MVA-BN-WEV Vaccine for Encephalitis

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and schedule for a new vaccine, MVA-BN-WEV, designed to protect against certain types of viral encephalitis (brain inflammation). Researchers will assess the vaccine's safety and effectiveness in generating an immune response. The trial includes two groups receiving different vaccine doses and one group receiving a placebo (an inactive substance). Ideal participants are healthy adults who have not received any previous encephalitis vaccines or infections and are not managing chronic health issues. As a Phase 2 trial, this study focuses on evaluating the vaccine's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to important medical research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the MVA-BN-WEV vaccine is generally safe for people. Studies have found that it boosts the immune system to help the body fight viruses and is safe to use. Participants in earlier studies did not experience major problems, regardless of whether they received a low or high dose. So far, it appears to be a promising way to prevent diseases caused by certain viruses without causing significant side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most existing treatments for encephalitis, which often focus on managing symptoms or using antiviral medications, the MVA-BN-WEV vaccine aims to provide direct immunity against the viruses that cause the condition. Researchers are excited about this vaccine because it uses a modified vaccinia Ankara platform, which has shown promise in offering strong and long-lasting immune responses with a good safety profile. Additionally, this vaccine is being tested in both low and high doses to find the optimal balance of effectiveness and safety, a flexibility that could improve patient outcomes.

What evidence suggests that the MVA-BN-WEV vaccine could be an effective treatment for encephalitis?

Research has shown that the MVA-BN-WEV vaccine holds promise for preventing brain infections caused by certain viruses. In earlier studies, the vaccine demonstrated 90 to 100% effectiveness in mice against two types of viruses that cause brain infections. Human trials have shown that MVA-BN-WEV is safe and enhances the body’s immune response, indicating its potential to protect people. This trial will evaluate different dosages of the MVA-BN-WEV vaccine, with participants receiving either a low dose, a high dose, or a placebo. The vaccine targets three types of viruses that cause brain infections, aiming to protect people from these serious illnesses. These findings suggest that MVA-BN-WEV could help reduce the risk of infection in humans. ^{2 3 6 7 8}

Who Is on the Research Team?

Carlos A. Fierro, MD

Principal Investigator

Johnson County Clin-Trials

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. bavarian-nordic.com bavarian-nordic.com/what-we-do/pipeline/equine-encephalitis.aspx

MVA-BN WEV Preclinical studies of MVA-BN WEV have demonstrated protective efficacy and results from a Phase 1 first-in-human trial showed that the vaccine was well ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X24002962

Safety and immunogenicity of a novel trivalent recombinant ... The study demonstrated that MVA-BN-WEV is well tolerated, induces immune responses, and is suitable for further development. Clinical Trial ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06899802

Study Details | NCT06899802 | A Phase 2 Trial in Healthy ... 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899228/

MVA-based vaccines are protective against lethal eastern ... Overall, the results indicate both vaccines are effective in eliciting an immune response that is consistent with protection from aerosolized ...

5. withpower.com withpower.com/trial/phase-2-encephalitis-2-2025-9449c

MVA-BN-WEV Vaccine for Encephalitis · Info for Participants 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38494412/

Safety and immunogenicity of a novel trivalent recombinant ... Conclusion: The study demonstrated that MVA-BN-WEV is well tolerated, induces immune responses, and is suitable for further development.

7. nature.com nature.com/articles/s41541-024-00842-y

MVA-based vaccines are protective against lethal eastern ... MVA-BN has been shown to be safe in humans, and generates robust and durable immune responses. The ability to simultaneously host several ...

8. bavarian-nordic.com bavarian-nordic.com/investor/news/news.aspx?news=6058

Bavarian Nordic Announces Topline Results ... Data from the study showed that the vaccine was well tolerated and immunogenic across all dose groups. Neutralizing antibody responses were ...