MVA-BN-WEV Vaccine for Encephalitis

Recruiting at 8 trial locations

Overseen By Bernard H. Hoet, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Bavarian Nordic

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Pregnancy, Autoimmune, Immunodeficiency, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that affect the immune system, like prednisone over 10 mg per day, you may need to stop them before joining the trial.

What data supports the effectiveness of the MVA-BN-WEV treatment for encephalitis?

Research shows that the MVA-BN-WEV vaccine, which targets three types of encephalitis viruses, provided 90 to 100% protection in mice against two of these viruses and 60% to 90% protection against the third. This suggests it could be a promising treatment for preventing encephalitis caused by these viruses. ^{1 2 3 4 5}

Is the MVA-BN-WEV vaccine generally safe for humans?

The MVA-BN vaccine platform, used in the MVA-BN-WEV vaccine, has been tested in over 7800 people and is considered safe, with a safety profile similar to other modern vaccines. It has been approved for use in smallpox, monkeypox, and Ebola vaccines, showing no significant risk of inflammatory heart conditions, unlike older vaccines. ^{1 2 3 6 7}

How is the MVA-BN-WEV vaccine treatment different from other treatments for encephalitis?

The MVA-BN-WEV vaccine is unique because it is a trivalent vaccine that targets three different encephalitic viruses (western, eastern, and Venezuelan equine encephalitis viruses) in a single formulation, using a non-replicating viral vector platform that has shown safety in other vaccines. This approach is novel as there are currently no licensed vaccines for these viruses, and it offers potential protection against all three with a single vaccine. ^{1 2 3 8 9}

Research Team

Carlos A. Fierro, MD

Principal Investigator

Johnson County Clin-Trials

Eligibility Criteria

This trial is for healthy adults aged 18 and older who are at high risk of exposure to diseases caused by VEEV and EEEV. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

Participant has read, signed, and dated an informed consent form in a language understood by the participant

Body mass index (BMI) between 18.5 and 35

Negative human immunodeficiency virus antibody test, negative hepatitis B surface antigen, and negative antibody to hepatitis C virus

Exclusion Criteria

Use of investigational or non-registered drugs or vaccines

Employment with the investigator or CTS, or association with Bavarian Nordic

Federal employees and active-duty military personnel

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants receive 2 administrations of the MVA-BN-WEV vaccine or placebo 4 weeks apart

8 weeks

2 visits (in-person)

Follow-up Stage 1

Participants are monitored for safety and immunogenicity 2 weeks after the second vaccination

2 weeks

1 visit (in-person)

Treatment Stage 2

Participants receive an additional dose of the MVA-BN-WEV vaccine or placebo 1 year after the second administration if the dose is optimal

1 year

1 visit (in-person)

Follow-up Stage 2

Participants are monitored for safety and immunogenicity 2 weeks after the third vaccination

2 weeks

1 visit (in-person)

Treatment Details

Interventions

• MVA-BN-WEV

Trial Overview The trial is testing a new vaccine called MVA-BN-WEV against a placebo. It aims to find the best dose, how often it should be given, and assess its safety and ability to provoke an immune response in participants.

Participant Groups

Group I: MVA-BN-WEV Low Dose Active Control 1 Intervention

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.

Group II: MVA-BN-WEV High Dose Active Control 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Bavarian Nordic

Lead Sponsor

Trials

67

Recruited

50,900+

Paul Chaplin

Bavarian Nordic

Chief Executive Officer since 2014

PhD in Immunology from Bristol University

Jean-Christophe May

Bavarian Nordic

Chief Medical Officer since 2020

PharmD and MBA

JPM CBRN Medical

Collaborator

Trials

2

Recruited

450+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Protective efficacy of monovalent and trivalent recombinant MVA-based vaccines against three encephalitic alphaviruses. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Monovalent and Trivalent MVA-Based Vaccine Completely Protects Mice Against Lethal Venezuelan, Western, and Eastern Equine Encephalitis Virus Aerosol Challenge. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The Brighton Collaboration standardized template for collection of key information for risk/benefit assessment of a Modified Vaccinia Ankara (MVA) vaccine platform. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of modified vaccinia Ankara in hematopoietic stem cell transplant recipients: a randomized, controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial Investigating the Safety and Immunogenicity of Modified Vaccinia Ankara Smallpox Vaccine (MVA-BN®) in 56-80-Year-Old Subjects. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States. The VAERS Working Group. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse event reports following Japanese encephalitis vaccination in the United States, 1999-2009. [2010]

8. Australia pubmed.ncbi.nlm.nih.gov

Sublingual immunization with Japanese encephalitis virus vaccine effectively induces immunity through both cellular and humoral immune responses in mice. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial. [2023]