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NCT05500417 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of CJCV2 With and Without ALFQ
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT05500417 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 59 participants.
The verdict
NCT05500417, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study 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.
Interventions
- DRUG ALFQ
- BIOLOGICAL CJCV2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2025-01-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05500417
The ClinicalTrials.gov registry entry for NCT05500417 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ALFQ is the first listed.
NCT05500417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05500417 about?
NCT05500417 is a clinical study titled "Safety and Immunogenicity of CJCV2 With and Without 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 (CJCV...
What is the current status of trial NCT05500417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2022-09-13. Estimated completion is 2025-01-02.
What interventions are being tested in trial NCT05500417?
The interventions under investigation include: ALFQ (DRUG), CJCV2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05500417?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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