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Clinical Trials associated with Campylobacter jejuni Conjugate Vaccine(National Institute of Allergy and Infectious Diseases)First-in-Human Safety and Immunogenicity Evaluation of an Intramuscular Campylobacter Jejuni Conjugate Vaccine (CJCV2) With and Without Army Liposome Formulation Containing QS-21 (ALFQ)
This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21). Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.
100 Clinical Results associated with Campylobacter jejuni Conjugate Vaccine(National Institute of Allergy and Infectious Diseases)
100 Translational Medicine associated with Campylobacter jejuni Conjugate Vaccine(National Institute of Allergy and Infectious Diseases)
100 Patents (Medical) associated with Campylobacter jejuni Conjugate Vaccine(National Institute of Allergy and Infectious Diseases)
100 Deals associated with Campylobacter jejuni Conjugate Vaccine(National Institute of Allergy and Infectious Diseases)