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| ID | Type | Description | Link |
|---|---|---|---|
| 15-I-N071 | Other Identifier | NIH IRB Protocol ID number |
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Background:
- Ebola virus disease (EVD) affects many people in Liberia and other countries in West Africa. It is caused by the Ebola virus and makes people sick with fever, headache, vomiting, diarrhea, rash, and bleeding. About half the people with EVD die. There is no approved treatment for it. Researchers are studying two Ebola vaccines. The vaccines do not cause Ebola.
Objectives:
- To study the safety and efficacy of two Ebola vaccines.
Eligibility:
- Adults 18 and older who live in Liberia and are at risk for Ebola infection but have never had Ebola.
Design:
Ebola virus disease (EVD) in West Africa is spreading rapidly, and there is a critical need for a vaccine to prevent EVD. There are two candidate Ebola virus vaccines, the chimpanzee adenovirus 3 (ChAd3-EBO Z)-based vaccine and the Vesicular Stomatitis virus (VSVdeltaG-ZEBOV)-based vaccine. This study will evaluate both of these vaccines in a randomized, double-blind, controlled, 3-arm study in Liberia. Each vaccine will be compared against the same active control. Because there are limited data on the safety of these vaccines, the initial phase (phase 2) of the study will include the collection of more detailed data on safety and will define the immune response elicited by each vaccine in the first 600 volunteers. With the decline in new cases of Ebola virus infection the phase 3 component was no longer deemed to be feasible and, following safety, ethical and FDA approve/concurrence, the study was amended to a more robust, 1,500 person phase 2 design.
With the amendment to only a phasae 3 study the endpoint reverted to the phase 2 endpoint of safety and immunogenicity.
Participants aged 18 year and older will be enrolled at health clinics in Monrovia, Liberia over 4 months. A single dose of the assigned agent will be administered. Participants in phase 2 will undergo blood draw and assessment of adverse events (AEs) and signs and symptoms of Ebola infection at 1 week and 1 month after vaccination, and monthly assessment of AEs and signs and symptoms of Ebola thereafter. Participants in phase 3 will undergo monthly assessment of AEs and signs and symptoms of Ebola infection after vaccination. All participants will be followed for 8 to 12 months.
This clinical trial to evaluate vaccine efficacy will provide an accurate assessment of the benefits and risks associated with each candidate vaccine and inform policy on wider scale vaccination in other countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | ChAd3-EBO Z |
|
| 3 | Experimental | VSVG-ZEBOV |
|
| 1 | Placebo Comparator | Placebo (Saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSVG-ZEBOV | Biological | The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV) |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events. | Number of Participants Experiencing Serious Adverse Events in First 30 Days | One month |
| Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. | Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry | One month |
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The inclusion criteria for the study are broad reflecting the target population that would eventually receive an efficacious vaccine.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| H. Clifford Lane, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liberian Ministry of Health and Social Welfare | Monrovia | Liberia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21084112 | Background | Feldmann H, Geisbert TW. Ebola haemorrhagic fever. Lancet. 2011 Mar 5;377(9768):849-62. doi: 10.1016/S0140-6736(10)60667-8. | |
| 25372854 | Background | Chertow DS, Kleine C, Edwards JK, Scaini R, Giuliani R, Sprecher A. Ebola virus disease in West Africa--clinical manifestations and management. N Engl J Med. 2014 Nov 27;371(22):2054-7. doi: 10.1056/NEJMp1413084. Epub 2014 Nov 5. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ChAd3-EBO Z | ChAd3-EBO Z ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. |
| FG001 | VSVG-ZEBOV | VSVG-ZEBOV VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV) |
| FG002 | Placebo (Saline) | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ChAd3-EBO Z | ChAd3-EBO Z ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serious Adverse Events. | Number of Participants Experiencing Serious Adverse Events in First 30 Days | All Participants Randomized | Posted | Count of Participants | Participants | One month |
|
First 30 days after vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ChAd3-EBO Z | ChAd3-EBO Z ChAd3-EBO Z: The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Grandits | Division of Biostatistics, University of Minnesota | 612-626-9033 | grand001@umn.edu |
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|
| ChAd3-EBO Z | Biological | The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion. |
|
| Placebo | Biological |
|
| 22218691 | Background | Colloca S, Barnes E, Folgori A, Ammendola V, Capone S, Cirillo A, Siani L, Naddeo M, Grazioli F, Esposito ML, Ambrosio M, Sparacino A, Bartiromo M, Meola A, Smith K, Kurioka A, O'Hara GA, Ewer KJ, Anagnostou N, Bliss C, Hill AV, Traboni C, Klenerman P, Cortese R, Nicosia A. Vaccine vectors derived from a large collection of simian adenoviruses induce potent cellular immunity across multiple species. Sci Transl Med. 2012 Jan 4;4(115):115ra2. doi: 10.1126/scitranslmed.3002925. |
| 36208978 | Derived | Simon JK, Kennedy SB, Mahon BE, Dubey SA, Grant-Klein RJ, Liu K, Hartzel J, Coller BG, Welebob C, Hanson ME, Grais RF. Immunogenicity of rVSVDeltaG-ZEBOV-GP Ebola vaccine (ERVEBO(R)) in African clinical trial participants by age, sex, and baseline GP-ELISA titer: A post hoc analysis of three Phase 2/3 trials. Vaccine. 2022 Nov 2;40(46):6599-6606. doi: 10.1016/j.vaccine.2022.09.037. Epub 2022 Oct 5. |
| 32499064 | Derived | Antonello J, Grant-Klein RJ, Nichols R, Kennedy SB, Dubey S, Simon JK. Serostatus cutoff levels and fold increase to define seroresponse to recombinant vesicular stomatitis virus - Zaire Ebola virus envelope glycoprotein vaccine: An evidence-based analysis. Vaccine. 2020 Jun 26;38(31):4885-4891. doi: 10.1016/j.vaccine.2020.04.061. Epub 2020 Jun 1. |
| 29481881 | Derived | Logue J, Tuznik K, Follmann D, Grandits G, Marchand J, Reilly C, Sarro YDS, Pettitt J, Stavale EJ, Fallah M, Olinger GG, Bolay FK, Hensley LE. Use of the Filovirus Animal Non-Clinical Group (FANG) Ebola virus immuno-assay requires fewer study participants to power a study than the Alpha Diagnostic International assay. J Virol Methods. 2018 May;255:84-90. doi: 10.1016/j.jviromet.2018.02.018. Epub 2018 Feb 23. |
| 29020589 | Derived | Kennedy SB, Bolay F, Kieh M, Grandits G, Badio M, Ballou R, Eckes R, Feinberg M, Follmann D, Grund B, Gupta S, Hensley L, Higgs E, Janosko K, Johnson M, Kateh F, Logue J, Marchand J, Monath T, Nason M, Nyenswah T, Roman F, Stavale E, Wolfson J, Neaton JD, Lane HC; PREVAIL I Study Group. Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia. N Engl J Med. 2017 Oct 12;377(15):1438-1447. doi: 10.1056/NEJMoa1614067. |
| 28647166 | Derived | Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21. |
| VSVG-ZEBOV |
VSVG-ZEBOV VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV) |
| BG002 | Placebo (Saline) | Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Contact past month with someone who had Ebola | Count of Participants | Participants |
|
| Work involves contact with persons with Ebola | Count of Participants | Participants |
|
| HIV Positive | Count of Participants | Participants |
|
| Syphilis positive | Count of Participants | Participants |
|
| IgG antibody level (EU/mL) | Median | Inter-Quartile Range | EU/mL |
|
| Positive antibody response | Count of Participants | Participants |
|
| OG002 | Placebo (Saline) | Placebo |
|
|
|
| Primary | Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody. | Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry | Participants with 1-month antibody data without elevated antibody levels at entry | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | One month |
|
|
|
|
| 0 |
| 500 |
| 6 |
| 500 |
| 0 |
| 500 |
| EG001 | VSVG-ZEBOV | VSVG-ZEBOV VSVG-ZEBOV: The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV) | 0 | 500 | 6 | 500 | 0 | 500 |
| EG002 | Placebo (Saline) | Placebo | 1 | 500 | 8 | 500 | 0 | 500 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Pheumocystis jirovecii pheumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
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| <0.001 |
| Superiority |