Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines … (NCT02598388) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
United States, Kenya, Mozambique578 participantsStarted 2015-12-10
Plain-language summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and in HIV-infected adults.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination and vital signs performed at Screening
* Participant must be healthy on the basis of clinical laboratory tests and electrocardiogram (ECG) (only in participants \>50 years) performed at Screening. If the results of the laboratory screening tests and ECG are outside the institutional normal reference ranges, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
* A woman of childbearing potential must have a negative urine β-human chorionic gonadotropin \[beta-hCG\] pregnancy test at Screening and a negative urine \[beta-hCG\] pregnancy test immediately prior to each study vaccine administration
* A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to dose 1 vaccination until at least 3 months after the dose 2 vaccination, unless a vasectomy was performed more than 1 year prior to Screening
* Participant must pass the test of understanding (TOU)
* Additional Inclusion Criteria for HIV-infected participants a) participants must have a positive HIV-1 and/or -2 serology test within 6 months of screening, including the day of screening; b) participants must have a Screening CD4+ cell count \>200 cells/m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events
Timeframe: Up to 28 days post each dose (up to Day 43)
2
Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events
Timeframe: Up to 28 days post dose 2 visit (up to Day 57)
3
Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to 1 year post dose 2 (up to Day 380)
4
Part 2 (Group 1): Number of Participants With SAEs
Timeframe: Up to 1 year post dose 2 (up to Day 394)
5
Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)
Timeframe: Up to 1 year post dose 2 (up to Day 380)
6
Part 2 (Group 1): Number of Participants With IREs
Timeframe: Up to 1 year post dose 2 (up to Day 394)
7
Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination
Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
Timeframe: 7 days post dose 2 (up to Day 22)
9
Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination
Timeframe: 7 days post dose 2 (up to Day 36)
10
Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination
Timeframe: 7 days post dose 1 (up to Day 8)
11
Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
Timeframe: 7 days post dose 2 (up to Day 22)
12
Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination
Timeframe: 7 days post dose 2 (up to Day 36)
13
Part 1, Part 2 (Group 2): Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA)
Timeframe: 21-days post dose 2 (up to Day 36)
14
Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA