Safety and Immunogenicity of CJCV2 With and Without ALFQ
Status:
Not yet recruiting
Trial end date:
2024-08-21
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)