International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03072030|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2017
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus Disease Prevention||Biological: GamEvac-Combi (vaccine) Biological: Placebo||Phase 4|
This clinical trial is designed as a double blind randomized placebo-controlled study to evaluate immunogenicity of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose.
The study includes three periods: screening, administration of the investigated product and follow-up. Vaccine will be administered to groups of volunteers (each group will include not more than 40 volunteers at a time; a new group of volunteers cannot be hospitalized before the earlier vaccinated volunteers are discharged from the hospital. In total, 8 visits will be held, including a screening visit; two of the visits will take place during the inpatient stage and six - during the outpatient observation.
Study design in the both facilities will be the same for all volunteers, except that the biomaterial collected for immunogenicity evaluation from volunteers included in the study in the Russian Federation will be delivered directly to the testing laboratory; biomaterial from volunteers included in the study in the Republic of Guinea will undergo primary specimen processing, be frozen and stored under the assigned temperature conditions in the research center and, as biomaterial is accumulated, it will be transported in a fridge to the study site.
In addition, laboratory tests for such concomitant infectious diseases, as yellow fever, Denge fever, Ebola and Marburg virus diseases will be carried out for epidemiological indications (i.e. in the endemic regions if disease cases are reported).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This clinical trial is designed as a double blind randomized placebo-controlled study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||01 - GamEvac-Combi-2016 " International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi - Combined Vector-Based Vaccine Against Ebola Virus Disease, 0.5 ml+0.5 ml/Dose "|
|Actual Study Start Date :||August 3, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
Experimental: Active Drug Group
1900 volunteers will be immunized with vaccine GamEvac-Combi They will receive product twice according to the following dosing regimen: on Day 1 (component A) and Day 21 of the study (component B) in the dose of 0.5 ml
Biological: GamEvac-Combi (vaccine)
Placebo Comparator: Placebo Drug Group
100 volunteers will be immunized with placebo They will receive product twice according to the following dosing regimen: on Day 1 (placebo - component A) and Day 21 of the study (placebo- component B) in the dose of 0.5 ml
- determination of immunity duration by ELISA method [ Time Frame: the total Time Frame is 12 month after the vaccination ]immunity duration determination by ELISA method includes time points in which the assessment of the immunity response (antibody titer) should be provided (21, 28, 42 days and 3, 6, 12 months after the vaccination respectively)
- assessment of antigen-specific cell-mediated immune response [ Time Frame: on days 0 and 28 ]determination of specific T-cell- mediated response to Ebola virus proteins vs. baseline values and placebo
- determination of immunity duration in virus neutralization reaction [ Time Frame: on days 0 and 42 ]Determination of the immunity duration will be provided by the assessment of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
- safety and tolerability [ Time Frame: through study completion, an average of 1 year ]Incidence in the healthy volunteers vital parameters changes and the occurrence of systemic and local post-vaccination reactions in comparison with placebo; reviewing its impact on the vital parameters in healthy volunteers (systolic and diastolic blood pressure, heart rate, respiration rate, body temperature) and the occurrence of systemic and local post-vaccination reactions in comparison with placebo
- epidemiological effectiveness of vaccination [ Time Frame: through study completion, an average of 1 year" ]2. Where possible, to evaluate epidemiological effectiveness of vaccination based on the follow-on morbidity indicators of immunized and non-immunized individuals, manifestations of the epidemiological process in time and space
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): NCT03072030
|Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia|
|Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department|
|Moscow, Russian Federation|
|Principal Investigator:||Sylla Ali Lathyr||physician administrator|
|Principal Investigator:||Marina Rusanova, MD, PhD||doctor of infectious department|