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

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201702002053400
• Date of registration: 17/02/2017
• Prospective Registration: Yes
• Primary sponsor: Federal Research Centre for Epidemiology and Microbiology named after N.F. Gamaleya
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/06/2017
• Target sample size: 2000
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2053
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Guinea

Contacts

• Name: Elena Sokolova
• Affiliation: Clinical Trial Assistant

• Name: Denis Logunov
• Affiliation: Deputy Scientific Director, Head of Laboratory

Key inclusion & exclusion 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.


Age minimum: 18 Year(s)
Age maximum: 60 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Ebola Virus Disease

Ebola Virus Disease

Intervention(s)

Placebo

GamEvac-Combi ¿ Combined Vector-Based Vaccine against Ebola Virus Disease

Primary Outcome(s)

the determination of immunity duration after the vaccination using ELISA method vs. baseline values and placebo

Secondary Outcome(s)

Safety Outcome

the assessment of antigen-specific cell-mediated immune responsevs baseline values and placebo

determination of immunity duration in virus neutralization reaction

Source(s) of Monetary Support

Federal Research Centre for Epidemiology and Microbiology named after N.F. Gamaleya

Ethics review

Status: Approved
Approval date: 16/02/2016
Contact:

Ministry of Health of the Russian Federation

Status: Approved
Approval date: 20/06/2016
Contact:

comite national d'ethique pour la recherche en sante