (Artificial Challenge in Children) Serum Nasal HAI lgA Shedding - - 63% - + 19% + - 15% + + 3% Belshe, JID, 2000 26 27 28 29 Varicella gE protein plus ASOI adjuvant Efficacy > 90% ▪ Vaccine boosts VZ antibody, which is used as an nCop, but mCop is VZ-specific CD4+ lymphocyte proliferation stimulation index ≥ 5.0 Hata et al. NEJM 2002 30 31 ▪ Mucus ▪ Innate immune responses ▪ Barrier to vascular entry ▪ Mucosal lgA Antibody ▪ Mucosal lgG Antibody ▪ Serum lgG Antibody ▪ T cell responses 32 ▪ Binding antibodies that prevent attachment (Ebola) ▪ Th17 that attract PMN’s and prevent carriage (pneumococcal, TB?) ▪ Antibody Dependent Cellular Cytotoxic antibody (HIV) ▪ Stimulation of CD4+ T helper cells that secrete cytokines (pertussis) 33 Jang, Y., Seong, B., Expert Opinion on Drug Discovery, 2020 34 Influenza Vaccines as Examples of Complexity of Correlates HAI titer is usually used as mCoP but Micro-neutralization and ELISA may be better HA Stalk antibodies contribute Antibodies to neuraminidase contribute ADCC antibodies do not contribute Mucosal lgA helps, at least for LAIV CD8+ T cell function important in the elderly Christensen, S., et al, JVI April 2019; Ng, S., et al, Nat Med June 2019 35 POLYTHEISM IS PREFERABLE TO MONOTHEISM 36 Evidence for Existence of a Correlate: SARS- CoV-2 immunity overview and risk factors for re- infection Florian Krammer, PhD Professor of Vaccinology (Icahn School of Medicine at Mount Sinai) 37 Evidence for Existence of a Correlate: SARS-CoV-2 immunity overview and risk factors for re-infection Florian Krammer Mount Sinai Professor in Vaccinology Icahn School of Medicine at Mount Sinai COVAX CoP Workshop November 19th, 2020 SARS-CoV-2 antigens PBD # 6VXX Grifoni et al., Cell, 2020 Potential correlates of protection: Antibody responses • Antibodies to spike/RBD are often neutralizing • Antibodies to NP, nonstructural proteins are non-neutralizing • Fc-FcR interactions have so far been shown to play a negligible role in protection • IgM and IgA seem relatively short-lived • IgG response seems normal/long-lived • Mucosal antibody is present after infection ELISA reactivity to spike protein and neutralization titers correlate N = 120 Wajnberg et al., Science, 2020 How long-lived are these antibody responses? Wajnberg et al., Science, 2020 Potential correlates of protection: Memory B cells https://www.medrxiv.org/content/10.1101/2020.08.11.20171843v2 Potential correlates of protection: T-cells CD4+ CD8+ What do we know about protection from human coronavirus (hCoV) infection? Historic challenge studies with 229E Author Type of study Virus Result Correlate Callow et al., Challenge/re- 229E Challenge: 10 of 15 infected Antibody???? 1990 challenge Re-challenge: Partial protection from reinfection, protection from symptomatic infection Callow, 1985 Challenge 229E Asymptomatic and uninfected sIgA, neutralizing antibody individuals had much higher baseline neutralizing antibody titers Reed 1984 Challenge 229E 6/6 protected from re- Antibody? challenge with homologous virus (no virus, no symptoms) Barrow 1990 Challenge 229E Lower proportion of Antibody individuals with high antibody titer experience significant colds compared to group with lower titers Adapted from Huang et al., Nature Communications, 2020 ….but: ….durability may be limited and not cross protective Is there any evidence for correlates of protection against SARS-CoV-2 infection in humans? A glimpse of evidence for protection by neutralizing antibodies from a fishing vessel • 122 individuals on the ship • 3 had neutralizing antibodies before going to sea • Outbreak with 82.5% attack rate occurred Individuals with neutralizing antibodies were not infected PARIS/SPARTA PARIS (Protection
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