The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
974
Participants will receive IM injection (0.5 mL) of Ad26.ZEBOV as Dose 1 (5\*10\^10 vp, Lot A, B, and C) on Day 1 (Groups 1, 2, 3 and 5) and an Ad26.ZEBOV booster dose on Day 177 (Group 5).
Participants will receive IM injection (0.5 mL) of MVA-BN-Filo as Dose 2 (1\*10\^8 Inf U, Lot 1, 2, 3 and 5) on Day 57.
Participants will receive IM injection (0.5 mL) of placebo (0.9 % saline) as Dose 1 on Day 1, followed by placebo as Dose 2 on Day 57 (Groups 4 and 6) and a booster of matching placebo on Day 177 (Group 6).
Coastal Clinical Research, Inc
Mobile, Alabama, United States
Clinical Research Consortium, an AMR company
Tempe, Arizona, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
The Center For Pharmaceutical Research
Kansas City, Missouri, United States
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21 Days Post Vaccination 2
Antibody GMCs against the EBOV GP as measured by ELISA at 21 days post Vaccination 2 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the lower limit of quantification (LLOQ) of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Time frame: 21 Days Post Vaccination 2 (Day 78)
Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against the Ebola Virus Glycoprotein (EBOV GP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 56 Days Post Vaccination 1
Antibody GMCs against the EBOV GP as measured by ELISA at 56 days post Vaccination 1 were reported. GMCs of antibodies binding to EBOV GP using ELISA were reported and were measured in ELISA units per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using ELISA to determine humoral responses following vaccination. For ELISA binding antibody responses, values below the LLOQ of 36.11 EU/mL were imputed with half of the LLOQ prior to the computation of the GMCs.
Time frame: 56 Days Post Vaccination 1 (Day 57)
Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post vaccination. Solicited local AEs were injection site pain/tenderness, erythema, induration/swelling, itching, pruritis at the vaccination site.
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Clinical Research Consortium, an AMR company
Las Vegas, Nevada, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States
Alliance for Multispeciality Research
Norfolk, Virginia, United States
Time frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature greater than or equal to (\>=) 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination 1 and 2 (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia, arthralgia, chills, and fever.
Time frame: Until 7 Days after Vaccination 1 on Day 1 (Up to Day 8); Until 7 Days after Vaccination 2 on Day 57 (Up to Day 64)
Number of Participants With Unsolicited Adverse Events (AEs) Until 28 Days After Vaccination 1 and 2
An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Time frame: Until 28 Days After Vaccination 1 on Day 1 (Up to Day 29); until 28 days after Vaccination 2 on Day 57 (Up to Day 85)
Number of Participants With Serious Adverse Events (SAEs)
SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Day 1 up to Day 237 for Groups 1, 2, 3, 4, and up to Day 537 for Groups 5 and 6