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| Name | Class |
|---|---|
| Infectious Disease Service, CHUV, Lausanne | UNKNOWN |
| Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | OTHER |
| University of Lausanne Hospitals | OTHER |
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The objective of this trial is to assess in healthy adults the safety and reactogenicity of a new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the immunogenicity of the candidate vaccine and find the most suitable dose for further deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of possibly exposed volunteers owning to organisations such as "Médecins sans frontières" and susceptible to be deployed in the outbreak zone (named as "possibly exposed volunteers"). The other volunteers will be adults with no planned travels to the epidemic zone (named as "not exposed volunteers"). The first group will be randomly allocated to two different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp). The second group will be randomly allocated to three different groups (low dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10 vp or placebo = single injection of vaccine diluent). The design will be double-blind. Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deployed volunteers - Group 1 | Experimental | Low dose cAd3-EBOZ (2.5x10e10 vp) |
|
| Deployed volunteers - Group 2 | Experimental | High dose cAd3-EBOZ (5x10e10 vp) |
|
| Not deployed volunteers - Group 3 | Experimental | Low dose cAd3-EBOZ (2.5x10e10 vp) |
|
| Not deployed volunteers - Group 4 | Experimental | High dose cAd3-EBOZ (5x10e10 vp) |
|
| Not deployed volunteers - Group 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cAd3-EBOZ vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local and systemic reactogenicity signs and symptoms | Solicited local signs and symptoms include: pain at injection site; erythema at injection site; swelling at injection site. They will be assessed according to a preestablished scale (grade 1 to 3). Solicited systemic signs and symptoms include: fever; tachycardia; bradycardia; systolic hypertension; distolic hypertension; systolic hypotension. They will be assessed according to a preestablished scale (grade 1 to 3). | Daily for 7 days following the vaccination |
| Unsolicited adverse events of all severities | Unsolicited adverse events will be assessed according to a severity grading scale (grade 1 to 3). | Through 28 days after the vaccination |
| Change from baseline for safety laboratory measures | Safety laboratory measures include: hemoglobin; white blood cells count; neutrophil count; lymphocyte count; platelets; total bilirubin; alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase; creatinine; urea; sodium; potassium; partial thromboplastin time (aPTT). They will be assessed according to a severity grading scale (grade 1 to 3). | Through 6 months after the vaccination |
| Occurrence of serious adverse events and suspected unexpected serious adverse reactions | SAE are defined as AE that result in any of the following outcomes, whether or not considered related to the study intervention:
A SUSAR is a suspected unexpected serious adverse reaction thought to be possibly, probably or definitely related to an IMP. No category of SAE has been defined as 'expected'. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody responses as measured by ELISA (anti-EBOZ immunoglobulins titers) and by antigen-specific neutralization assays | Through 6 months after the vaccination | |
| T cell immune responses as measured by ex-vivo ELISPOT | Through 6 months after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| T cell immune responses as measured by intracellular cytokine staining assays (ICS) | Through 6 months after the vaccination | |
| T cell immune responses as measured by 6-day culture cytokine production by Multiplex and flow cytometry | Through 6 months after the vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blaise Genton, MD PhD | CHUV and PMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Unit Lausanne | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26725450 | Derived | De Santis O, Audran R, Pothin E, Warpelin-Decrausaz L, Vallotton L, Wuerzner G, Cochet C, Estoppey D, Steiner-Monard V, Lonchampt S, Thierry AC, Mayor C, Bailer RT, Mbaya OT, Zhou Y, Ploquin A, Sullivan NJ, Graham BS, Roman F, De Ryck I, Ballou WR, Kieny MP, Moorthy V, Spertini F, Genton B. Safety and immunogenicity of a chimpanzee adenovirus-vectored Ebola vaccine in healthy adults: a randomised, double-blind, placebo-controlled, dose-finding, phase 1/2a study. Lancet Infect Dis. 2016 Mar;16(3):311-20. doi: 10.1016/S1473-3099(15)00486-7. Epub 2015 Dec 23. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2018 | |
| Reset | Dec 5, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2018 | Dec 5, 2018 |
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Swiss Tropical & Public Health Institute | OTHER |
| University of Lausanne | OTHER |
| GlaxoSmithKline | INDUSTRY |
| World Health Organization | OTHER |
| Immunology and Allergy Service, CHUV, Lausanne | UNKNOWN |
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| Placebo (for cAd3-EBOZ vaccine) | Biological | Diluent |
|
| Through 6 months after the vaccination |
| HLA typing | On Day 0 (day of vaccination) |
| Vaccine-induced mRNA expression profiles (transcriptomics) | Through 28 days after the vaccination |
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |