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Conjugate Vaccine

CJCV2 Vaccine for Campylobacteriosis

Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 through day 113
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new vaccine for Campylobacter jejuni, a common cause of food poisoning. The vaccine will be given as a shot, and people will be randomly assigned to receive either the vaccine alone or the vaccine plus an adjuvant (a substance that helps increase the effectiveness of the vaccine). The primary objective is to evaluate the safety of the vaccine, and the study hypothesis is that the vaccine will be safe and effective.

Who is the study for?
This trial is for healthy adults aged 18-50 who can consent to study procedures, are not pregnant or breastfeeding, have a BMI under 40, and agree to use contraception. They must be in good health with stable blood pressure and temperature, not on certain medications or drugs, and without recent vaccinations or immunizations.Check my eligibility
What is being tested?
The trial tests the safety and immune response of three doses (1 ug, 3 ug, and 10 ug) of CJCV2 vaccine against Campylobacter jejuni infection. It's given with/without ALFQ adjuvant over three intramuscular shots spaced by 28 days. Participants are grouped into cohorts to compare different dosages.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general symptoms such as fever or fatigue after vaccination. Since it's a test for safety too, monitoring will capture any unexpected adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old and not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 through day 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 through day 113 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Medically-Attended Adverse Events (MAAE)
Occurrence of New-Onset Chronic Medical Conditions (NOCMC)
Occurrence of Potentially Immune-Mediated Medical Conditions (PIMMC)
+4 more
Secondary outcome measures
Immunoglobulin G
Immunoglobulin G
Immunoglobulin G

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 3BExperimental Treatment2 Interventions
Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10
Group II: Group 3AExperimental Treatment1 Intervention
Each subject will receive a 1 mL intramuscular (IM) injection containing 10 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10
Group III: Group 2BExperimental Treatment2 Interventions
Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10
Group IV: Group 2AExperimental Treatment1 Intervention
Each subject will receive a 1 mL intramuscular (IM) injection containing 3 micrograms of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10
Group V: Group 1BExperimental Treatment2 Interventions
Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) and a full dose of Army Liposome Formulation containing QS-21 (ALFQ) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10
Group VI: Group 1AExperimental Treatment1 Intervention
Each subject will receive a 1 mL intramuscular (IM) injection containing 1 microgram of Campylobacter jejuni Conjugate Vaccine 2 (CJCV2) on Days 1, 29, and 57. 3 sentinel subject will be dosed first; if no safety signals are noted within 7 days after sentinel dosing, the remaining 7 subjects will be dosed. N=10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,266 Previous Clinical Trials
5,484,037 Total Patients Enrolled

Media Library

CJCV2 (Conjugate Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05500417 — Phase 1
Campylobacteriosis Research Study Groups: Group 2B, Group 3A, Group 2A, Group 1B, Group 1A, Group 3B
Campylobacteriosis Clinical Trial 2023: CJCV2 Highlights & Side Effects. Trial Name: NCT05500417 — Phase 1
CJCV2 (Conjugate Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05500417 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program recruiting participants aged 85 or above?

"The eligibility criteria for this trial necessitate that participants are between the ages of 18 and 50."

Answered by AI

How many persons have enrolled in this experiment?

"Affirmative, the records on clinicaltrials.gov demonstrate that this experiment is actively looking for participants. The study was launched on August 22nd 2022 and last amended on August 25th 2022; it seeks to enrol 60 individuals at a single site."

Answered by AI

Might I be qualified to partake in this medical trial?

"Candidates between 18 and 50 years old with a campylobacter infection have the opportunity to participate in this medical trial. The research team is aiming for 60 participants total."

Answered by AI

Are there any potential risks associated with CJCV2 for patients?

"Our assessment of CJCV2's safety was a 1 since this is an initial Phase 1 study. This implies that there exists limited supportive evidence for the treatment’s efficacy and security."

Answered by AI

Are any new participants being accepted into this research project currently?

"This trial is currently recruiting participants, as indicated by the clinicaltrials.gov webpage that was initially uploaded on August 22nd 2022 and revised three days later."

Answered by AI
~10 spots leftby Aug 2024