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CJCV2 Vaccine for Campylobacteriosis
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have a history of inflammatory bowel disease.I have not received blood products, except for Rho D Ig, in the last 90 days.I haven't had, nor plan to have, a live vaccine around the time of the trial vaccinations.I have a history of inflammatory arthritis like rheumatoid arthritis.I haven't taken any immune system altering drugs in the last 90 days.I am of childbearing age and have a negative pregnancy test.I have a history of immune system problems due to genetics, illness, or treatment.I can follow the study's procedures and attend all required visits.I am between 18 and 50 years old and not pregnant or breastfeeding.I have not been in a Campylobacter study or vaccinated against it in the last 3 years.I have used birth control for over 30 days and will continue for the study.I have received or will receive a flu or COVID-19 vaccine around my study vaccinations.I have not taken steroids or high-dose inhaled corticosteroids in the last 14 days.
- Group 1: Group 2B
- Group 2: Group 3A
- Group 3: Group 2A
- Group 4: Group 1B
- Group 5: Group 1A
- Group 6: Group 3B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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