Could a vaccine finally stop the 'Kissing Disease'?
NCT ID NCT05683834
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new vaccine designed to prevent Epstein-Barr virus (EBV) infection, which causes most cases of infectious mononucleosis (mono). Twenty-five healthy adults aged 18 to 25 who had never been infected with EBV received either the vaccine or a placebo. The goal was to see if the vaccine is safe and triggers an immune response that could protect against EBV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EBV gp350-Ferritin vaccine with Matrix-M1 adjuvant
- What this could lead to
- If successful, this could lead to a vaccine that prevents Epstein-Barr virus infection and the fatigue and complications of mono.
- What could go wrong
- This is an early-phase trial with only 25 participants, so results may not apply to everyone. The vaccine may not provide strong or lasting protection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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25 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Apr 2026
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: * Aged 18 to 25 years. * Able to provide informed consent. * Willing to allow samples and data to be stored for future secondary research. * Stated willingness to comply with all study procedures and availability for the duration of the active phase of the study (approximately 18 months). * In good general health as evidenced by medical history, physical examination, and laboratory screening results. * Willing to forgo receipt of a licensed, live vaccine in the 30 days before and 30 days after each dose of the study vaccine. Any FDA-approved or authorized inactivated and/or protein subunit, RNA, or DNA vaccine can be used \>=14 days before or \>=14 days after administration of the study vaccine. * Hemoglobin within institutional normal limits, or if not, then assessed and deemed not clinically significant by PI or designee. * White blood cell count and differential within institutional normal reference range, or if not, then deemed not clinically significant by PI or designee. * Total lymphocyte count (lymphocyte absolute) \>800 cells/microliters. * Platelet count of 125,000 to 500,000/microliters. * Alanine aminotransferase \<1.25 x upper limit of normal. * Participants who can get pregnant must agree to abstain from sexual activities that can result in pregnancy or use one of the following effective methods of contraception, starting 30 days before the first dose of study vaccine through 60 days after the third dose: * Intrauterine device (IUD) or equivalent. * Hormonal contraceptive (eg, consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full efficacy before the first dose of study agent). If the participant uses a contraceptive pill, patch, or ring, then a barrier method (eg, internal/external condom, cervical cap, or diaphragm plus spermicide) must also be used at the time of potentially reproductive sexual activity. * A hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy. * Barrier method (eg, internal/external condom, cervical cap, or diaphragm) plus spermicide used correctly during sexual intercourse. * A vasectomy in their monogamous sexual partner completed at least 6 months before the first dose of study vaccine. * Continuous abstinence. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnant or breastfeeding, or planning to become pregnant while participating through 60 days after the third dose of study vaccine. * Has received any of the following: * More than 10 days of systemic glucocorticoids (\>=10 mg of prednisone or equivalent) within the 30 days prior to first dose of study agent. * More than 10 days of systemic immunosuppressive medications, cytotoxic medications, or immunomodulating therapy within 180 days prior to first dose of study agent. * Blood products, including immunoglobulins, within 120 days prior to first dose of study agent. * Any live attenuated vaccination within 30 days prior to first dose of study agent. * Investigational research agents within 30 days prior to first dose or planning to receive investigational products while on study. * Allergy treatment with antigen injections, unless on a maintenance schedule of shots no more frequently than once per month. * Has any of the following: * Febrile illness within 14 days of the first dose of study agent. * Body habitus such that identification of the deltoid muscle and/or administration of vaccine into the deltoid would be compromised or if body habitus would make study inclusion not in the best interest of the participant. * History of serious reactions to vaccines. * Hereditary, acquired, or idiopathic forms of angioedema. * Idiopathic urticaria within the past year. * Asthma that is not well-controlled or that required emergency care, urgent care, hospitalization, or intubation during the past 2 years, or that requires the use of oral or intravenous steroids. * Diabetes mellitus type 1 or type 2, excluding a history of gestational diabetes. * Clinically significant autoimmune disease or immunodeficiency. * Bleeding disorder diagnosed by doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions). * Significant bruising or bleeding difficulties with intramuscular injections or blood draws. * Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure or malignancy that is likely to recur during the study period. * Seizure disorder other than a history of 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the past 3 years. * Asplenia, functional asplenia, or any condition resulting in absence or removal of the spleen. * History of Guillain-Barre Syndrome. * Alcohol or drug abuse or addiction. * HIV infection. * Active hepatitis B or C infection. * Documented EBV infection. * Prior enrollment in an EBV vaccine clinical trial. * 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. Co-enrollment guidelines: Co-enrollment in other studies is restricted, other than enrollment on observational studies. Consideration for co-enrollment in trials evaluating the use of a licensed medication will require the approval of the PI or sponsor medical monitor (SMM). Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the PI or SMM.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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