Critical Steps for Approval of Adjuvanted Pandemic Vaccines

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1 Critical Steps for Approval of Adjuvanted Pandemic Vaccines Gary Grohmann 8th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer to Developing Country Vaccine Manufacturers March 2015, Sao Paulo, Brazil 1

2 Background Adjuvants (immune potentiators or immunomodulators) have been used for decades to improve the immune response to vaccine antigens More than one adjuvant can be used Aimed at enhancing, accelerating and prolonging the specific immune response towards the desired response to vaccine antigens Adjuvants can be employed to optimise a desired immune response: induction of cytotoxic or helper T lymphocyte responses and promote antibody responses. 2

3 3

4 Background: Adjuvant Landscape Mineral salts, e.g., aluminium hydroxide and aluminium or calcium phosphate gels. Oil emulsions and surfactant based formulations, e.g., MF59, QS21 (purified saponin), AS02 (oil-in-water emulsion + MPL + QS-21), Montanide ISA-51 and ISA-720. AS03 (oilin-water emulsion squalene, α-tocopherol, polysorbate 80) Particulate adjuvants, e.g., virosomes (unilamellar liposomal vehicles incorporating influenza haemagglutinin), AS04 (MPL, Al. phosphate) 4

5 Background: Adjuvant Landscape ISCOMS (structured complex of saponins and lipids), Microbial derivatives (natural and synthetic), e.g., monophosphoryl lipid A (MPL) Endogenous human immunomodulators, e.g., hgm-csf or hil-12 (cytokines that can be administered either as protein or plasmid encoded), Immudaptin (C3d tandem array) Inert vehicles, such as gold particles 5

6 Licensed Vaccines with Adjuvants From Nature Reviews Immunology 11, (December 2011) 6

7 Vaccine regulatory pathway Preclinical In vitro, animal immunogenicity, protection, toxicity Clinical trials (Concurrent nonclinical) Phase I Phase II Phase III healthy adults (18-50 years old) Several hundred subjects subjects to detect adverse events with incidence of 1/100-1/1000 vaccinated subjects, more for specific issues (70,000+ for Rotateq ) Registration All quality, nonclinical and clinical data evaluated for safety and efficacy Postregistration Phase IV Passive surveillance, phase IV clinical trials (booster, new population), pregnancy register, lot testing

8 Regulatory guidelines for vaccines Vaccine type Most vaccines All vaccines Vaccines for infectious disease, in pregnant women, women of childbearing potential, men Recombinant DNA protein vaccines Guideline EMA: Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95, 1997) WHO: Guidelines on nonclinical evaluation of vaccines (WHO Technical Report Series, no. 927, 2005) WHO: Guidelines on clinical evaluation of vaccines: regulatory expectations (WHO Technical Report Series, no. 924, 2004) FDA (CBER) Guidance for industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications (2006) ICH: Preclinical safety evaluation of biotechnology-derived pharmaceuticals S6(R1) (2011)

9 Regulatory Guidelines for Adjuvanted vaccines Guidelines EMA: Guideline on adjuvants in vaccines for human use (2005) Guideline on pharmaceutical and biological aspects of combined vaccines (CPMP/BWP/477/97) cell substrates (CPMP/ICH/294/95) Viral safety (CPMP/ICH/295/95), rdna proteins (CPMP/ICH/139/95). nucleic acid (CPMP/BWP/3088/99) - WHO: Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines - ICH Note for Guidance on Statistical Principles for Clinical Trials (ICH topic E9) - Points to Consider on Multiplicity Issues in Clinical Trials (CPMP/EWP/908/99)

10 Critical First Steps Be familiar with the guidelines Communicate regularly and meet with the relevant NRA Be aware of any local NRA guidelines Have a complete chemical description of the Adjuvant(s) the function of each adjuvant and/or each component should be described to the extent that it is known 10

11 Critical First Steps Proposed or actual manufacture of the adjuvant should be described in detail Special attention should be given to the source material NOTE the Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents (EMEA/410/01) DEFINE parameters that are critical in conferring the correct physical, biochemical, biological or adsorptive properties of the adjuvant Generate Stability data 11

12 Critical Steps: Pre clinical studies for adjuvanted vaccines The increased/modified immune response with the adjuvanted vaccine should be demonstrated in a relevant animal model. Toxicity studies with the adjuvant alone for adjuvants with no existing toxicology data, and/or adjuvant-only group in adjuvanted vaccine repeat-dose toxicity study. Markers of inflammation useful pivotal organs: heart, lung, brain, liver, kidney, reproductive organs, spleen, thymus, bone marrow, lymph nodes Local tolerance consider the possibility of late granulomas with particles and mineral oils Assess local and regional tolerance for intranasal, oral vaccines. If the adjuvant itself is immunogenic, tests may be indicated for hypersensitivity e.g. passive cutaneous anaphylaxis, active systemic anaphylaxis assays, IgE measures, and dermal sensitization potential. Test the adjuvant for pyrogenicity EMA. Guideline on adjuvants in vaccines for human use (2005). WHO. Guidelines on the nonclinical evaluation of vaccine adjuvants 12

13 Critical Steps: Pre clinical studies for adjuvanted vaccines Non-clinical immunogenicity data are expected Dose-response Comparative studies to assess the effect of a new adjuvant with reference to a vaccine antigen alone or adjuvanted Studies in two different animal models 13

14 Critical Steps: Clinical Studies The inclusion of an adjuvant in a vaccine must always be justified It is critical that the amount of adjuvant used in the vaccine is appropriate to enhance the immune response to the antigen(s) The studies should involve a comprehensive assessment of the potential effects of the adjuvant on the immune response to all antigens that are to be included in the final product. The potential that the adjuvant itself might be immunogenic should be explored. 14

15 Clinical Studies The assessment of the humoral immune response should include the detection and titration of functional antibodies against an international standard (WHO or equivalent). Immunoglobulin subclass responses should be investigated. It may also be appropriate to estimate other properties of the antibody response such as avidity. Assessment of the cell-mediated component of the immune response is considered important. 15

16 Dose-finding studies Generate sufficient data to demonstrate that the amounts of adjuvant and antigen that are chosen for further study represent an acceptable balance between immune responses and the risk of adverse effects these studies should be performed in the target population for the vaccine. 16

17 Clinical Trials Clinical trials should be randomised, double blind, controlled trials will likely involve only an assessment of immune responses against validated immunological correlates for protection Trials should be performed in the final target population. Conservative stopping rules for the individuals and the entire study need to be in place. 17

18 Safety The safety data should show the likely rates of reactions that may be expected based on the known properties of the adjuvant(s) and antigen(s). In some cases, it may be appropriate that the data focus on immune mediated reactions. The risk-benefit relationship for the adjuvanted product should be at least as favourable as for the non adjuvanted product. A post-marketing surveillance program should in place 18

19 Conclusions Communicate with the NRA Know the relevant guidelines and regulations Nonclinical safety assessment essential pharmacology and toxicity testing with careful biological and chemical characterization of the adjuvant and the antigen Two species Clinical studies and clinical safety assessment essential The added value of the adjuvant in the formulation be demonstrated. importance of the risk-versus-benefit assessment 19

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