Epstein Barr Virus (EBV) InfectionPhase 1NCT07888088
Phase 1 Trial to Evaluate Safety and Immunogenicity of MVA-BN-EBV in Healthy Young Adults
A Phase 1 study testing MVA-BN-EBV in people with Epstein Barr Virus (EBV) Infection, run by Bavarian Nordic at 1 site in United States.
Trial summary
Phase 1, single-center, randomized, placebo-controlled, double-blind clinical trial. Participants (N = 15) will receive a 2-dose schedule (1 vaccination on day 1 and day 28) randomized, receiving either MVA-BN-EBV (n = 12) or placebo (n = 3). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Epstein Barr Virus (EBV) Infection
- What is being tested?
- MVA-BN-EBV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 31 Dec 2028
- Phase
- Phase 1
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and ≤30 years at screening
- Informed consent form (ICF) signed and dated by the participant after reading the form and being advised of the risks and benefits of the trial in a language understood by the participant and before performance of any trial-specific procedures
- General good health, without any clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the PI
- Body mass index (BMI) ≥18.5 and ≤35.0
- BMI formula for kilograms and meters (round to 1 decimal place): BMI = (body weight in kilograms) / (body height in meters)^2
- BMI formula for pounds and inches (round to 1 decimal place): BMI = (body weight in pounds) × 703 / (body height in inches)^2
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- Assertion by participant that one of the following regarding avoidance of pregnancy is true:
- Female participant or female partner(s) of male participant is at least 1 year postmenopausal (amenorrhea >12 consecutive months in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment, and documented FSH level of ≥40 mIU/mL) at screening
- Participant and/or participant's partner(s) is surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, confirmed hysteroscopic sterilization, such as Essure®, vasectomy)
- Female participant of childbearing potential or male participant who is sexually active with a female partner of childbearing potential agrees to use a highly effective method of birth control from at least 30 days prior to administration of vaccine until 60 days after last vaccination; medically acceptable methods of contraception that may be used by the participant and/or partner include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS) , bilateral tubal ligation, or true abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of vaccine until 60 days after last vaccination). Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Participant is in an exclusively same-sex relationship. These participants should not have plans to become pregnant by any other means for at least 60 days after IMP administration.
- No plans to become pregnant by intrauterine insemination or in vitro fertilization, to harvest eggs, or to donate or bank sperm through 60 days after last vaccination.
- Negative HIV antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG), and negative antibody test to hepatitis C virus (HCV)
- Willingness to comply with the requirements of the protocol, in the judgment of the investigator
Who cannot join
- Pregnancy or breast-feeding
- Any condition that, in the opinion of the investigator, creates an unacceptable risk to the participant
- Any condition that, in the opinion of the investigator, will interfere with the conduct of the trial or the validity of the data.
- Acute or chronic medical condition that, in the opinion of the PI, would render the trial procedures unsafe or would interfere with the evaluation of the responses, including but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions
- History of, or active autoimmune disease (vitiligo or thyroid disease requiring thyroid replacement are not exclusions), such as history of Guillain-Barré syndrome or Reye's syndrome
- Known immunodeficiency syndrome or known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, or moderate to severe kidney impairment
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- Known or suspected previous smallpox/mpox vaccination or vaccination with any licensed or investigational poxvirus-based vaccine
- History of monkeypox, cowpox, or vaccinia infection
- Close contact with anyone known to have mpox in the 3 weeks prior to signing ICF
- History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. Participants with history of skin cancer must not be vaccinated at the previous tumor site.
- Clinically significant mental disorder not adequately controlled by medical treatment
- Active or recent (within 6 months before screening) evidence of substance abuse (eg, chronic alcohol abuse and/or intravenous and/or nasal drug abuse) that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study
- History of known or suspected allergic disease or reaction likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, quail proteins.
- History of anaphylaxis or severe allergic reaction to any vaccine
- Receipt of or plans to receive any licensed live vaccine from 30 days prior to first trial vaccination until 30 days after last trial vaccination
- Receipt of or plans to receive any licensed non live vaccine from 14 days prior to first trial vaccination until 14 days after last trial vaccination
- Use of any investigational or nonregistered agent within 30 days prior to trial vaccination or plans to receive an investigational agent during the trial until 6 months after last trial vaccination
- Recent blood donation (including platelets, plasma, and red blood cells) within 4 weeks prior to screening and or planned blood donations through the EAP
- Use of systemic administration corticosteroids or any other immune modifying drugs defined as use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more from 3 months prior to the first trial vaccination to the EAP visit. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed
- History of organ transplantation, whether or not chronic immunosuppressive therapy is being administered
- Administration or planned administration of immunoglobulins (with an exception for monoclonal antibodies for treatment of migraines) and/or any blood products from 3 months prior to the first trial vaccination until the EAP visit (packed red blood cells given for an emergency indication in an otherwise healthy person and not required as ongoing treatment is not exclusionary [eg, packed red blood cells given in an emergency during elective surgery])
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, significant arrhythmia with or without corrective/ablative surgery, abnormal troponin I level > upper limit of normal (ULN), or any other heart condition under the care of a doctor
- Employment with the PI or CTS, with direct involvement in the proposed study or other studies under the direction of that PI or CTS, or relationship to the PI or CTS employee
- Relationship with Bavarian Nordic as an employee or employee family member, contractor, agent, or business partner, or having a financial interest in the outcome of the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Bavarian Nordic Investigative Site
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Safety and Immunogenicity of a Recombinant MVA-BN-EBV Vaccine in Healthy Young Adults From 18 to 30 Years of Age
Phase 1, single-center, randomized, placebo-controlled, double-blind clinical trial.
Participants (N = 15) will receive a 2-dose schedule (1 vaccination on day 1 and day 28) randomized, receiving either MVA-BN-EBV (n = 12) or placebo (n = 3).
Read the detailed description
Phase 1, single-center, randomized, placebo-controlled, double-blind clinical trial.
Participants (N = 15) will receive a 2-dose schedule (1 vaccination on day 1 and day 28) randomized, receiving either MVA-BN-EBV (n = 12) or placebo (n = 3).
Recruitment into the trial will be performed in a staggered approach. In each cohort, participants will be randomized to receive either MVA-BN-EBV or placebo. The trial will start with a sentinel cohort of 2 participants, 1 receiving the MVA-BN-EBV vaccine and the other receiving the placebo.
- Conditions
- Epstein Barr Virus (EBV) Infection
- Being tested
- MVA-BN-EBV, Placebo
- Keywords
- phase 1 study, healthy volunteer
- Medical subject headings
- Epstein-Barr Virus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-BN-EBVBiological
MVA-BN-EBV
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MVA-BN-EBV | Active comparator | Liquid frozen suspension of MVA-BN-EBV vaccine (distributed in single dose vials) will contain at least 3 × 108 Inf.U per 0.5 mL. MVA-BN-EBV vaccine will be given by intramuscular (IM) administration into the deltoid of the upper arm (preferably the non-dominant arm). Each participant will receive 2 vaccinations, 28 days apart. Receives: Biological: MVA-BN-EBV |
| Placebo | Placebo comparator | One dose of 0.5 mL placebo contains 0.605 mg trometamol (tris-hydroxymethyl-amino methane) and 4.09 mg sodium chloride (TBS). It is administered as an IM injection into the deltoid of the upper arm (preferably the non-dominant arm). Each participant will receive 2 vaccinations, 28 days apart. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious Adverse Events (SAEs)
Any postvaccination SAE, regardless of relationship to trial vaccine, throughout the trial
Measured: From first vaccination through Week 8
Number of participants with a grade 3 or higher AEs assessed as related to trial vaccine
Any grade 3 or higher AEs assessed as related to trial vaccine through the EAP
Measured: The day of or within 8 days after either vaccination
Number of participants with any solicited local and/or systemic AEs for an 8 day period
Any solicited local and/or systemic AEs for an 8-day period (day of vaccination plus 7 days)
Measured: The day of or within 8 days after either vaccination
Number of participants with any postvaccination MAAEs
Any postvaccination MAAEs, regardless of relationship to trial vaccine, throughout the trial
Measured: From first vaccination through the end of the trial at Week 32 (v5)
Number of participants with any postvaccination AESI
Any postvaccination AESI, regardless of relationship to trial vaccine, throughout the trial
Measured: From first vaccination through the end of the trial at Week 32 (v5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein Barr Virus (EBV) InfectionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888088
- Sponsor's protocol ID
- EBV-MVA-002
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No