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Cancer Vaccine

CampETEC HBC group for Healthy Subjects

Phase 1
Waitlist Available
Led By Kawsar R Talaat, MD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult between 18 and 50 years of age, inclusive.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 144 hours of challenge
Awards & highlights

Study Summary

This trial tests if antibodies from cows can provide protection against a type of diarrhea caused by bacteria. It will assess the safety and effectiveness of the antibodies.

Who is the study for?
This trial is for healthy adults aged 18-50 who are in good health, can attend all follow-up visits, and understand the study's requirements. Women of childbearing age must not be pregnant and agree to use birth control during the study.Check my eligibility
What is being tested?
The trial tests CampETEC HBC product and ProMilk 85 against a C. jejuni strain to see if they're safe and can prevent severe diarrhea by providing passive protection through antibodies.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort or allergic reactions due to bovine immunoglobulins but will be closely monitored for safety.

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 144 hours of challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 144 hours of challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events
Number of participants with campylobacteriosis patterns

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CampETEC HBC groupExperimental Treatment2 Interventions
CampETEC HBC (hyper immune bovine colostrum) and challenge strain C. jejuni CG8421
Group II: Placebo ProMilk 85 groupPlacebo Group2 Interventions
ProMilk 85 (placebo) and challenge strain C.jejuni CG8421

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Naval Medical Research CenterFED
33 Previous Clinical Trials
2,870 Total Patients Enrolled
Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,900 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,164 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available slots for enrollment into this trial?

"Affirmative, the information available on clinicaltrials.gov notes that this medical trial is in progress and actively seeking participants. The study was first shared online on December 1st of 2023 and recently updated to reflect their needs for 30 patients over one site location."

Answered by AI

Is the CampETEC HBC group accepted by the FDA?

"Our experts have evaluated the safety of CampETEC HBC group to be 1 due to its Phase 1 status. This indicates that there is limited evidence supporting its efficacy and safety."

Answered by AI

Is it possible to join this investigation?

"This research study is seeking 30 individuals who are in good health and aged between 18 to 50. All participants must meet these criteria before being accepted into the trial."

Answered by AI

What is the cumulative amount of individuals participating in this research endeavor?

"Correct. Documentation on clinicaltrials.gov affirms that this experiment, which was originally published on December 1st 2023, is now actively recruiting participants. 30 patients are required from a single medical site in order to complete the trial."

Answered by AI

Is the age limit of this research endeavor greater than 40 years?

"This study only welcomes participants aged 18 to 50. However, there are 62 trials available for minors and 395 studies open to those over the age of 65."

Answered by AI
~10 spots leftby Jul 2024