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Virus Therapy
EBV Vaccine for EBV Infection
Phase 1
Waitlist Available
Led By Jeffrey I Cohen, 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
Contraceptive requirements: Because the effects of EBV gp350-Ferritin vaccine on the developing human fetus are unknown, sexually active female participants of childbearing potential must agree to use highly effective contraception as outlined below before study entry and until 60 days after the last dose of vaccine. Females of childbearing potential must have a negative pregnancy test before receiving each dose of the EBV gp350-Ferritin vaccine. During the course of the study, if a participant becomes pregnant or suspects they are pregnant, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are: Intrauterine device (IUD) or equivalent, Hormonal contraceptive (e.g. consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy prior to dosing). If the participant uses a contraceptive pill, path, or ring, then a barrier method (e.g. male/female condom, cap or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity, A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, e.g. has undergone a vasectomy at least 6 months prior to the first dose of vaccine or is of the same sex as the participant, A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy.
18 to 29 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up reactogenicity during the 7-day period after each dose; unsolicited adverse events up to 30 days after each dose; serious adverse events through 1 month after the third dose:; neutralizing antibody response one month after third dose
Awards & highlights
Study Summary
This trial is testing a new EBV vaccine to see if it is safe and if it causes an immune response. Healthy adults 18-29 can participate. There are 4 in-person visits and 6 telephone calls over 18 months.
Who is the study for?
Healthy adults aged 18-29 can join this trial to test a new EBV vaccine. They must be in good health, not planning to receive other live vaccines around the study period, and willing to use effective contraception. People with severe reactions to vaccines, certain chronic diseases like uncontrolled asthma or diabetes, or those on immunosuppressive drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and immune response of an Epstein-Barr Virus (EBV) gp350-Ferritin nanoparticle vaccine with Matrix-M1 adjuvant in healthy young adults. Participants will get three doses of the vaccine over several months and have follow-ups for about 18 months.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fever, fatigue, muscle pain, headache or nausea after vaccination. Participants will track any side effects using a diary card or electronic system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or agree to use effective birth control during and 60 days after the vaccine study.
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I am between 18 and 29 years old.
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I have had a hysterectomy or my fallopian tubes or ovaries removed.
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I have had a hysterectomy or my fallopian tubes or ovaries removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in antibody responses and change in cd4 t cell responses at 1 month after third dose of vaccine
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in antibody responses and change in cd4 t cell responses at 1 month after third dose of vaccine
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local and systemic reactogenicity; unsolicited adverse events; serious adverse events; change in neutralizing antibody responses to EBV
Secondary outcome measures
Change in antibody responses to EBV gp350; change in CD4+ T cell responses to EBV gp350
Trial Design
1Treatment groups
Experimental Treatment
Group I: EBV gp_350 Ferritin VaccinationExperimental Treatment2 Interventions
Adult participants with or without prior EBV infection will receive 3 doses of vaccine
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,386 Total Patients Enrolled
Jeffrey I Cohen, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
9 Previous Clinical Trials
2,507 Total Patients Enrolled
Jessica R Durkee-Shock, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
2 Previous Clinical Trials
1,600 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My partner uses effective birth control or has had surgery to prevent pregnancy.My asthma has been severe, needing emergency care or steroids in the last 2 years.My cancer is active or likely to come back during the study.I use hormonal birth control and a barrier method during sex.I haven't taken strong immune system medications or cancer drugs in the last month.I do not have a functioning spleen.I have a diagnosed bleeding disorder that needs special care.I have not needed treatment for seizures in the last 3 years, except for febrile or alcohol withdrawal-related ones over 3 years ago.I am using or agree to use effective birth control during and 60 days after the vaccine study.I have had Guillain-Barre Syndrome in the past.I am using effective birth control or have had a vasectomy.I have type 1 or type 2 diabetes, but not gestational diabetes.I have received specific treatments.I have a form of angioedema, whether it's inherited, acquired, or of unknown cause.I have a serious autoimmune disease or immunodeficiency.My high blood pressure is not well-controlled.My thyroid condition is not under control.I am between 18 and 29 years old.I agree to let my blood and saliva be stored for future research.I agree not to get any live vaccines around the time I receive the study vaccine.I am a man who will use effective birth control during and for 30 days after the trial.I agree to use effective birth control during and 60 days after the vaccine trial.I had a vasectomy more than 6 months ago.I have had a hysterectomy or my fallopian tubes or ovaries removed.I use a condom with spermicide, even though my partner is on birth control.I am using a hormonal contraceptive method that is fully effective.I have had a hysterectomy or my fallopian tubes or ovaries removed.I haven't received blood products or immunoglobulins in the last 120 days.I haven't received any live vaccines in the last 30 days.I have received vaccines like flu, pneumonia, or COVID-19 in the last 14 days.I have not had a fever or flu-like illness in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: EBV gp_350 Ferritin Vaccination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What risks might be associated with the EBV gp350-Ferritin Vaccine?
"Our team at Power considers the safety of EBV gp350-Ferritin Vaccine to be relatively low, as evidenced by its score of 1. This is reflective of it being a Phase 1 trial with minimal evidence supporting efficacy and safety."
Answered by AI
Are there any prerequisites for those wishing to join this medical study?
"This medical trial is recruiting 500 participants aged between 18 and 29 who currently have an Epstein-Barr virus infection. Furthermore, they must meet the following conditions: be of eligible age; recently completed screening procedures and evaluations; understand and sign a written informed consent document; comply with all study protocols for approximately 18 months; allow storage of blood/saliva samples for future research purposes; possess general good health as evidenced by medical history, physical exams & lab tests results; forego receiving any live vaccines in 30 days prior to or after each vaccine dose (inactivated subunit/replication defective ones are allowed >=14 days before or after);"
Answered by AI
Is the current cohort of this trial still accepting participants?
"Data published on the clinicaltrials.gov website indicates that this trial is actively seeking volunteers. It was launched on March 29th 2022 and underwent its most recent update November 16th of the same year."
Answered by AI
Does the trial include elderly participants aged 85 years or older?
"According to the requirements for participation, only individuals aged 18-29 can enrol in this clinical study."
Answered by AI
What is the maximum cohort size for participating in this experiment?
"Affirmative. According to the clinicaltrials.gov information, this research project is actively seeking participants with a start date of March 29th 2022 and an update datum on November 16th 2022. A total of 500 patients must be recruited from 1 site for inclusion in the study."
Answered by AI
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