Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
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ClinicalTrials.gov Identifier: NCT02598388 |
Recruitment Status :
Completed
First Posted : November 5, 2015
Last Update Posted : December 13, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hemorrhagic Fever, Ebola | Biological: Ad26.ZEBOV Biological: MVA-BN-Filo Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 578 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Observer-blind, Placebo-controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo |
Actual Study Start Date : | December 10, 2015 |
Actual Primary Completion Date : | December 12, 2018 |
Actual Study Completion Date : | December 12, 2018 |
Arm | Intervention/treatment |
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Experimental: Part 1 (US Participants)
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
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Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles). Biological: MVA-BN-Filo One 0.5 mL IM injection of (1x10*8 infectious units). Biological: Placebo One 0.5 mL IM injection of 0.9 percent (%) saline. |
Experimental: Part 2 Group 1 (African Participants)
Participants will receive Ad26.ZEBOV or placebo on Day 1 followed by MVA-BN-Filo or placebo on Day 29.
|
Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles). Biological: MVA-BN-Filo One 0.5 mL IM injection of (1x10*8 infectious units). Biological: Placebo One 0.5 mL IM injection of 0.9 percent (%) saline. |
Experimental: Part 2 Group 2 (African Participants)
Participants will receive MVA-BN-Filo or placebo on Day 1 followed by Ad26.ZEBOV or placebo on Day 15.
|
Biological: Ad26.ZEBOV
One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles). Biological: MVA-BN-Filo One 0.5 mL IM injection of (1x10*8 infectious units). Biological: Placebo One 0.5 mL IM injection of 0.9 percent (%) saline. |
- Number of Participants With Adverse Events [ Time Frame: Up to Day 42 post-dose 2 visit ]
- Number of Participants With Serious Adverse Events [ Time Frame: Continuous throughout the duration of the study (up to 1 year post dose 2 visit +/- 1 month) ]
- Number of Participants with Solicited Local and Systemic Adverse Events [ Time Frame: Up to 7 days after each study vaccination ]
- Ebola Virus Glycoprotein (EBOV GP)-specific Antibody Concentrations Measured by an Ezyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Up to day 21 after dose 2 vaccination ]
- Comparison of Safety and Tolerability of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN- Filo/Ad26.ZEBOV Regimens Between Healthy and HIV-Infected Adults [ Time Frame: Up to 1 year post dose 2 ]The comparison will be made on the basis of treatment emergent adverse events as well as comparison of the solicited local and systemic adverse events for tolerability.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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/microliter (mcL); c) in part 1, all participants must be on a stable highly active antiretroviral therapy (HAART) regimen for 4 weeks prior to Screening, in part 2 participants with screening CD4+ cell count <350 cells/mcL must also be on a stable HAART regimen for 4 weeks prior to Screening
Exclusion Criteria:
- Has received any candidate Ebola vaccine
- Diagnosed with Ebola virus disease, or prior exposure to EBOV, including travel to epidemic Ebola areas less than 1 month prior to Screening
- Has received any experimental candidate Ad26- or MVA-based vaccine in the past or received any other investigational drug or investigational vaccine or used an invasive investigational medical device within 3 months prior to Screening
- Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products
- Presence of significant conditions (eg, history of seizure disorders, (auto)immune disease or deficiency, any spleen disease, active malignancy, ongoing tuberculosis treatment, other systemic infections) or clinically significant findings during screening of medical history, ECG (only in participants >50 years), physical examination, vital signs or laboratory testing for which, in the opinion of the investigator, participation would not be in the best interest of the participants (eg, compromise the safety or well-being) or that could prevent, limit, or confound the protocol-specified assessments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598388
United States, Maryland | |
Silver Spring, Maryland, United States | |
Kenya | |
Kericho, Kenya | |
Kisumu, Kenya | |
Mozambique | |
Maputo, Mozambique | |
Nigeria | |
Abuja, Nigeria | |
Tanzania | |
Mbeya, Tanzania | |
Uganda | |
Kampala, Uganda |
Study Director: | Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. |
Responsible Party: | Janssen Vaccines & Prevention B.V. |
ClinicalTrials.gov Identifier: | NCT02598388 |
Other Study ID Numbers: |
CR108062 VAC52150EBL2003 ( Other Identifier: Janssen Vaccines & Prevention B.V. ) |
First Posted: | November 5, 2015 Key Record Dates |
Last Update Posted: | December 13, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Device Product: | No |
Healthy Vaccine Ebola viruses Ebola virus disease (EVD) Filoviruses Hemorrhagic fever |
Monovalent vaccine Human adenovirus serotype 26 (Ad26) encoding the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV) Modified Vaccinia Virus Ankara - Bavarian Nordic (MVA-BN) Filo-vector Safety Immunogenicity |
Hemorrhagic Fever, Ebola Hemorrhagic Fevers, Viral RNA Virus Infections |
Virus Diseases Filoviridae Infections Mononegavirales Infections |