Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-24 @ 5:52 AM
Study NCT ID:
NCT02325050
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
Sponsor:
Janssen Vaccines & Prevention B.V.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Placebo-Controlled, Observer-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Heterologous and Homologous Prime-Boost Regimens Using MVA-BN-Filo® and Ad26.ZEBOV Administered in Different Doses, Sequences and Schedules in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
Detailed Description:
This study consists of 3 parts: the first and third part with standard doses and the second part with higher doses. All parts are randomized, placebo-controlled, observer-blind to evaluate the safety, tolerability and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered in different doses, sequences and schedules to healthy adult participants. The study consists of a screening period of up to 28 days, a vaccination period in which participants will be vaccinated at baseline (Day 1) followed by a boost on Day 15, 29, or 57, and third vaccine 1-year post-prime (3rd vaccination is optional for subjects in groups 1-8). The total duration of the study will be about 1 year for participants who wiil receive boost vaccine and about 3 months for participants who will receive placebo and 2 year for participants who will receive a 3rd dose. Safety will be monitored during the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| VAC52150EBL1002 | OTHER | Janssen Vaccines & Prevention B.V. | View |