Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)
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|ClinicalTrials.gov Identifier: NCT02283099|
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Fever, Ebola||Biological: rVSVΔ-ZEBOV-GP||Phase 1|
This study is being conducted to assess safety and immunogenicity of an experimental ebola vaccine.
An outbreak due to the Ebola Zaire (ZEBOV) strain of unprecedented magnitude and scope and with a high mortality continues to spread across West Africa. No vaccine is currently licensed.
The specific opportunity at hand with rVSVΔG-ZEBOV-GP (BPSC1001) is to achieve long-lasting protective immunity to ZEBOV on a time scale of weeks in humans upon a single-shot vaccination, offering a discrete benefit over prime-boost vaccination protocols. The current outbreak represents a global health emergency and the need for access to therapeutic intervention and vaccines is paramount.
The vaccine investigated in this study might provide a critical tool to suppress future out-breaks of EVD in areas at risk.
This study is 1 of 4 clinical trials currently conducted as part of the WHO-led VEBCON consortium, aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine candidate to allow optimized rapid decisions on dose and safety.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Single Center, Dose Escalation Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Single Ascending Dose of the Ebola Virus Vaccine rVSVΔG-ZEBOV-GP (BPSC1001)|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: rVSVΔ-ZEBOV-GP (BPSC1001)
Subjects will be allocated to three cohorts of 10 subjects each receiving one single vaccine injection administered as an i.m. injection.
single dose of rVSVΔ-ZEBOV-GP (3x10^6 pfu, 2x10^7 pfu or 3x10^5)
Other Name: BPSC1001
- The number of adverse events associated with the rVSVΔ-ZEBOV-GP (BPSC1001) vaccine will be collected and measured [ Time Frame: Vaccination (day 0) to day 180 ]
- ZEBOV-GP-specific antibody responses [ Time Frame: Vaccination (day 0) to day 180 ]Humoral immunity: Magnitude of ZEBOV-GP-specific antibody responses as assayed by ELISA in a centralized laboratory.
- To evaluate vaccine viremia and excretion [ Time Frame: Vaccination (day 0) to day 28 ]Vaccine viremia and viral shedding: concentration of rVSV in peripheral blood, urine and saliva as detected by qRT-PCR
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): NCT02283099
|CTC North GmbH & Co. KG|
|Hamburg, Germany, 20246|
|Study Director:||Marylyn M. Addo, MD||Universitätsklinikum Hamburg-Eppendorf|