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A Study of 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN-Filo in Adult Participants

NCT04228783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 974

Last updated 2025-05-25

Study results available
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Summary

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.

Conditions

  • Ebola

Interventions

BIOLOGICAL

Ad26.ZEBOV

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).

BIOLOGICAL

MVA-BN-Filo

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.

BIOLOGICAL

Placebo

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).

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2022-04-25
Completion
2022-04-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228783 on ClinicalTrials.gov