The purpose of this study is to compare the humoral immune response induced by 3 different batches of Ad26.ZEBOV as measured by enzyme - linked immunosorbent assay (ELISA) against the Ebola virus (EBOV) GP (Glycoprotein) at 56 days post prime.
This is a randomized, double - blind, placebo - controlled, parallel - group, multicenter, Phase 3 study to evaluate the immunogenic equivalence of a heterologous prime - boost regimen using 3 different batches of Ad26.ZEBOV in healthy adult participants. The study consists of a screening period of up to 6 weeks, a vaccination period in which participants will be vaccinated at baseline (Day 1), followed by a boost vaccination on Day 57, and a post-vaccination phase until 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
329
Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5\*10\^10 viral particles on Day 1
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Melbourne, Florida, United States
Unnamed facility
Peoria, Illinois, United States
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Time frame: At 56 days post prime vaccination
Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein enzyme-linked immunosorbent assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Time frame: At Days 1, 29 post prime dose and at days 21, 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time frame: Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Time frame: Up to 42 days post boost vaccination
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Continuous throughout the duration of study (Up to 180 Days post boost vaccination)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1\*10\^8 Infectious Unit \[Inf. U.\] once on Day 57.
One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.
Unnamed facility
Mishawaka, Indiana, United States
Unnamed facility
Rockville, Maryland, United States