At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Capsule-Conjugate Campylobacter Vaccine (CJCV1) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1)
U.S. Army Medical Research and Development Command·interventional·Posted Feb 20, 2014·Updated Feb 23, 2018
In Brief
A Phase 1 clinical trial evaluating Capsule-Conjugate Campylobacter Vaccine (CJCV1) and Alhydrogel®, aluminum hydroxide adjuvant (alum) for Campylobacter Infection. Completed, enrolled 48 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCampylobacter Infection
CountriesUnited States
CollaboratorsWalter Reed Army Institute of Research (WRAIR)
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartApr 2014
Primary CompletionSep 2014
Study CompletionJan 2016
TodayJul 2026
First PostedFeb 20, 2014
Enrollment StartApr 21, 2014
Primary CompletionSep 24, 2014
Study CompletionJan 22, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.4 years ago
Interventions
Capsule-Conjugate Campylobacter Vaccine (CJCV1)biological
The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
Alhydrogel®, aluminum hydroxide adjuvant (alum)drug