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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
411
MVA-mBN396 (common name MVA-BN-WEV vaccine), is a highly attenuated, live recombinant virus based on the licensed viral vector MVA-BN, provided as a liquid frozen formulation. It is administered as an intramuscular injection.
Tris-Buffered Saline (TBS) (placebo) is a clear liquid, free from visible extraneous particles. TBS is acceptable for use as a diluent and for intramuscular injection.
Benchmark Research
Sacramento, California, United States
Lifeline Primary Care, Inc. / CCT Research
Lilburn, Georgia, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
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.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measured by ELISA against EEEV and VEEV at 2 weeks after the second trial vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measured by PRNT against EEEV and VEEV at 2 weeks after the second trial vaccination.
Time frame: 2 weeks after second vaccination.
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.
The participants' serum binding antibody titers of MVA-BN-WEV vaccine as measure by ELISA against EEEV and VEEV at 2 weeks after the third vaccination, and the participants' serum neutralizing antibody titers of MVA-BN-WEV vaccine as measure by PRNT against EEEV and VEEV at 2 weeks after the third vaccination.
Time frame: 2 weeks after third vaccination.
Safety and reactogenicity of the MVA-BN-WEV vaccine and placebo in terms of solicited and unsolicited AEs in participants throughout the trial.
Participants reporting: Stage 1 and 2: * Any SAE, regardless of relationship, throughout the trial (first vaccination through the end of the trial). * Any AESI regardless of relationship from first vaccination through the end of the trial. Stage 1: • Any grade 3 or higher solicited or unsolicited AEs assessed as related to trial vaccine from first vaccination through end of active treatment period stage 1. Stage 2: • Any grade 3 or higher solicited or unsolicited AEs assessed as related to trial vaccine from third vaccination through end of active treatment period stage 2.
Time frame: Duration of trial (approximately 19 mon) for SAE or AESI or during active trial period (defined as the period from 1st vaccination up to and including the end of active trial period for stage 1 (4 wks after 2nd vaccination)/stage 2 (4 wks after booster).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Versailles Family Medicine, PLLC/CCT Research
Versailles, Kentucky, United States
Benchmark Research
Kenner, Louisiana, United States
Jefferson City Medical Group / Avacare
Jefferson City, Missouri, United States
Clay-Platte Family Medicine, P.C./CCT Research
Kansas City, Missouri, United States
Papillion Research Center/CCT Research
Papillion, Nebraska, United States
Benchmark Research
San Angelo, Texas, United States
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine.
* Serum binding antibody titers against WEEV as determined by ELISA, 2 weeks after second vaccination. * Seroconversion response in terms of serum binding antibody titers against WEEV, EEEV, and VEEV as determined by ELISA, 2 weeks after second vaccination. * Serum neutralizing antibody titers against WEEV, and VV as determined by PRNT, 2 weeks after second vaccination. * Seroconversion response in terms of neutralizing antibody titers against WEEV, EEEV, VEEV, and VV as determined by PRNT, 2 weeks after second vaccination.
Time frame: 2 weeks after second vaccination.
WEEV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo and the VV-specific humoral immune responses to the MVA-BN-WEV vaccine versus placebo.
* Serum binding antibody titers against WEEV as determined by ELISA, 2 weeks after third vaccination. * Serum neutralizing antibody titers against WEEV, and VV as determined by PRNT, 2 weeks after third vaccination.
Time frame: 2 weeks after third vaccination.