Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in H… (NCT04645147) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults
United States83 participantsStarted 2022-03-29
Plain-language summary
Background:
Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine.
Objective:
To test the safety of and immune response to a new vaccine against EBV.
Eligibility:
Healthy adults ages 18-29
Design:
Participants will be screened with a medical history and physical exam. They will give a blood sample.
Screening tests will be repeated during the study.
Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined.
Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study.
Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose.
Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person.
Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.
Who can participate
Age range
18 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 29 years old
. Screening procedures and evaluations performed no more than 30 days prior to scheduled administration of the first vaccine dose.
. Ability of subject to understand and the willingness to sign a written informed consent document.
. Stated willingness to comply with all study procedures and availability for the duration of the active phase of the study (approximately 18 months)
. Willingness to allow storage of blood and saliva for future research.
. In good general health as evidenced by medical history, physical examination, and laboratory screening result.
. Subject is willing to forgo receipt of a licensed, live vaccine in the 30 days preceding each dose of vaccine or in the 30 days following each dose of vaccine. An FDA-approved inactivated, subunit or replication-defective vaccine (such as COVID-19, influenza,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited Local Adverse Events (AEs)
Timeframe: During the 7-day period after each dose of vaccine
2
Number of Participants With Solicited Local Adverse Events (AEs) (by Severity)
Timeframe: During the 7-day period after each dose of vaccine
3
Number of Participants With Solicited Systemic Adverse Events (AEs)
Timeframe: During the 7-day period after each dose of vaccine
4
Number of Participants With Solicited Systemic Adverse Events (AEs) (by Grade)
Timeframe: During the 7-day period after each dose of vaccine
5
Number of Related Serious Adverse Events (AEs)
Timeframe: Within one month after the third dose of vaccine (Day 180 through day 210)
6
Number of Related Unsolicited Adverse Events
Timeframe: Within 30 days after each dose of vaccine
7
Number of Unrelated Unsolicited Adverse Events
Trial details
NCT IDNCT04645147
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. For females of reproductive potential who are sexually active with a male partner: use of highly effective continuous contraception for at least 30 days prior to Day 0 and agreement to continue use until 60 days after the last dose of vaccine.
Exclusion criteria
. Women who are breastfeeding or planning to become pregnant while participating through 60 days after the last dose of vaccine
. Participant has received any of the following:
. Participant has any of the following:
. Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation or impairs the participant s ability to give informed consent.
Timeframe: Within 30 days after each dose of vaccine
8
Change in Neutralizing Antibody Responses to Epstein-Barr Virus (EBV) gp350-Ferritin Vaccine