CompletedPhase 1

Safety and Immunogenicity of CJCV2 With and Without ALFQ

United States59 participantsStarted 2022-09-13

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide informed consent prior to initiation of any study procedures.
✓. Able to understand and comply with planned study procedures and be available for all study visits/safety communications.
✓. Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment.
✓. In general, good health\* to be safely enrolled in this study as determined by medical history, medication use\*\*, and physical exam.

Exclusion criteria

✕. Oral temperature is less than 100.4 degrees F.
✕. Pulse is 50 to 100 beats per minute (bpm), inclusive.
✕. Systolic blood pressure (BP) is 90 to 140 mmHg, inclusive.
✕. Diastolic BP is 55 to 90 mmHg, inclusive.
✕. Body Mass Index(BMI) less than 40.
✕0. Females of childbearing potential\* may enroll if subject has practiced adequate contraception\*\* \> 30 days prior to enrollment and agrees to continue adequate contraception for the entire study.

What they're measuring

Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination

Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64

Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination

Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64

Number and Percentage of Participants With Vaccine-related Unsolicited AEs Through 28 Days Post Last Vaccination

Timeframe: Day 1 through Day 85

Number and Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With Medically Attended Adverse Events (MAAEs) From First Study Vaccination Through End of Study Participation

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With New-onset Chronic Medical Conditions (NOCMCs) From First Study Vaccination Through End of Study Participation

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With Potentially Immune-mediated Medical Conditions (PIMMCs) From First Study Vaccination Through End of Study Participation

Trial details

NCT IDNCT05500417

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-01-02

Results submitted2025-12-26

View on ClinicalTrials.gov More Campylobacter Infection trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide informed consent prior to initiation of any study procedures.
✓. Able to understand and comply with planned study procedures and be available for all study visits/safety communications.
✓. Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment.
✓. In general, good health\* to be safely enrolled in this study as determined by medical history, medication use\*\*, and physical exam.

Exclusion criteria

✕. Oral temperature is less than 100.4 degrees F.
✕. Pulse is 50 to 100 beats per minute (bpm), inclusive.
✕. Systolic blood pressure (BP) is 90 to 140 mmHg, inclusive.
✕. Diastolic BP is 55 to 90 mmHg, inclusive.
✕. Body Mass Index(BMI) less than 40.
✕0. Females of childbearing potential\* may enroll if subject has practiced adequate contraception\*\* \> 30 days prior to enrollment and agrees to continue adequate contraception for the entire study.

What they're measuring

Number and Percentage of Participants With Solicited Local Adverse Events (AEs) Through 7 Days After Each Study Vaccination

Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64

Number and Percentage of Participants With Solicited Systemic Adverse Events (AEs) Through 7 Days After Each Study Vaccination

Timeframe: Days 1 through 8, Days 29 through 36, and Days 57 through 64

Number and Percentage of Participants With Vaccine-related Unsolicited AEs Through 28 Days Post Last Vaccination

Timeframe: Day 1 through Day 85

Number and Percentage of Participants With Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With Medically Attended Adverse Events (MAAEs) From First Study Vaccination Through End of Study Participation

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With New-onset Chronic Medical Conditions (NOCMCs) From First Study Vaccination Through End of Study Participation

Timeframe: Day 1 through Day 420

Number and Percentage of Participants With Potentially Immune-mediated Medical Conditions (PIMMCs) From First Study Vaccination Through End of Study Participation