RECRUITING

A Phase 2 Trial in Healthy Adult Participants of the Recombinant MVA-BN-WEV Vaccine

Conditions

Encephalitis vaccine equine encephalitis healthy participants phase 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-10

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06899802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and female participants ≥18 and ≤50 years of age at screening. 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 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. 4. Body mass index (BMI) ≥18.5 and ≤35. 5. Female participants should fulfil one of the following criteria: 1. At least 1 year post-menopausal (amenorrhea \> 12 months) at screening. 2. Surgically sterile (bilateral oophorectomy, bilateral tubal ligation, hysterectomy) 3. Will use contraceptives as outlined in inclusion criterion 6 from screening until 30 days after last vaccination. 6. 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). 7. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus.	1. Pregnant or breast-feeding women. 2. 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. 3. History of or active autoimmune disease; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. 4. 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. 5. Known or suspected previous alphavirus infections or previous vaccination (EEEV, VEEV, WEEV, Chikungunya). 6. Known or suspected previous smallpox vaccination, vaccination with a poxvirus-based vaccine, or mpox infection. 7. 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. 8. Clinically significant mental disorder not adequately controlled by medical treatment. 9. Active or recent history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the period of 6 months before screening). 10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, quail proteins. 11. History of anaphylaxis or severe allergic reaction to any vaccine. 12. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to first or after last trial vaccination. 13. 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. 14. 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). 15. 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. 16. Post organ transplant participants whether or not receiving chronic immunosuppressive therapy. 17. 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). 18. 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. 19. 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). 20. 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. 21. Association with Bavarian Nordic as staff, contractors, agents, or business partners or any financial interest in the outcome of the trial. 22. Federal employees and active-duty military personnel.

Inclusion Criteria

Exclusion Criteria

1. Male and female participants ≥18 and ≤50 years of age at screening.
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 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.
4. Body mass index (BMI) ≥18.5 and ≤35.
5. Female participants should fulfil one of the following criteria:
1. At least 1 year post-menopausal (amenorrhea \> 12 months) at screening.
2. Surgically sterile (bilateral oophorectomy, bilateral tubal ligation, hysterectomy)
3. Will use contraceptives as outlined in inclusion criterion 6 from screening until 30 days after last vaccination.
6. 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).
7. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody to hepatitis C virus.

1. Pregnant or breast-feeding women.
2. 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.
3. History of or active autoimmune disease; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
4. 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.
5. Known or suspected previous alphavirus infections or previous vaccination (EEEV, VEEV, WEEV, Chikungunya).
6. Known or suspected previous smallpox vaccination, vaccination with a poxvirus-based vaccine, or mpox infection.
7. 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.
8. Clinically significant mental disorder not adequately controlled by medical treatment.
9. Active or recent history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the period of 6 months before screening).
10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, quail proteins.
11. History of anaphylaxis or severe allergic reaction to any vaccine.
12. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to first or after last trial vaccination.
13. 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.
14. 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).
15. 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.
16. Post organ transplant participants whether or not receiving chronic immunosuppressive therapy.
17. 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).
18. 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.
19. 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).
20. 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.
21. Association with Bavarian Nordic as staff, contractors, agents, or business partners or any financial interest in the outcome of the trial.
22. Federal employees and active-duty military personnel.

Contacts and Locations

Study Contact

Nina M. Stark, MS

CONTACT

984-243-5000

info@bavarian-nordic.com

Bernard H. Hoet, MD

CONTACT

984-243-5000

beho@bavarian-nordic.com

Principal Investigator

Carlos A. Fierro, MD

PRINCIPAL_INVESTIGATOR

Johnson County Clin-Trials

Study Locations (Sites)

Benchmark Research

Sacramento, California, 95864

United States

Lifeline Primary Care, Inc. / CCT Research

Lilburn, Georgia, 30047

United States

Johnson County Clin-Trials

Lenexa, Kansas, 66219

United States

Versailles Family Medicine, PLLC/CCT Research

Versailles, Kentucky, 40383

United States

Benchmark Research

Metairie, Louisiana, 70006

United States

Jefferson City Medical Group / Avacare

Jefferson City, Missouri, 65109

United States

Clay-Platte Family Medicine, P.C./CCT Research

Kansas City, Missouri, 64151

United States

Papillion Research Center/CCT Research

Papillion, Nebraska, 68046

United States

Benchmark Research

San Angelo, Texas, 76904

United States

Collaborators and Investigators

Sponsor: Bavarian Nordic

Carlos A. Fierro, MD, PRINCIPAL_INVESTIGATOR, Johnson County Clin-Trials

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

vaccine
equine encephalitis
healthy participants
phase 2

Additional Relevant MeSH Terms

Encephalitis