Vaccination Trial of a Recombinant MVA-BN-WEV Vaccine in Healthy Adult Subjects

NCT04131595 | Completed Phase 1 FDA Drug

• 1 other identifier: WEV-MVA-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Equine Encephalitis

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: Number of subjects reporting any serious adverse events (SAE)

  Number of subjects reporting any serious adverse events (SAE)

  within 7 months after vaccinations of subjects

Study Arms (3)

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.

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

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

Biological: MVA-BN-WEV Dose 3

Interventions

MVA-BN-WEV Dose 1 BIOLOGICAL

1 x 10\^7 Inf.U MVA-BN-WEV vaccine

MVA-BN-WEV Dose 1

MVA-BN-WEV Dose 2 BIOLOGICAL

1 x 10\^8 Inf.U MVA-BN-WEV vaccine

MVA-BN-WEV Dose 2

MVA-BN-WEV Dose 3 BIOLOGICAL

2 x 10\^8 Inf.U MVA-BN-WEV vaccine.

MVA-BN-WEV Dose 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Male and female subjects ≥18 and ≤50 years of age at screening (SCR).
• \. 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 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).
• \. Body mass index (BMI) ≥18.5 and ≤35.
• \. 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.
• \. Women of Childbearing Potential (WOCBP) must have a negative serum pregnancy test at SCR.
• \. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus.
• \. Troponin I within normal limits at SCR.

You may not qualify if:

• \. Pregnant or breast-feeding women.
• \. 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.
• \. 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.
• \. 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.
• \. 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 smallpox vaccination or vaccination with a poxvirus-based vaccine.
• \. Known or suspected previous alphavirus infections (Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV), Western Equine Encephalitis Virus (WEEV), Chikungunya).
• \. 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.
• \. 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 time period of 6 months before SCR).
• \. 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.
• \. Known allergy to eggs.
• \. 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 an inactivated vaccine within 14 days prior to first or after last trial vaccination.

Sponsors & Collaborators

• Bavarian Nordic: lead
• JPM CBRN Medical: collaborator

Study Sites (1)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

• 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.

  PMID: 38494412 DERIVED

MeSH Terms

Conditions

Encephalomyelitis, Equine

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalomyelitis; Infectious Encephalitis; Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Encephalitis, Arbovirus; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Carlos Fierro, MD

  JCCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: October 7, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)