Epstein-Barr Virus InfectionPhase 1/2NCT05683834
Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-seronegative Persons
A Phase 1/2 study testing Matrix-M1 Adjuvant and EBV gp350-Ferritin Vaccine in people with Epstein-Barr Virus Infection and Infectious Mononucleosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Epstein-Barr Virus Infection, Infectious Mononucleosis, Herpesvirus
- What is being tested?
- Matrix-M1 Adjuvant and EBV gp350-Ferritin Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2023to 20 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase 1/2 Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-Seronegative Persons
Background:
Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Currently, there are no approved therapies or vaccines for EBV infection.
Read more
Objective:
To test a vaccine against EBV.
Eligibility:
Healthy people aged 18 to 25 years.
Design:
Participants will be screened in 2 parts. They will have a blood test. If that test shows they have never had an EBV infection, they will have a second clinic visit. They will have a physical exam, with blood and urine tests. A cotton swab will be rubbed on their gums to collect saliva.
Participants will receive 2 injections into a shoulder muscle. Some will receive the EBV vaccine. Others will receive a placebo; this contains harmless salt water with no vaccine. Participants will not know which one they are getting. The 2 injections will be 30 days apart.
Participants will be asked to record any side effects or symptoms they have between visits. They can do this on paper or online.
Participants will return for a follow-up visit 60 days after the first injection. They will have follow-up visits by phone or telehealth after 5 and 8 months. They will return for a physical exam after 13 months. They may come back for an optional physical exam after 2 years.
Participants will come to the clinic if they become ill with an EBV infection during the study.
Read the detailed description
Study Description:
This is a multisite randomized, double-blinded phase 1/2 study to evaluate the immunogenicity and safety of a 3-dose regimen of an adjuvanted EBV glycoprotein (gp) 350-Ferritin nanoparticle vaccine in EBV-seronegative persons. We hypothesize that the vaccine will be safe and induce a potent EBV gp350-specific immune response. Sixty EBV-seronegative participants will be randomized; 30 will receive the EBV gp350-Ferritin vaccine and 30 will receive the placebo at Days 0, 30, and between 60 and 90. Participants will be followed for 1 year after the third dose with an option to follow for a second year.
Primary Objective:
To evaluate the safety and immunogenicity of an adjuvanted EBV gp350-Ferritin vaccine administered to healthy EBV-seronegative adults.
Secondary Objectives:
- To evaluate the safety of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV-seronegative adults up to 30 days after the third dose of study vaccine.
- To preliminarily evaluate the efficacy of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV-seronegative adults.
Exploratory Objectives:
- To compare safety and immunogenicity of an accelerated 3-dose vaccination schedule (Days 0, 30, and 60 to 90) with the traditional vaccination schedule evaluated in NCT04645147.
- To further evaluate the immunogenicity of the EBV gp350-Ferritin vaccine.
Primary Endpoint:
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 Endpoints:
- Safety through 30 days after the third dose of the study vaccine:
- Solicited local and systemic reactions within 7 days after study vaccine administration.
- Unsolicited adverse events (AEs) through 30 days after the third dose of the study vaccine.
- Serious adverse events (SAEs) through 30 days after the third dose of the study vaccine.
- Reduction of viremia measured by quantitative polymerase chain reaction (qPCR) in EBV gp350-Ferritin vaccine recipients as compared with placebo in participants who become infected with EBV.
- Reduction of EBV infection as measured by new anti-EBV viral capsid antigen (VCA)-specific immunoglobulin (Ig) G or IgM or new EBV viremia for up to 2 years post-vaccination as compared with placebo.
- Reduction of 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.
- Time to EBV infection as measured by new anti EBV VCA IgG or IgM or new EBV viremia.
- Time to infectious mononucleosis as defined by signs and symptoms consistent with infectious mononucleosis with laboratory evidence for new EBV infection.
Exploratory Endpoints:
- Change in mean EBV neutralizing antibody from Day 0 to 30 days after the third dose of vaccine in EBV-seronegative vaccine recipients in the standard dosing regimen (Days 0, 30, and 180) vs accelerated (Days 0, 30, and 60 to 90).
- Safety through 30 days after the third dose of study vaccine in the standard dosing regimen (Days 0, 30, and 180) vs accelerated (Days 0, 30, and 60 to 90).
- Solicited local and systemic reactions within 7 days after vaccination.
- Unsolicited AEs through 30 days after the third dose of study vaccine.
- SAEs through 30 days after the third dose of study vaccine.
- Increase in EBV gp350 IgG antibody in blood and/or EBV gp350 IgA antibody in saliva in vaccine recipients as compared with placebo.
- Increase in CD4+ T-cell response in study vaccine recipients from baseline (pre-vaccine) to 30 days after the third dose of vaccine as compared with placebo in participants who become infected with EBV.
- Being tested
- Matrix-M1 Adjuvant, EBV gp350-Ferritin Vaccine, Placebo Comparator
- Keywords
- Infectious Mononucleosis, Neutralizing Antibody, Immune Response, Herpesvirus
- Medical subject headings
- Epstein-Barr Virus Infections, Infectious Mononucleosis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix-M1 AdjuvantDrug
Matrix-M1 is composed of 2 types of 40 nm-sized particles each with a different saponin fraction (fraction A and fraction B) combined with cholesterol and phospholipid.
EBV gp350-Ferritin VaccineDrug
The EBV gp350-Ferritin vaccine is composed of Helicobacter pylori non-heme ferritin fused to EBV gp350 which self-assembles to form a nanoparticle. The vaccine is supplied in single-use vials at a concentration of 250 micrograms/mL in 1.7 mM KH2PO4, 5 mM Na2HPO4, 150 mM NaCl, 5% sucrose, pH 7.4 (diluent).
Placebo ComparatorOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Other: Placebo Comparator |
| Interventional | Experimental | 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. Receives: Drug: Matrix-M1 Adjuvant; Drug: EBV gp350-Ferritin Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
To evaluate the safety and immunogenicity of the adjuvanted EBV gp350-Ferritin vaccine administered to healthy EBV-seronegative adults.
Measured: Day 90-120
Secondary outcomes (4)
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
To preliminarily evaluate the efficacy of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV seronegative adults.
Measured: Year 2
Reduction of viremia measured by qPCR in EBV gp350 vaccine recipients as compared with placebo in participants who become infected with EBV
To preliminarily evaluate the efficacy of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV seronegative adults.
Measured: End of Study
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
To preliminarily evaluate the efficacy of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV seronegative adults.
Measured: Year 2
Safety through day 90-120 Solicited local and systemic reactions within 7 days after study vaccine administration Unsolicited AEs through 30 days after the third dose of the study vaccine SAEs through 30 days after the th...
To evaluate the safety of the adjuvanted EBV gp350 Ferritin vaccine administered to EBV seronegative adults up to 30 days after the third dose of study vaccine.
Measured: Day 90-120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start22 Sep 2023
- Primary completion1 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epstein-Barr Virus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jessica R Durkee-Shock, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683834
- Sponsor's protocol ID
- 10001048
- Other IDs
- 001048-I
- Status last verified
- 20 Apr 2026
- First submitted
- 12 Jan 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual patient data may be shared with the FDA, IRB and other regulatory bodies to ensure the safe and proper conduct of the study.
Publications
Kanekiyo M, Bu W, Joyce MG, Meng G, Whittle JR, Baxa U, Yamamoto T, Narpala S, Todd JP, Rao SS, McDermott AB, Koup RA, Rossmann MG, Mascola JR, Graham BS, Cohen JI, Nabel GJ. Rational Design of an Epstein-Barr Virus Vaccine Targeting the Receptor-Binding Site. Cell. 2015 Aug 27;162(5):1090-100. doi: 10.1016/j.cell.2015.07.043. Epub 2015 Aug 13.
PubMed 26279189Cohen JI. Epstein-barr virus vaccines. Clin Transl Immunology. 2015 Jan 23;4(1):e32. doi: 10.1038/cti.2014.27. eCollection 2015 Jan.
PubMed 25671130Cohen JI, Fauci AS, Varmus H, Nabel GJ. Epstein-Barr virus: an important vaccine target for cancer prevention. Sci Transl Med. 2011 Nov 2;3(107):107fs7. doi: 10.1126/scitranslmed.3002878.
PubMed 22049067
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized, Double-Blinded, Placebo-Controlled Trial Evaluating the Immunogenicity and Safety of an Adjuvanted Epstein-Barr Virus (EBV) Glycoprotein 350 Vaccine in EBV-Seronegative Persons
- ClinicalTrials.gov ID
- NCT05683834
- Acronym / sponsor ID
- 10001048
- Keywords
- Infectious Mononucleosis, Neutralizing Antibody, Immune Response, Herpesvirus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Mono can cause fatigue that lasts more than 6 months, and some people can have severe complications. EBV infection may also contribute to some cancers and autoimmune diseases. Currently, there are no approved therapies or vaccines for EBV infection.
Objective:
To test a vaccine against EBV.
Eligibility:
Healthy people aged 18 to 25 years.
Design:
Participants will be screened in 2 parts. They will have a blood test. If that test shows they have never had an EBV infection, they will have a second clinic visit. They will have a physical exam, with blood and urine tests. A cotton swab will be rubbed on their gums to collect saliva.
Participants will receive 2 injections into a shoulder muscle. Some will receive the EBV vaccine. Others will receive a placebo; this contains harmless salt water with no vaccine. Participants will not know which one they are getting. The 2 injections will be 30 days apart.
Participants will be asked to record any side effects or symptoms they have between visits. They can do this on paper or online.
Participants will return for a follow-up visit 60 days after the first injection. They will have follow-up visits by phone or telehealth after 5 and 8 months. They will return for a physical exam after 13 months. They may come back for an optional physical exam after 2 years.
Participants will come to the clinic if they become ill with an EBV infection during the study.
Detailed description
Study Description:
This is a multisite randomized, double-blinded phase 1/2 study to evaluate the immunogenicity and safety of a 3-dose regimen of an adjuvanted EBV glycoprotein (gp) 350-Ferritin nanoparticle vaccine in EBV-seronegative persons. We hypothesize that the vaccine will be safe and induce a potent EBV gp350-specific immune response. Sixty EBV-seronegative participants will be randomized; 30 will receive the EBV gp350-Ferritin vaccine and 30 will receive the placebo at Days 0, 30, and between 60 and 90. Participants will be followed for 1 year after the third dose with an option to follow for a second year.
Primary Objective:
To evaluate the safety and immunogenicity of an adjuvanted EBV gp350-Ferritin vaccine administered to healthy EBV-seronegative adults.
Secondary Objectives:
- To evaluate the safety of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV-seronegative adults up to 30 days after the third dose of study vaccine.
- To preliminarily evaluate the efficacy of the adjuvanted EBV gp350-Ferritin vaccine administered to EBV-seronegative adults.
Exploratory Objectives:
- To compare safety and immunogenicity of an accelerated 3-dose vaccination schedule (Days 0, 30, and 60 to 90) with the traditional vaccination schedule evaluated in NCT04645147.
- To further evaluate the immunogenicity of the EBV gp350-Ferritin vaccine.
Primary Endpoint:
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 Endpoints:
- Safety through 30 days after the third dose of the study vaccine:
- Solicited local and systemic reactions within 7 days after study vaccine administration.
- Unsolicited adverse events (AEs) through 30 days after the third dose of the study vaccine.
- Serious adverse events (SAEs) through 30 days after the third dose of the study vaccine.
- Reduction of viremia measured by quantitative polymerase chain reaction (qPCR) in EBV gp350-Ferritin vaccine recipients as compared with placebo in participants who become infected with EBV.
- Reduction of EBV infection as measured by new anti-EBV viral capsid antigen (VCA)-specific immunoglobulin (Ig) G or IgM or new EBV viremia for up to 2 years post-vaccination as compared with placebo.
- Reduction of 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.
- Time to EBV infection as measured by new anti EBV VCA IgG or IgM or new EBV viremia.
- Time to infectious mononucleosis as defined by signs and symptoms consistent with infectious mononucleosis with laboratory evidence for new EBV infection.
Exploratory Endpoints:
- Change in mean EBV neutralizing antibody from Day 0 to 30 days after the third dose of vaccine in EBV-seronegative vaccine recipients in the standard dosing regimen (Days 0, 30, and 180) vs accelerated (Days 0, 30, and 60 to 90).
- Safety through 30 days after the third dose of study vaccine in the standard dosing regimen (Days 0, 30, and 180) vs accelerated (Days 0, 30, and 60 to 90).
- Solicited local and systemic reactions within 7 days after vaccination.
- Unsolicited AEs through 30 days after the third dose of study vaccine.
- SAEs through 30 days after the third dose of study vaccine.
- Increase in EBV gp350 IgG antibody in blood and/or EBV gp350 IgA antibody in saliva in vaccine recipients as compared with placebo.
- Increase in CD4+ T-cell response in study vaccine recipients from baseline (pre-vaccine) to 30 days after the third dose of vaccine as compared with placebo in participants who become infected with EBV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Placebo ComparatorThe 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. |
| Interventional | Experimental | Drug: Matrix-M1 Adjuvant, Drug: EBV gp350-Ferritin VaccineThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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).
Key exclusion criteria (32 listed)
- 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:
- Has any of the following:
- Prior enrollment in an EBV vaccine clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matrix-M1 AdjuvantMatrix-M1 is composed of 2 types of 40 nm-sized particles each with a different saponin fraction (fraction A and fraction B) combined with cholesterol and phospholipid. | Drug | Interventional |
| EBV gp350-Ferritin VaccineThe EBV gp350-Ferritin vaccine is composed of Helicobacter pylori non-heme ferritin fused to EBV gp350 which self-assembles to form a nanoparticle. The vaccine is supplied in single-use vials at a concentration of 250 micrograms/mL in 1.7 mM KH2PO4, 5 mM Na2HPO4, 150 mM NaCl, 5% sucrose, pH 7.4 (diluent). | Drug | Interventional |
| Placebo ComparatorNormal Saline | Other | Control |
Primary outcome
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.
Time frame: Day 90-120
To evaluate the safety and immunogenicity of the adjuvanted EBV gp350-Ferritin vaccine administered to healthy EBV-seronegative adults.
4 secondary outcomes
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
Time frame: Year 2
Reduction of viremia measured by qPCR in EBV gp350 vaccine recipients as compared with placebo in participants who become infected with EBV
Time frame: End of Study
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
Time frame: Year 2
Safety through day 90-120 Solicited local and systemic reactions within 7 days after study vaccine administration Unsolicited AEs through 30 days after the third dose of the study vaccine SAEs through 30 days after the th...
Time frame: Day 90-120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 26279189Kanekiyo M, Bu W, Joyce MG, Meng G, Whittle JR, Baxa U, Yamamoto T, Narpala S, Todd JP, Rao SS, McDermott AB, Koup RA, Rossmann MG, Mascola JR, Graham BS, Cohen JI, Nabel GJ. Rational Design of an Epstein-Barr Virus Vaccine Targeting the Receptor-Binding Site. Cell. 2015 Aug 27;162(5):1090-100. doi: 10.1016/j.cell.2015.07.043. Epub 2015 Aug 13.
- Background: PubMed 25671130Cohen JI. Epstein-barr virus vaccines. Clin Transl Immunology. 2015 Jan 23;4(1):e32. doi: 10.1038/cti.2014.27. eCollection 2015 Jan.
- Background: PubMed 22049067Cohen JI, Fauci AS, Varmus H, Nabel GJ. Epstein-Barr virus: an important vaccine target for cancer prevention. Sci Transl Med. 2011 Nov 2;3(107):107fs7. doi: 10.1126/scitranslmed.3002878.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual patient data may be shared with the FDA, IRB and other regulatory bodies to ensure the safe and proper conduct of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica R Durkee-Shock, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Matrix-M1 Adjuvant and EBV gp350-Ferritin Vaccine in people with Epstein-Barr Virus Infection and Infectious Mononucleosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 90-120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683834, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.