Phase 2
N=421
A Study to Assess Safety, Tolerability, and Immunogenicity of Three Heterologus 2-dose Regimens of the Candidate Prophylactic Vaccines for Ebola in Healthy Adults
Ebola Viral Disease
Bottom Line
View on ClinicalTrials.gov: NCT02416453 ↗Enrolled (actual)
421
Serious AEs
3.8%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3) — 4; 6; 6; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MVA-BN-Filo (Biological); Ad26.ZEBOV (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unsolicited Adverse Events (Groups 1, 2 and 3) |
4; 6; 6; 62; 6; 52 | — |
| PRIMARY Number of Participants With Serious Adverse Events (Groups 1, 2 and 3) |
0; 1; 0; 2; 0; 4 | — |
| PRIMARY Number of Participants With Immediate Reportable Events (Groups 1, 2 and 3) |
0; 0; 0; 0; 0; 2 | — |
| PRIMARY Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3) |
4; 5; 8; 46; 2; 49 | — |
| PRIMARY Number of Participants With Solicited Local Adverse Events (Groups 1, 2 and 3) |
4; 5; 8; 46; 2; 49 | — |
| PRIMARY Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3) |
6; 5; 5; 42; 5; 36 | — |
| PRIMARY Number of Participants With Solicited Systemic Adverse Events (Groups 1, 2 and 3) |
6; 5; 5; 42; 5; 36 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events (Group 4) |
6; 1 | — |
| SECONDARY Number of Participants With Serious Adverse Events (Group 4) |
2; 0 | — |
| SECONDARY Number of Participants With Immediate Reportable Events (Group 4) |
0; 0 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (Group 4) |
8; 0 | — |
| SECONDARY Number of Participants With Solicited Systemic Adverse Events (Group 4) |
11; 1 | — |
| SECONDARY 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) (Groups 1, 2 and 3) |
4627; NA; 10131; NA; 11312; NA | — |
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of 3 vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens.
Eligibility Criteria
Inclusion Criteria
- Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
- Must be healthy on the basis of clinical laboratory tests performed at Screening. If the results of the laboratory screening tests are outside the 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
- Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal (greater than [>] 45 years of age with amenorrhea for at least 2 years or lesser than or equal to [ 40 international unit per milliliter [IU/L]); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
- Woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
- Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to screening must be willing to use condoms for sexual intercourse beginning prior to enrollment
Exclusion Criteria
- Having received any candidate Ebola vaccine
- Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
- Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA-) based vaccine in the past
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines including known allergy to egg, egg products and aminoglycosides
- Presence of acute illness or temperature greater than or equal to 38.0 C on Day 1
Data sourced from ClinicalTrials.gov (NCT02416453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.