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Cancer Vaccine
EBV Vaccine for EBV Infection
Phase 1 & 2
Recruiting
Led By Jessica R Durkee-Shock, M.D.
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights
Study Summary
This trial tests a vaccine against EBV infection. Healthy 18-22 year olds will receive either a vaccine or placebo, plus physical exams and record any side effects. Follow-ups over 2 years.
Who is the study for?
Healthy individuals aged 18 to 22 who've never had EBV infection, can consent, and commit to the study for about 18 months. They must avoid certain vaccines before/after receiving the study vaccine and use effective contraception if applicable. Excluded are pregnant/breastfeeding individuals, those on recent immunosuppressants or with serious health conditions.Check my eligibility
What is being tested?
The trial is testing an adjuvanted EBV gp350-Ferritin Vaccine against a placebo in preventing infectious mononucleosis. Participants will receive two injections a month apart and have follow-ups up to two years to monitor effectiveness and any potential onset of EBV infection.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, general symptoms like fever or fatigue, allergic responses, or other immune-related issues that could arise from vaccination. Specific side effects of this new vaccine will be closely monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean EBV neutralizing antibody from Day 0 to 30 days after the third dose of study vaccine in EBV gp350 Ferritin vaccine recipients as compared with placebo.
Secondary outcome measures
Reduction EBV related infectious mononucleosis as defined by signs and symptoms consistent with infectious mononucleosis with laboratory evidence for new EBV infection for up to 2 years post-vaccination as compared with placebo
Reduction in EBV infection as measured by new anti-EBV VCA IgG or IgM or new EBV viremia for up to 2 years post-vaccination as compared with placebo
Reduction of viremia measured by qPCR in EBV gp350 vaccine recipients as compared with placebo in participants who become infected with EBV
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionalExperimental Treatment2 Interventions
The gp350-Ferritin vaccine will be delivered intramuscularly into the deltoid muscle at Days 0, 30, and between 60 and 90. Each vaccine dose will consist of 50 micrograms of EBV gp350-Ferritin combined with 49 micrograms of Matrix-M1 adjuvant.
Group II: ControlPlacebo Group1 Intervention
The placebo will be delivered intramuscularly into the deltoid muscle at Days 0, 30, and between 60 and 90. Each dose will consist of 0.4mL normal saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matrix-M1 Adjuvant
2017
Completed Phase 2
~300
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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
3,270 Previous Clinical Trials
5,484,237 Total Patients Enrolled
Jessica R Durkee-Shock, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any live vaccines in the last 30 days.I haven't taken strong immune system or cancer drugs in the last 6 months.I have type 1 or type 2 diabetes, but not gestational diabetes.I haven't taken any experimental drugs in the last 30 days and won't while in this study.I have a seizure disorder not listed as an exception.I do not have a spleen or my spleen does not work properly.I am HIV positive.I have an active hepatitis B or C infection.I am between 18 and 25 years old.I have a bleeding disorder diagnosed by a doctor.I have not received blood products or immunoglobulins in the last 4 months.I have a form of angioedema, whether it's inherited, acquired, or of unknown cause.I have had Guillain-Barre Syndrome in the past.I have taken steroids equivalent to 10 mg of prednisone daily for more than 10 days in the last month.My body shape may make it hard to get a vaccine in my arm safely.I have a confirmed Epstein-Barr virus infection.I agree not to get any live vaccines 30 days before and after each study vaccine dose.My asthma has been severe, needing emergency care or steroids in the last 2 years.I have a cancer that might not stay cured or could come back during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Interventional
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my profile compatible with the requirements of this trial?
"Potential participants of this medical trial must have Epstein-Barr virus (EBV) infection, be aged 18-22, and out of 1000 applicants."
Answered by AI
Is there an upper age limit to the participants of this experiment?
"This trial is limited to adult participants aged 18-22. 200 studies are accessible for persons under the age of majority and 609 clinical trials can be found that enroll patients over 65 years old."
Answered by AI
Are there any opportunities to join this research initiative?
"As per the data on clinicaltrials.gov, this experiment is not presently looking for participants. It was initially posted in January of 2023 and last updated on 12th of that same month. Despite being closed to applicants currently, there exists 768 other trials open to new recruits at present."
Answered by AI
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