International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi

• ClinicalTrials.gov Identifier: NCT03072030
• Recruitment Status: Completed
• First Posted: March 7, 2017
• Last Update Posted: August 25, 2020
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Collaborator: CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )
• Information provided by (Responsible Party): Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Tracking Information

• First Submitted Date: February 20, 2017
• First Posted Date: March 7, 2017
• Last Update Posted Date: August 25, 2020
• Actual Study Start Date: August 3, 2017
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2018)

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)

Original Primary Outcome Measures (submitted: March 1, 2017)

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 (28, 42 days and 3, 6, 12 months after the vaccination respectively)

Current Secondary Outcome Measures (submitted: March 1, 2017)

• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 1, 2017)

• 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
• 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 "
• Brief Summary: The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus Disease, 0.5 ml+0.5 ml/dose

Detailed Description

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
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This clinical trial is designed as a double blind randomized placebo-controlled study

Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Condition

• Ebola Virus Disease
• Prevention

Intervention

• Biological: GamEvac-Combi (vaccine)
  vaccination
• Biological: Placebo
  vaccination

Study Arms

• 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
  Intervention: 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
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2017): 2000
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2020
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Males and females within the age range from 18 to 60 years;
• written informed consent;
• absence of acute infectious diseases/relapses of chronic diseases at the time of vaccine administration and 7 days prior to the vaccination;
• absence of severe allergic diseases in the medical history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum disease)
• no serious post-vaccination complications in patient's history following the earlier administration of immunobiological products
• negative blood or urine test for pregnancy (for child-bearing age females) not more than 24 hours prior to the administration of the first dose of investigated product;
• absence of concomitant illnesses, especially dangerous or endemic for a particular region, proved by laboratory and/or clinical methods (malaria, yellow fever, Denge fever, Ebola or Marburg virus disease, poliomyelitis).
• negative results of HIV, hepatitis B and C and syphilis tests.
• adequate contraception for females and males of reproductive age.
• negative results of urine test for narcotic drug residues;
• negative result of breath alcohol test (in the expired air sample)
• absence of haematological malignancies
• absence of malignant neoplasms

Exclusion Criteria:

• - volunteer involvement in another study over the last 90 days;
• any immunization with vaccine over the last 30 days;
• symptoms of acute respiratory diseases within the last 7 days;
• administration of immunoglobulins or other blood products; taking immunosuppressive medications and/or immunomodulating agents over the last 3 months;
• pregnancy or breast feeding;
• exacerbation of allergic diseases, previous history of anaphylactic reactions or angioneurotic edema;
• previous history of hypersensitivity or allergic reactions to the administration of any vaccines;
• allergic reactions to the vaccine components;
• presence of a concomitant illness which might affect the evaluation of study results: active tuberculosis form, chronic liver and kidney diseases, serious thyroid dysfunction or other endocrine disorders (diabetes mellitus), severe hematopoietic diseases, epilepsy and other CNS disorders, myocardial infarction in the medical history, myocarditis, endocarditis, pericarditis, ischemic heat disease and other illnesses which, in opinion of the investigator, make patient ineligible for study enrollment or may affect the course of the study.
• blood donation (450 ml or more of blood or plasma) less than 2 months prior the study commencement date.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Guinea, Russian Federation

Administrative Information

• NCT Number: NCT03072030
• Other Study ID Numbers: 01 - GamEvac-Combi-2016; http://grls.rosminzdrav.ru ( Registry Identifier: the Ministry of Health of the Russian Federation )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Study Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Collaborators: CREMS (Centre de Recherche Epidémiologie, Microbiologie et Soins médicaux )

Investigators

• Principal Investigator: Sylla Ali Lathyr; physician administrator
• Principal Investigator: Marina Rusanova, MD, PhD; doctor of infectious department

• PRS Account: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Verification Date: July 2019