Safety and Immunogenicity of CJCV2 With and Without ALFQ

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

January 2, 2025

Study Completion Date

January 2, 2025

Conditions
Campylobacter Infection
Interventions
DRUG

ALFQ

ALFQ (Army Liposome Formulation containing QS-21) is composed of ALF55 (cGMP-manufactured Army Liposome Formulation), QS-21 (purified extracted saponin), and Sorensen's Phosphate Buffer. Full dose of AFLQ compromised of 200 microgram 3D-PHAD and 100 microgram QS-21, co-administered with main intervention.

BIOLOGICAL

CJCV2

Vaccine comprised of C. jejuni capsule conjugated to Cross-Reactive Material 197 (CRM197), a non-toxic mutant protein of diphtheria toxin. CJCV2 will be reconstituted in 1 mL of sterile water for injection (SWI). The resuspended CJCV2 product will be diluted with sterile 0.9% Sodium Chloride for Injection. 3 dosages for administration: 1 microgram, 3 micrograms, and 10 micrograms.

Trial Locations (1)

45229-3039

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH