Campylobacter Infection Clinical Trial
Official title:
Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)
The purpose of this study is to assess the safety of increasing doses of a potential vaccine against Campylobacter with and without Alhydrogel®, an aluminum hydroxide adjuvant. This study will also assess immune responses induced by the vaccine.
This is an open-label, dose-escalating study in which a total of 48 healthy volunteers will
receive 2 vaccinations (one on Day 0 and one on Day 28 ± 2 days).
There are 3 cohorts (dose levels) with 2 groups of 8 volunteers in each cohort. A cohort will
be administered one of 3 intramuscular (IM) doses at 2 μg, 5 μg, or 10 μg of
Capsule-Conjugate Campylobacter Vaccine (CJCV1) with or without Alhydrogel®, aluminum
hydroxide adjuvant (alum) at 125 μg.
An interval no less than 1 week will separate the last dose of a volunteer group from the
first dose of the next volunteer group (receiving different CJCV1 doses). Blood specimens
will be collected at intervals to examine systemic and mucosal antigen-specific immune
responses. Vaccine safety will be actively monitored during vaccination and for 28 days (± 2
days) following the second vaccination and complete the study with a telephone follow-up
approximately 6 months (± 1 month) after the first vaccination. The total duration of
participation in this study is up to 270 days (including screening).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05500417 -
Safety and Immunogenicity of CJCV2 With and Without ALFQ
|
Phase 1 | |
| Active, not recruiting |
NCT00859716 -
ACE393-103 Vaccination Challenge Study
|
Phase 2 |