Equine EncephalitisPhase 1NCT04131595
Vaccination Trial of a Recombinant MVA-BN-WEV Vaccine in Healthy Adult Subjects
A Phase 1 study testing MVA-BN-WEV Dose 1, MVA-BN-WEV Dose 2 and MVA-BN-WEV Dose 3 in people with Equine Encephalitis, run by Bavarian Nordic at 1 site in United States.
Trial summary
To assess safety and tolerability as well as immune responses to the MVA-BN-WEV vaccine in the 3 treatment groups receiving different doses. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Equine Encephalitis
- What is being tested?
- MVA-BN-WEV Dose 1, MVA-BN-WEV Dose 2 and MVA-BN-WEV Dose 3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 22 Jul 2020
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Male and female subjects ≥18 and ≤50 years of age at screening (SCR).
- 2. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
- 3. Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act authorization form (HIPAA).
- 4. Body mass index (BMI) ≥18.5 and ≤35.
- 5. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from at least 30 days prior to administration of the vaccine to until 30 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal (defined as ≥12 months without a menstrual period at SCR) or surgically sterilize (bilateral oophorectomy, bilateral tubal ligation, hysterectomy). Acceptable contraception methods are restricted to abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the vaccine until 30 days after the last vaccination), double barrier contraceptives, vasectomy, intrauterine contraceptive devices or licensed hormonal products.
- 6. Women of Childbearing Potential (WOCBP) must have a negative serum pregnancy test at SCR.
- 7. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus.
- 8. Troponin I within normal limits at SCR.
Who cannot join
- 1. Pregnant or breast-feeding women.
- 2. Subject 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.
- 3. Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase (AST), alanine amino transferase (ALT), alkaline phosphokinase (AP), bilirubin, or creatinine values), pulse rate and/or blood pressure, or electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by the investigator.
- 4. History of or active autoimmune disease; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. History of Guillain-Barré syndrome or Reye's syndrome.
- 5. 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.
- 6. Known or suspected previous smallpox vaccination or vaccination with a poxvirus-based vaccine.
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- 7. Known or suspected previous alphavirus infections (Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV), Western Equine Encephalitis Virus (WEEV), Chikungunya).
- 8. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to SCR that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
- 9. Clinically significant mental disorder not adequately controlled by medical treatment.
- 10. Active or recent history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the time period of 6 months before SCR).
- 11. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamicin, ciprofloxacin.
- 12. Known allergy to eggs.
- 13. History of anaphylaxis or severe allergic reaction to any vaccine.
- 14. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to first or after last trial vaccination.
- 15. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to first or after last trial vaccination.
- 16. Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior screening, or planned blood donations during active trial phase (until EAP Visit).
- 17. Chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day or any other immunemodifying drugs during a period starting 3 months prior to administration of the vaccine and ending at the last visit of the active treatment phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
- 18. Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- 19. 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 last visit of the active treatment phase. Receipt of packed red blood cells given for an emergent indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells emergently given during an elective surgery).
- 20. 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.
- 21. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period until the Follow-Up (FU) Visit 6 months after the last vaccination visit.
- 22. Clinical trial site personnel involved in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Vaccination Trial to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant MVA-BN-WEV Vaccine in Healthy Adult Subjects
To assess safety and tolerability as well as immune responses to the MVA-BN-WEV vaccine in the 3 treatment groups receiving different doses.
- Conditions
- Equine Encephalitis
- Being tested
- MVA-BN-WEV Dose 1, MVA-BN-WEV Dose 2, MVA-BN-WEV Dose 3
- Medical subject headings
- Encephalomyelitis, Equine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-BN-WEV Dose 1Biological
1 x 10^7 Inf.U MVA-BN-WEV vaccine
MVA-BN-WEV Dose 2Biological
1 x 10^8 Inf.U MVA-BN-WEV vaccine
MVA-BN-WEV Dose 3Biological
2 x 10^8 Inf.U MVA-BN-WEV vaccine.
| Study group | Role | What they receive |
|---|---|---|
| MVA-BN-WEV Dose 1 | Experimental | Subjects in treatment Group 1 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 1 x 107 Inf.U in 0.5 mL. Receives: Biological: MVA-BN-WEV Dose 1 |
| MVA-BN-WEV Dose 2 | Experimental | Subjects in treatment Group 2 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 1 x 108 Inf.U in 0.5 mL Receives: Biological: MVA-BN-WEV Dose 2 |
| MVA-BN-WEV Dose 3 | Experimental | Subjects in treatment Group 3 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 2 x 108 Inf.U in 2 x 0.5 mL Receives: Biological: MVA-BN-WEV Dose 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Number of subjects reporting any serious adverse events (SAE)
Number of subjects reporting any serious adverse events (SAE)
Measured: within 7 months after vaccinations of subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start7 Oct 2019
- Primary completion22 Jul 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Equine 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JPM CBRN Medical
- Responsible party
- Sponsor
- Investigators
- Carlos Fierro, MD, Principal investigator, JCCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131595
- Sponsor's protocol ID
- WEV-MVA-001
- Status last verified
- Aug 2020
- First submitted
- 16 Oct 2019
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fierro C, Weidenthaler H, Vidojkovic S, Schmidt D, Gafoor Z, Stroukova D, Zwiers S, Muller J, Volkmann A. Safety and immunogenicity of a novel trivalent recombinant MVA-based equine encephalitis virus vaccine: A Phase 1 clinical trial. Vaccine. 2024 Apr 11;42(10):2695-2706. doi: 10.1016/j.vaccine.2024.03.011. Epub 2024 Mar 16.
PubMed 38494412
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Vaccination Trial to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant MVA-BN-WEV Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04131595
- Acronym / sponsor ID
- WEV-MVA-001
- Conditions
- Equine Encephalitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- JPM CBRN Medical
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 18 Oct 2019 (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.
To assess safety and tolerability as well as immune responses to the MVA-BN-WEV vaccine in the 3 treatment groups receiving different doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MVA-BN-WEV Dose 1 | Experimental | Biological: MVA-BN-WEV Dose 1Subjects in treatment Group 1 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 1 x 107 Inf.U in 0.5 mL. |
| MVA-BN-WEV Dose 2 | Experimental | Biological: MVA-BN-WEV Dose 2Subjects in treatment Group 2 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 1 x 108 Inf.U in 0.5 mL |
| MVA-BN-WEV Dose 3 | Experimental | Biological: MVA-BN-WEV Dose 3Subjects in treatment Group 3 will receive 2 administrations 4 weeks apart with MVA-BN-WEV vaccine of 2 x 108 Inf.U in 2 x 0.5 mL |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1. Male and female subjects ≥18 and ≤50 years of age at screening (SCR).
- 2. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
- 3. Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act authorization form (HIPAA).
- 4. Body mass index (BMI) ≥18.5 and ≤35.
- 5. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from at least 30 days prior to administration of the vaccine to until 30 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal (defined as ≥12 months without a menstrual period at SCR) or surgically sterilize (bilateral oophorectomy, bilateral tubal ligation, hysterectomy). Acceptable contraception methods are restricted to abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the vaccine until 30 days after the last vaccination), double barrier contraceptives, vasectomy, intrauterine contraceptive devices or licensed hormonal products.
Key exclusion criteria (22 listed)
- 1. Pregnant or breast-feeding women.
- 2. Subject 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.
- 3. Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase (AST), alanine amino transferase (ALT), alkaline phosphokinase (AP), bilirubin, or creatinine values), pulse rate and/or blood pressure, or electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by the investigator.
- 4. History of or active autoimmune disease; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. History of Guillain-Barré syndrome or Reye's syndrome.
- 5. 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.
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-WEV Dose 11 x 10^7 Inf.U MVA-BN-WEV vaccine | Biological | MVA-BN-WEV Dose 1 |
| MVA-BN-WEV Dose 21 x 10^8 Inf.U MVA-BN-WEV vaccine | Biological | MVA-BN-WEV Dose 2 |
| MVA-BN-WEV Dose 32 x 10^8 Inf.U MVA-BN-WEV vaccine. | Biological | MVA-BN-WEV Dose 3 |
Primary outcome
Safety and Tolerability: Number of subjects reporting any serious adverse events (SAE)
Time frame: within 7 months after vaccinations of subjects
Number of subjects reporting any serious adverse events (SAE)
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 20 Aug 2020.
- Derived from this study: PubMed 38494412Fierro C, Weidenthaler H, Vidojkovic S, Schmidt D, Gafoor Z, Stroukova D, Zwiers S, Muller J, Volkmann A. Safety and immunogenicity of a novel trivalent recombinant MVA-based equine encephalitis virus vaccine: A Phase 1 clinical trial. Vaccine. 2024 Apr 11;42(10):2695-2706. doi: 10.1016/j.vaccine.2024.03.011. Epub 2024 Mar 16.
- 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 Fierro, MD principal investigator
JCCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-BN-WEV Dose 1, MVA-BN-WEV Dose 2 and MVA-BN-WEV Dose 3 in people with Equine Encephalitis, run by Bavarian Nordic at 1 site 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 8 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: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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.
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?
Safety and Tolerability: Number of subjects reporting any serious adverse events (SAE) (time frame: within 7 months after vaccinations of subjects). 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 NCT04131595, which also lists 1 linked publication.
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 20 Aug 2020.