A Phase 2 Trial in Healthy Adult Participants of the Recombinant MVA-BN-WEV Vaccine (NCT06899802) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Trial in Healthy Adult Participants of the Recombinant MVA-BN-WEV Vaccine
United States411 participantsStarted 2025-03-10
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Male and female participants ≥18 and ≤50 years of age at screening.
✓. 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 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.
✓. Body mass index (BMI) ≥18.5 and ≤35.
✓. Female participants should fulfil one of the following criteria:
✓. At least 1 year post-menopausal (amenorrhea \> 12 months) at screening.
✓. Will use contraceptives as outlined in inclusion criterion 6 from screening until 30 days after last vaccination.
Exclusion criteria
✕. Pregnant or breast-feeding women.
✕. 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.
What they're measuring
1
Optimal dose of MVA-BN-WEV vaccine in adult participants in terms of immunogenicity based on eastern equine encephalitis virus (EEEV)- and Venezuelan equine encephalitis virus (VEEV)-specific humoral immune responses to the MVA-BN-WEV vaccination.
Timeframe: 2 weeks after second vaccination.
2
Booster response of MVA-BN-WEV versus placebo in terms of immunogenicity based on EEEV- and VEEV- specific humoral immune responses to the MVA-BN-WEV vaccine.
✕. History of or active autoimmune disease; persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
✕. 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 alphavirus infections or previous vaccination (EEEV, VEEV, WEEV, Chikungunya).
✕. Known or suspected previous smallpox vaccination, vaccination with a poxvirus-based vaccine, or mpox infection.
✕. 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.
✕. Clinically significant mental disorder not adequately controlled by medical treatment.