EncephalitisPhase 2NCT06899802
A Phase 2 Trial in Healthy Adult Participants of the Recombinant MVA-BN-WEV Vaccine
A Phase 2 study testing MVA-BN-WEV in people with Encephalitis, run by Bavarian Nordic at 9 sites in United States.
Trial summary
This phase 2 clinical trial will investigate an optimal dose, dosing regimen, and evaluate reactogenicity, safety and immunogenicity in healthy adult participants of the recombinant, multivalent MVA-BN-WEV vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis
- What is being tested?
- MVA-BN-WEV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 411 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Mar 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants ≥18 and ≤50 years of age at screening.
- General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
- Prior to performance of any trial specific procedures, the participant has read, signed, and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the participant, and has signed the Health Insurance Portability and Accountability Act authorization form.
- Body mass index (BMI) ≥18.5 and ≤35.
- BMI formula for pounds and inches: BMI = (body weight in pounds) × 703 / (body height in inches)m2
- Female participants should fulfil one of the following criteria:
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- At least 1 year post-menopausal (amenorrhea > 12 months) at screening.
- Surgically sterile (bilateral oophorectomy, bilateral tubal ligation, hysterectomy)
- Will use contraceptives as outlined in inclusion criterion 6 from screening until 30 days after last vaccination.
- Female participants of childbearing potential and male participants who are sexually active with a female partner of childbearing potential must agree to the use of a highly effective method of birth control from at least 30 days prior to administration of the MVA-BN-WEV vaccine to until last vaccination. Note: 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 occlusion, vasectomy or abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the MVA BN WEV vaccine until 30 days after last vaccination).
- Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus.
Who cannot join
- Pregnant or breast-feeding women.
- Participant has an acute or chronic medical condition that, in the opinion of the investigator, 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; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, moderate to severe kidney impairment. A known immunodeficiency syndrome.
- Known or suspected previous alphavirus infections or previous vaccination (EEEV, VEEV, WEEV, Chikungunya).
- Known or suspected previous smallpox vaccination, vaccination with a poxvirus-based vaccine, or mpox infection.
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- 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 history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the period of 6 months before screening).
- History of allergic disease or reactions 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.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to first or after last trial vaccination.
- Having received any vaccinations or planned vaccinations with a non-live or ribonucleic acid (RNA-) based vaccine within 14 days prior to first or after each trial vaccination.
- Recent blood donation (including platelets, plasma, and red blood cells) within 4 weeks prior screening, or planned blood donations during active trial period (ie, until the end of the active trial visit).
- Chronic systemic administration (defined as more than 14 days) of > 10 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending at the end of the active trial period Visit. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
- Post organ transplant participants whether or not receiving chronic immunosuppressive therapy.
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending at the end of the active trial period Visit. Receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an 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, or any other heart condition under the care of a doctor.
- Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of the trial vaccine, or planned administration of such a drug during the trial period until 12 months after the last vaccination visit (stage 1) or 6 months after last vaccination (stage 2).
- Employment with the investigator or CTS, with direct involvement in the proposed study or other studies under the direction of that investigator or CTS, or relationship to the investigator or CTS employee.
- Association with Bavarian Nordic as staff, contractors, agents, or business partners or any financial interest in the outcome of the trial.
- Federal employees and active-duty military personnel.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Jefferson City Medical Group / Avacare
Jefferson City, Missouri, 65109
Clay-Platte Family Medicine, P.C./CCT Research
Kansas City, Missouri, 64151
Benchmark Research
Kenner, Louisiana, 70065
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Lifeline Primary Care, Inc. / CCT Research
Lilburn, Georgia, 30047
Papillion Research Center/CCT Research
Papillion, Nebraska, 68046
Benchmark Research
Sacramento, California, 95864
Benchmark Research
San Angelo, Texas, 76904
Versailles Family Medicine, PLLC/CCT Research
Versailles, Kentucky, 40383
About this study
Official title: A Two-stage, Randomized, Double-blind, Dose Ranging Phase 2 Trial in Healthy Adult Participants to Investigate Optimal Dose and Dosing Regimen, and to Evaluate Safety and Immunogenicity of the Recombinant MVA-BN-WEV Vaccine
This phase 2 clinical trial will investigate an optimal dose, dosing regimen, and evaluate reactogenicity, safety and immunogenicity in healthy adult participants of the recombinant, multivalent MVA-BN-WEV vaccine. MVA-BN-WEV is intended for active immunization for prevention of disease induced by VEEV and EEEV, in persons aged 18 years and older at high risk of exposure.
- Conditions
- Encephalitis
- Being tested
- MVA-BN-WEV, Placebo
- Keywords
- vaccine, equine encephalitis, healthy participants, phase 2
- Medical subject headings
- Encephalitis, Encephalomyelitis, Equine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-BN-WEVBiological
Also called MVA-mBN396
MVA-mBN396 (common name MVA-BN-WEV vaccine), is a highly attenuated, live recombinant virus based on the licensed viral vector MVA-BN, provided as a liquid frozen formulation. It is administered as an intramuscular injection.
PlaceboOther
Also called Tris Buffered Saline
Tris-Buffered Saline (TBS) (placebo) is a clear liquid, free from visible extraneous particles. TBS is acceptable for use as a diluent and for intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| MVA-BN-WEV Low Dose | Active comparator | Participants in MVA-BN-WEV Lose Dose group will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of at least MVA-BN-WEV 1.2 x 10E8 Inf.U in Stage 1. 1 additional dose at 1 year after the second administration of the vaccine if Low Dose is the optimal dose for Stage 2. Receives: Biological: MVA-BN-WEV |
| MVA-BN-WEV High Dose | Active comparator | Participants in MVA-BN-WEV High Dose group will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of at least MVA-BN-WEV 3 x 10E8 Inf.U in Stage 1. 1 additional dose at 1 year after the second administration of the vaccine if High Dose is the optimal dose for Stage 2. Receives: Biological: MVA-BN-WEV |
| Placebo | Placebo comparator | Participants in Placebo group will receive 2 administrations 4 weeks apart with Tris-Buffered Saline in Stage 1. 1 additional dose at 1 year after the second administration of Tris-Buffered Saline for Stage 2. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose of MVA-BN-WEV vaccine in adult participants in terms of immunogenicity based on eastern equine encephalitis virus (EEEV)- and Venezuelan equine encephalitis virus (VEEV)-specific humoral immune responses to the MVA-BN-WEV vaccination.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measured by ELISA against EEEV and VEEV at 2 weeks after the second trial vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measured by PRNT against EEEV and VEEV at 2 weeks after the second trial vaccination.
Measured: 2 weeks after second vaccination.
Booster response of MVA-BN-WEV versus placebo in terms of immunogenicity based on EEEV- and VEEV- specific humoral immune responses to the MVA-BN-WEV vaccine.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measure by ELISA against EEEV and VEEV at 2 weeks after the third vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measure by PRNT against EEEV and VEEV at 2 weeks after the third vaccination.
Measured: 2 weeks after third vaccination.
Secondary outcomes (3)
Safety and reactogenicity of the MVA-BN-WEV vaccine and placebo in terms of solicited and unsolicited AEs in participants throughout the trial.
Participants reporting:
Stage 1 and 2:
- Any SAE, regardless of relationship, throughout the trial (first vaccination through the end of the trial).
- Any AESI regardless of relationship from first vaccination through the end of the trial.
Stage 1:
- Any grade 3 or higher solicited or unsolicited AEs assessed as related to trial vaccine from first vaccination through end of active treatment period stage 1.
Stage 2:
- Any grade 3 or higher solicited or unsolicited AEs assessed as related to trial vaccine from third vaccination through end of active treatment period stage 2.
Measured: Duration of trial (approximately 19 mon) for SAE or AESI or during active trial period (defined as the period from 1st vaccination up to and including the end of active trial period for stage 1 (4 wks after 2nd vaccination)/stage 2 (4 wks after booster).
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine.
- Serum binding antibody titers against WEEV as determined by ELISA, 2 weeks after second vaccination.
- Seroconversion response in terms of serum binding antibody titers against WEEV, EEEV, and VEEV as determined by ELISA, 2 weeks after second vaccination.
- Serum neutralizing antibody titers against WEEV, and VV as determined by PRNT, 2 weeks after second vaccination.
- Seroconversion response in terms of neutralizing antibody titers against WEEV, EEEV, VEEV, and VV as determined by PRNT, 2 weeks after second vaccination.
Measured: 2 weeks after second vaccination.
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo.
- Serum binding antibody titers against WEEV as determined by ELISA, 2 weeks after third vaccination.
- Serum neutralizing antibody titers against WEEV, and VV as determined by PRNT, 2 weeks after third vaccination.
Measured: 2 weeks after third vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start10 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalitisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JPM CBRN Medical
- Responsible party
- Sponsor
- Investigators
- Carlos A. Fierro, MD, Principal investigator, Johnson County Clin-Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899802
- Sponsor's protocol ID
- WEV-MVA-002
- Status last verified
- Jul 2025
- First submitted
- 6 Mar 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-stage, Randomized, Double-blind, Dose Ranging Phase 2 Trial in Healthy Adult Participants to Investigate Optimal Dose and Dosing Regimen, and to Evaluate Safety and Immunogenicity of the Recombinant MVA-BN-WEV Vaccine
- ClinicalTrials.gov ID
- NCT06899802
- Acronym / sponsor ID
- WEV-MVA-002
- Conditions
- Encephalitis
- Keywords
- vaccine, equine encephalitis, healthy participants, phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- JPM CBRN Medical
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Mar 2025 (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.
This phase 2 clinical trial will investigate an optimal dose, dosing regimen, and evaluate reactogenicity, safety and immunogenicity in healthy adult participants of the recombinant, multivalent MVA-BN-WEV vaccine. MVA-BN-WEV is intended for active immunization for prevention of disease induced by VEEV and EEEV, in persons aged 18 years and older at high risk of exposure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MVA-BN-WEV Low Dose | Active comparator | Biological: MVA-BN-WEVParticipants in MVA-BN-WEV Lose Dose group will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of at least MVA-BN-WEV 1.2 x 10E8 Inf.U in Stage 1. 1 additional dose at 1 year after the second administration of the vaccine if Low Dose is the optimal dose for Stage 2. |
| MVA-BN-WEV High Dose | Active comparator | Biological: MVA-BN-WEVParticipants in MVA-BN-WEV High Dose group will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of at least MVA-BN-WEV 3 x 10E8 Inf.U in Stage 1. 1 additional dose at 1 year after the second administration of the vaccine if High Dose is the optimal dose for Stage 2. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in Placebo group will receive 2 administrations 4 weeks apart with Tris-Buffered Saline in Stage 1. 1 additional dose at 1 year after the second administration of Tris-Buffered Saline for Stage 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female participants ≥18 and ≤50 years of age at screening.
- General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
- Prior to performance of any trial specific procedures, the participant has read, signed, and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the participant, and has signed the Health Insurance Portability and Accountability Act authorization form.
- Body mass index (BMI) ≥18.5 and ≤35.
- Female participants should fulfil one of the following criteria:
Key exclusion criteria (22 listed)
- Pregnant or breast-feeding women.
- Participant has an acute or chronic medical condition that, in the opinion of the investigator, 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; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, moderate to severe kidney impairment. A known immunodeficiency syndrome.
- Known or suspected previous alphavirus infections or previous vaccination (EEEV, VEEV, WEEV, Chikungunya).
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 |
|---|---|---|
| MVA-BN-WEVAlso: MVA-mBN396MVA-mBN396 (common name MVA-BN-WEV vaccine), is a highly attenuated, live recombinant virus based on the licensed viral vector MVA-BN, provided as a liquid frozen formulation. It is administered as an intramuscular injection. | Biological | MVA-BN-WEV High Dose, MVA-BN-WEV Low Dose |
| PlaceboAlso: Tris Buffered SalineTris-Buffered Saline (TBS) (placebo) is a clear liquid, free from visible extraneous particles. TBS is acceptable for use as a diluent and for intramuscular injection. | Other | Placebo |
Primary outcome
Optimal dose of MVA-BN-WEV vaccine in adult participants in terms of immunogenicity based on eastern equine encephalitis virus (EEEV)- and Venezuelan equine encephalitis virus (VEEV)-specific humoral immune responses to the MVA-BN-WEV vaccination.
Time frame: 2 weeks after second vaccination.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measured by ELISA against EEEV and VEEV at 2 weeks after the second trial vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measured by PRNT against EEEV and VEEV at 2 weeks after the second trial vaccination.
Booster response of MVA-BN-WEV versus placebo in terms of immunogenicity based on EEEV- and VEEV- specific humoral immune responses to the MVA-BN-WEV vaccine.
Time frame: 2 weeks after third vaccination.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measure by ELISA against EEEV and VEEV at 2 weeks after the third vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measure by PRNT against EEEV and VEEV at 2 weeks after the third vaccination.
3 secondary outcomes
Safety and reactogenicity of the MVA-BN-WEV vaccine and placebo in terms of solicited and unsolicited AEs in participants throughout the trial.
Time frame: Duration of trial (approximately 19 mon) for SAE or AESI or during active trial period (defined as the period from 1st vaccination up to and including the end of active trial period for stage 1 (4 wks after 2nd vaccination)/stage 2 (4 wks after booster).
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine.
Time frame: 2 weeks after second vaccination.
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo.
Time frame: 2 weeks after third vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Carlos A. Fierro, MD principal investigator
Johnson County Clin-Trials
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-BN-WEV in people with Encephalitis, run by Bavarian Nordic at 9 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 11 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
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?
Optimal dose of MVA-BN-WEV vaccine in adult participants in terms of immunogenicity based on eastern equine encephalitis virus (EEEV)- and Venezuelan equine encephalitis virus (VEEV)-specific humoral immune responses to the MVA-BN-WEV vaccination. (time frame: 2 weeks after second vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.