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A Phase 1 First-in-Human Study (B4901001) Evaluating a Novel Anti-IgE Vaccine in Adult Subjects with Allergic Rhinitis
Methods This was a randomized within cohort (total planned n=189 subjects), double-blinded, placebo controlled, dose ascending study to evaluate the safety, tolerability, immunogenicity and exploratory pharmacodynamic responses of the vaccine antigens (6, 20, 60 or 200 μg total) combined with fixed...
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Published in: | Journal of allergy and clinical immunology 2016-02, Vol.137 (2), p.AB164-AB164 |
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Main Authors: | , , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Online Access: | Get full text |
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Summary: | Methods This was a randomized within cohort (total planned n=189 subjects), double-blinded, placebo controlled, dose ascending study to evaluate the safety, tolerability, immunogenicity and exploratory pharmacodynamic responses of the vaccine antigens (6, 20, 60 or 200 μg total) combined with fixed adjuvant doses of either aluminum hydroxide (0.5 mg) [IGE-1, PF-06444753] or aluminum hydroxide plus TLR9 agonist CpG 24555 (0.5 mg each) [IGE-2, PF-06444752]. |
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ISSN: | 0091-6749 1097-6825 |
DOI: | 10.1016/j.jaci.2015.12.670 |