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Peptide-based GAS Vaccine for Streptococcal Infections
Study Summary
This trial is to study how safe and effective two different types of vaccine are against strep A infection in healthy adults.
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?
Media Library
- I am up to date with my flu and COVID-19 vaccines.You have been diagnosed with severe mental health conditions like schizophrenia or bipolar disorder that significantly affect your daily life.I have previously used appetite suppressants like phentermine or Fen-Phen.I haven't needed antibiotics for a serious infection in the last 14 days.You have had an allergic reaction to a vaccine that contains diphtheria toxoid or CRM197.I have a serious heart valve condition.My heart's pumping ability is reduced, or it's enlarged.I have significant heart valve issues or high blood pressure in the lungs.I do not have major birth-related heart issues, except for a common hole in my heart.I have a weak immune system and have been on strong medication for it in the last 3 years.I am taking psychiatric medication and have been stable for at least 3 months.I plan to stay in the area for the next 10 months and won't travel abroad for 30 days after the last vaccine dose.I have received blood or blood products in the last 3 months.I have not received vaccines (except flu and COVID-19) 30 days before or plan to until 30 days after the study.I have had a recent strep infection, confirmed by high anti-streptolysin O or anti-DNase B levels.I have a genetic condition like Down's syndrome.You or someone in your family has had a type of disease caused by streptococcus bacteria or a condition called collagen-vascular disease.I have been diagnosed with rheumatic heart disease or acute rheumatic fever.I do not have serious chronic diseases like heart disease, autoimmune disorders, or diabetes.You have a history of alcohol or drug abuse in the past 5 years. However, the decision to include you in the trial will be made by the doctor based on whether they think it may affect your ability to participate and be followed up.I have a condition that causes prolonged bleeding.My risk of heart disease in the next 10 years is over 10%.I have more than a small amount of fluid around my heart.I have not had a fever or any infections in the last 5 days.I have aortic regurgitation.I have had a kidney condition following a strep infection.I have a history of leukemia, lymphoma, or other cancers.I am between 18 and 45 years old and not pregnant.You have had a serious reaction after getting vaccinated before.
- Group 1: Vaccine p*17-K4S2 (50 µg/mL) Vaccine
- Group 2: Rabavert Vaccine
- Group 3: J8-K4S2 (100 µg/mL ) Vaccine
- 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
Are elderly patients being accepted into this trial?
"The age limit for this trial is 45 years old. Any patients that young or older will not be accepted into the study."
Is J8-K4S2 a common prescription in clinical trials?
"As of right now, there are two J8-K4S2 trials underway. 0 of those active clinical trials are in the last stage before FDA approval. Most studies for J8-K4S2 take place in Edmonton, Alberta; however, there are also research sites in 2 other locations."
How many people are researchers hoping to include in this trial?
"That is accurate. The listing on clinicaltrials.gov says that the trial began recruiting on 11/7/2022 and as of right now, they are still looking for 30 individuals to fill the 1 available spot(s)."
Are investigators still enrolling participants for this research project?
"That is accurate. The clinicaltrials.gov website has information indicating that this trial is currently searching for individuals to enroll. This research was first posted on November 7th, 2020 and was last updated more recently on the same day. So far, 30 volunteers are needed from 1 location."
How can I sign up for this research project?
"This trial is seeking 30 patients with streptococcal infections aged 18 to 45. Candidates must meet the following criteria:- Be able to understand the purpose and procedures of the study, and sign an informed consent form- Be a non-smoker in good general health, as determined by medical screening including history, clinical laboratory tests, and physical examination within 28 days of the first dose- Have a normal electrocardiogram (ECG) and echocardiogram (ECHO)- Women must agree not to become pregnant during the trial. If sexually active, they must use effective birth control"
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